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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT03527160
Description: Adverse events were defined as any sign, symptoms, illness, clinically significant abnormal laboratory value or other adverse medical event the appeared for the first time or worsened during participation in the study AND were associated with the intervention in the study - urine collection. Serious adverse events were study defined adverse events that were considered life-threatening. Only events considered associated with the intervention in the study - urine collection- were collected.
Frequency Threshold: 5
Time Frame: Maximum of 9 days of exposure
Study: NCT03527160
Study Brief: Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NINJA Inpatients exposed to nephrotoxic medications 0 None 0 113 0 113 View
Serious Events(If Any):
Other Events(If Any):