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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT02933034
Description: None
Frequency Threshold: 0
Time Frame: Baseline to end of study (average 616 days)
Study: NCT02933034
Study Brief: Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Coronary Disease Patients Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as a reagent); and DEMRI (gadolinium 0.2 mmol/kg as a reagent). 0 None 0 33 14 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
chest pain SYSTEMATIC_ASSESSMENT General disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
lip numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
malaise SYSTEMATIC_ASSESSMENT General disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
mild discomfort SYSTEMATIC_ASSESSMENT General disorders None View
mild jaw pain SYSTEMATIC_ASSESSMENT General disorders None View
mild weakness of feet SYSTEMATIC_ASSESSMENT General disorders None View