Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
NCT ID:
NCT04237792
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.
Frequency Threshold:
0
Time Frame:
Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Study:
NCT04237792
Study Brief:
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Middle Dose: Age >=1 Month to <2 Years | 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. | 0 | None | 0 | 21 | 20 | 21 | View |
| High Dose: Age >=1 Month to <2 Years | 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. | 0 | None | 0 | 18 | 17 | 18 | View |
| Combined Dose: Age >=1 Month to <2 Years | 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). | 0 | None | 0 | 59 | 56 | 59 | View |
| Middle Dose: Age >=2 Years to <17 Years | 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. | 0 | None | 0 | 21 | 19 | 21 | View |
| High Dose: Age >=2 Years to <17 Years | 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. | 0 | None | 1 | 20 | 19 | 20 | View |
| Combined Dose: Age >=2 Years to <17 Years | 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). | 0 | None | 1 | 63 | 57 | 63 | View |
| Low Dose: Age >=1 Month to <2 Years | 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. | 0 | None | 0 | 20 | 19 | 20 | View |
| Low Dose: Age >=2 Years to <17 Years | 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. | 0 | None | 0 | 22 | 19 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Rebound tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Sinus arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Arnold-Chiari malformation | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Syringomyelia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Anaesthetic complication neurological | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Bradypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Diastolic hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Diastolic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Systolic hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Withdrawal hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |