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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT00841269
Description: Healthy comparison participants were only seen for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
Frequency Threshold: 5
Time Frame: Adverse events were collected from participants at every visit, starting after the treatment intervention was dispensed at baseline. Adverse events were assessed up to 6 weeks.
Study: NCT00841269
Study Brief: Oral Uridine for Treatment of Bipolar Depression in Adolescents
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Uridine 500 mg by Mouth Twice Daily for 6 Weeks Because this was an open-label study, all participants received the investigational drug uridine. 0 None 1 20 6 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal cramp, Nausea, Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flu-like symptoms (fatigue, bronchitis, sinusitis) SYSTEMATIC_ASSESSMENT General disorders None View
Hordeolum SYSTEMATIC_ASSESSMENT Eye disorders None View
Back pain SYSTEMATIC_ASSESSMENT General disorders None View
Vivid Dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View