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: 2025-12-24 @ 12:49 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT01502761
Description: None
Frequency Threshold: 0
Time Frame: 90 days
Study: NCT01502761
Study Brief: Intra-arterial Magnesium Administration for Acute Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Regional Intra-arterial Magnesium 1.5g Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients Magnesium Sulfate: Intra-arterial 0 None 0 0 0 0 View
Regional/ Distal (75/25%) Magnesium 1.5g Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients Magnesium Sulfate: Intra-arterial 0 None 0 0 0 0 View
Regional Intra-arterial Magnesium 0.75g Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients Magnesium Sulfate: Intra-arterial 0 None 1 4 2 4 View
Regional/ Distal (50/50%) Magnesium 1.5g Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients Magnesium Sulfate: Intra-arterial 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aspiration Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Parotiditis with sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cerebral Edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischemic change on brain imaging SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhagic Transformation of stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sick Sinus Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aspiration Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
increased blood glucose SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View