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: 2025-12-26 @ 5:23 PM
Ignite Modification Date: 2025-12-26 @ 5:23 PM
NCT ID: NCT03779906
Description: Subjects were monitored for any untoward medical occurrences from the time of signed Informed Consent through the timeframe associated with the investigational medicinal product administration. All untoward medical occurrences were recorded in the Adverse Event section of the CRF.
Frequency Threshold: 0
Time Frame: As this was an Observational Study, untoward medical occurrences (i.e., adverse events) were monitored through completion of the exam with administration of ISOVUE, up to 1 week for subjects dosed as part of their routine standard of care.
Study: NCT03779906
Study Brief: Thyroid Function of Pediatric Subjects Following Isovue® Administration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ISOVUE Intravascular administration of ISOVUE as part of a subject's standard of care examination. 0 None 1 17 0 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Other Events(If Any):