Adverse Events Module

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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: 2025-12-25 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT01519167
Description: None
Frequency Threshold: 1
Time Frame: Non-serious adverse events from start of study drug administration until 24(±12) hours following study drug discontinuation. Reported serious adverse events from the time the subject signed informed consent until 30 days after study drug discontinuation.
Study: NCT01519167
Study Brief: Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose Level 1 Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr None None 0 1 1 1 View
Dose Level 2 Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr None None 1 89 66 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Blood pressure diastolic decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (14.1) View
Blood pressure systolic decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (14.1) View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (14.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.1) View
Respiratory depression SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.1) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (14.1) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (14.1) View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (14.1) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (14.1) View