Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-29 @ 12:10 PM
Study NCT ID:
NCT04237792
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2020-01-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Combined Dose: Age >=1 Month to <2 Years', 'description': 'Participants were randomized to receive a loading dose of DEX 0.5 mcg/kg (low dose), 1 mcg/kg (middle dose), and 1.5 mcg/kg (high dose) over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour (low dose), 1 mcg/kg/hour (middle dose), and 1.5 mcg/kg/hour (high dose).', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 56, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 19, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 19, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Combined Dose: Age >=2 Years to <17 Years', 'description': 'Participants were randomized to receive a loading dose of DEX 0.5 mcg/kg (low dose), 1.2 mcg/kg (middle dose), and 2 mcg/kg (high dose) over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour (low dose), 1 mcg/kg/hour (middle dose), and 1.5 mcg/kg/hour (high dose).', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 57, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 41}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rebound tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Arnold-Chiari malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Syringomyelia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Anaesthetic complication neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Bradypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diastolic hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diastolic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Systolic hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Withdrawal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'seriousEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '78.0'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '29.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.29', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '74.0'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '38.0'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '51.0', 'upperLimit': '91.0'}, {'value': '13.6', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '35.0'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.82', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.26', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '42', 'groupId': 'OG007'}, {'value': '42', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG005', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG006', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG007', 'title': 'Middle Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG008', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '61.9', 'groupId': 'OG004'}, {'value': '13.6', 'groupId': 'OG005'}, {'value': '63.2', 'groupId': 'OG006'}, {'value': '35.7', 'groupId': 'OG007'}, {'value': '14.3', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.59', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.597', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '0.25', 'ciUpperLimit': '11.27', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.374', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.14', 'ciUpperLimit': '2.07', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.44', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.015', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.81', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.024', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.87', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '41', 'groupId': 'OG007'}, {'value': '38', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG006', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG007', 'title': 'Middle Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG008', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '15.94', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '12.04', 'groupId': 'OG001'}, {'value': '87.8', 'spread': '23.93', 'groupId': 'OG002'}, {'value': '76.8', 'spread': '18.36', 'groupId': 'OG003'}, {'value': '92.2', 'spread': '9.72', 'groupId': 'OG004'}, {'value': '94.1', 'spread': '12.22', 'groupId': 'OG005'}, {'value': '77.2', 'spread': '17.04', 'groupId': 'OG006'}, {'value': '87.2', 'spread': '11.88', 'groupId': 'OG007'}, {'value': '91.1', 'spread': '18.71', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.225', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.213', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG005'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.006', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.011', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG006', 'OG008'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.004', 'groupIds': ['OG006', 'OG007'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '42', 'groupId': 'OG007'}, {'value': '38', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG006', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG007', 'title': 'Middle Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG008', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '21.0'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '25.0'}, {'value': '62.0', 'comment': 'Upper value of 95 % confidence interval (CI) could not be estimated due to less number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': 'NA'}, {'value': '16.5', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': '25.0'}, {'value': 'NA', 'comment': 'Median and upper value of 95 % CI could not be estimated due to less number of participants with event.', 'groupId': 'OG004', 'lowerLimit': '31.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper value of 95 % CI could not be estimated due to less number of participants with event.', 'groupId': 'OG005', 'lowerLimit': '72.0', 'upperLimit': 'NA'}, {'value': '16.0', 'groupId': 'OG006', 'lowerLimit': '15.0', 'upperLimit': '20.0'}, {'value': '31.5', 'groupId': 'OG007', 'lowerLimit': '17.0', 'upperLimit': '64.0'}, {'value': 'NA', 'comment': 'Median and upper value of 95 % CI could not be estimated due to less number of participants with event.', 'groupId': 'OG008', 'lowerLimit': '45.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.358', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.000', 'groupIds': ['OG003', 'OG005'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.020', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.000', 'groupIds': ['OG006', 'OG008'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.005', 'groupIds': ['OG006', 'OG007'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Participants who did not have PRO administered were censored.', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX.'}, {'type': 'SECONDARY', 'title': 'Emergence Time - By Age Cohort and Combined Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '42', 'groupId': 'OG007'}, {'value': '38', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG006', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG007', 'title': 'Middle Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG008', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '59.0'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '34.0', 'upperLimit': '54.0'}, {'value': '38.0', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '51.0'}, {'value': '35.0', 'groupId': 'OG003', 'lowerLimit': '21.0', 'upperLimit': '49.0'}, {'value': '46.0', 'groupId': 'OG004', 'lowerLimit': '25.0', 'upperLimit': '64.