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 @ 9:59 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT01010932
Description: Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Frequency Threshold: 1
Time Frame: Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Study: NCT01010932
Study Brief: Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Computerized Tomography Angiography (CTA) Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium None None 2 200 7 200 View
Dotarem MRA Patients benefiting from a MR angiography after an IV administration of Dotarem None None 1 200 12 200 View
TOF MRA Patients benefiting from a MR angiography with no contrast medium administration None None 0 200 0 200 View
Patients Discontinued Without Dotarem Administration Patients withdrawn before administration of Dotarem whatever the reason None None 1 22 2 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site hematoma SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil Count increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View