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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT02959827
Description: This study is a retrospective study using data from the database in United States. The safety outcome focused on the incidence of hypothyroidism for up to one year after iodine contrast exposure. Please refer to the result of primary outcome measure. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed during this retrospective observation study. Only retrospective safety outcome data were assessed, which are on the outcome measures module.
Frequency Threshold: 0
Time Frame: Incidence of hypothyroidism was assessed up to one year after iodine contrast exposure
Study: NCT02959827
Study Brief: Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Iodine Contrast Agent Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):