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '35.0', 'upperLimit': '62.0'}, {'value': '35.0', 'groupId': 'OG006', 'lowerLimit': '21.0', 'upperLimit': '41.0'}, {'value': '42.5', 'groupId': 'OG007', 'lowerLimit': '35.0', 'upperLimit': '52.0'}, {'value': '45.5', 'groupId': 'OG008', 'lowerLimit': '35.0', 'upperLimit': '54.0'}]}]}], 'analyses': [{'pValue': '0.884', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.662', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.236', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.733', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.128', 'groupIds': ['OG003', 'OG005'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.165', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.752', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.139', 'groupIds': ['OG006', 'OG008'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.051', 'groupIds': ['OG006', 'OG007'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post MRI scan on Day 1 up to 24 hours', 'description': 'Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score \\>=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score \\>=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia.', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received PRO - By Age Cohort and Combined Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '42', 'groupId': 'OG007'}, {'value': '38', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG006', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG007', 'title': 'Middle Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG008', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX.'}, {'type': 'SECONDARY', 'title': 'Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG006', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG007', 'title': 'Middle Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG008', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '4012.1', 'spread': '2334.66', 'groupId': 'OG000'}, {'value': '4730.3', 'spread': '3398.21', 'groupId': 'OG001'}, {'value': '2822.8', 'spread': '1593.84', 'groupId': 'OG002'}, {'value': '5559.2', 'spread': '4038.95', 'groupId': 'OG003'}, {'value': '5001.9', 'spread': '4093.70', 'groupId': 'OG004'}, {'value': '4513.0', 'spread': '4620.56', 'groupId': 'OG005'}, {'value': '4828.6', 'spread': '3390.42', 'groupId': 'OG006'}, {'value': '4810.7', 'spread': '3538.71', 'groupId': 'OG007'}, {'value': '3426.4', 'spread': '2973.00', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '0.124', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.186', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.470', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.845', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.621', 'groupIds': ['OG003', 'OG005'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.747', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.218', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.181', 'groupIds': ['OG006', 'OG008'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.984', 'groupIds': ['OG006', 'OG007'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'unitOfMeasure': 'mcg per kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Participants aged \\>=1 month to \\< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG006', 'title': 'Low Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG007', 'title': 'Middle Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}, {'id': 'OG008', 'title': 'High Dose: Combined Age', 'description': 'Participants aged \\>=1 month to \\<2 years and \\>=2 years to \\<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.43', 'spread': '18.625', 'groupId': 'OG000'}, {'value': '71.38', 'spread': '32.895', 'groupId': 'OG001'}, {'value': '47.41', 'spread': '14.454', 'groupId': 'OG002'}, {'value': '81.28', 'spread': '38.406', 'groupId': 'OG003'}, {'value': '74.70', 'spread': '24.487', 'groupId': 'OG004'}, {'value': '76.36', 'spread': '47.656', 'groupId': 'OG005'}, {'value': '70.96', 'spread': '32.243', 'groupId': 'OG006'}, {'value': '72.28', 'spread': '30.418', 'groupId': 'OG007'}, {'value': '56.31', 'spread': '30.007', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.106', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.940', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.824', 'groupIds': ['OG003', 'OG005'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.678', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.129', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.160', 'groupIds': ['OG006', 'OG008'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.872', 'groupIds': ['OG006', 'OG007'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'unitOfMeasure': 'mcg per kg per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received any amount of DEX. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Day 1: Participants aged \\>=1 month to \\<2 years, were randomized to receive a loading dose of DEX 0.5 microgram per kilogram (mcg/kg) over 10 minutes as intravenous (IV) infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per physical investigator (PI) clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'FG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Day 1: Participants aged \\>=1 month to \\<2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'FG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Day 1: Participants aged \\>=1 month to \\<2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'FG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Day 1: Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'FG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Day 1: Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'FG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Day 1: Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}], 'periods': [{'title': 'Treatment (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'Treated With DEX', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'MRI Scan (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'DEX infusion could be discontinued during MRI scan, if clinically indicated.', 'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'comment': 'DEX infusion could be discontinued during MRI scan, if clinically indicated.', 'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'comment': 'DEX infusion could be discontinued during MRI scan, if clinically indicated.', 'groupId': 'FG004', 'numSubjects': '21'}, {'comment': 'DEX infusion could be discontinued during MRI scan, if clinically indicated.', 'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Post MRI Scan Recovery (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Follow-up (FU) (Day 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Long Term FU (Any Day From Day 29 to 32)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total 141 participants were screened. Out of 141 participants, only 128 participants who met eligibility criteria signed the informed consent document, were enrolled and randomized. Out of 128 randomized participants, 6 participants were not treated.', 'preAssignmentDetails': 'Pediatric participants were administered with dexmedetomidine (DEX), and with propofol (PRO) as needed, for procedural sedation for magnetic resonance imaging (MRI) scans.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '122', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose: Age >=1 Month to <2 Years', 'description': 'Day 1: Participants aged \\>=1 month to \\<2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'BG001', 'title': 'Middle Dose: Age >=1 Month to <2 Years', 'description': 'Day 1: Participants aged \\>=1 month to \\<2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'BG002', 'title': 'High Dose: Age >=1 Month to <2 Years', 'description': 'Day 1: Participants aged \\>=1 month to \\<2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'BG003', 'title': 'Low Dose: Age >=2 Years to <17 Years', 'description': 'Day 1: Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'BG004', 'title': 'Middle Dose: Age >=2 Years to <17 Years', 'description': 'Day 1: Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'BG005', 'title': 'High Dose: Age >=2 Years to <17 Years', 'description': 'Day 1: Participants aged \\>=2 years to \\<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '0.612', 'groupId': 'BG000'}, {'value': '0.90', 'spread': '0.488', 'groupId': 'BG001'}, {'value': '0.96', 'spread': '0.384', 'groupId': 'BG002'}, {'value': '6.68', 'spread': '2.922', 'groupId': 'BG003'}, {'value': '7.40', 'spread': '3.230', 'groupId': 'BG004'}, {'value': '6.63', 'spread': '3.277', 'groupId': 'BG005'}, {'value': '4.02', 'spread': '3.743', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '63', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '100', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants who received any amount of DEX.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-11', 'size': 4473643, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-18T10:52', 'hasProtocol': True}, {'date': '2021-06-09', 'size': 1659461, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-18T10:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2020-01-17', 'resultsFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-18', 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.'}, {'measure': 'Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure.'}, {'measure': 'Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation.'}, {'measure': 'Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1', 'description': 'Participants who did not have PRO administered were censored.'}, {'measure': 'Emergence Time - By Age Cohort and Combined Age', 'timeFrame': 'Post MRI scan on Day 1 up to 24 hours', 'description': 'Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score \\>=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score \\>=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia.'}, {'measure': 'Number of Participants Who Received PRO - By Age Cohort and Combined Age', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1'}, {'measure': 'Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1'}, {'measure': 'Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age', 'timeFrame': 'Up to maximum of 3 hours during MRI scan on Day 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['procedural sedation', 'dexmedetomidine', 'propofol', 'MRI'], 'conditions': ['MRI Sedation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C0801039', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to \\<17 years of age undergoing MRI scans in the US and Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Male or female subject ≥1 month and \\<17 years of age.\n2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.\n3. Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance.\n4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete\n\nKey Exclusion Criteria:\n\n1. Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.\n2. Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts.\n3. Planned medical procedure during the MRI scan or post-MRI recovery period.\n4. Requires endotracheal intubation or laryngeal mask airway (LMA).\n5. Known allergy to eggs, egg products, soybeans or soybean products.\n6. SpO2 \\<93 % on room air -'}, 'identificationModule': {'nctId': 'NCT04237792', 'briefTitle': 'Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3/4 RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF DEXMEDETOMIDINE (DEX) USED WITH PROPOFOL (PRO) AS NEEDED FOR PROCEDURAL SEDATION OF PEDIATRIC SUBJECTS ≥1 MONTH TO <17 YEARS OF AGE UNDERGOING MRI SCANS', 'orgStudyIdInfo': {'id': 'C0801039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine low dose group', 'description': 'low dose of dexmedetomidine to be given', 'interventionNames': ['Drug: dexmedetomidine', 'Drug: propofol']}, {'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine middle dose group', 'description': 'middle dose of dexmedetomidine to be given', 'interventionNames': ['Drug: dexmedetomidine', 'Drug: propofol']}, {'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine high dose group', 'description': 'high dose of dexmedetomidine to be given', 'interventionNames': ['Drug: dexmedetomidine', 'Drug: propofol']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'description': 'dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan', 'armGroupLabels': ['dexmedetomidine high dose group', 'dexmedetomidine low dose group', 'dexmedetomidine middle dose group']}, {'name': 'propofol', 'type': 'DRUG', 'description': 'propofol IV administration will be given if needed to maintain sedation', 'armGroupLabels': ['dexmedetomidine high dose group', 'dexmedetomidine low dose group', 'dexmedetomidine middle dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital, Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Baptist Health - Wolfson Children's Hospital", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "St. Mary's Medical Center", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta-Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48109-4245', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "University of Michigan, C.S. Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'M Health Fairview University of Minnesota Medical Center - West Bank', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Brody School of Medicine at East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vidant Medical Center', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "University Hospitals Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "The Children's Hospital at OUMC", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '311-4145', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Ibaraki Children Hospital', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '765-8507', 'city': 'Zentsujichó', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Shikoku Medical Center for Children and Adults', 'geoPoint': {'lat': 34.22699, 'lon': 133.77791}}, {'zip': '594-1101', 'city': 'Izumi-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': "Osaka Women's and Children's Hospital"}, {'zip': '420 8660', 'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'facility': "Shizuoka Children's Hospital", 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '183-8561', 'city': 'Fuchū', 'state': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Metropolitan Children's Medical Center", 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Center for Child Health and Development'}, {'zip': '534-0021', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City General Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}