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 @ 11:09 PM
Ignite Modification Date: 2025-12-25 @ 8:42 PM
NCT ID: NCT00321269
Description: Participants indicating depression were assessed for suicidality and any mortality due to suicide was monitored. These were the only adverse events monitored specifically. Suicidal ideation was assessed using the Beck Depression Inventory (Question #9) and the Structured Clinical Interview for DSM (Suicidal ideation question).
Frequency Threshold: 0
Time Frame: 8 weeks- duration of the clinical trial. Adverse event was assessed at Week 4 and Week 8.
Study: NCT00321269
Study Brief: Depression and Congestive Heart Failure in Outpatients.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
8-week Telephone Based Single Illness Management Standard nursing intervention to treat Congestive Heart Failure Education \& behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure None None 0 66 0 66 View
8-Week Phone Based Comorbid Illness Management Nursing intervention to treat Congestive Heart Failure and emotional coping CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping None None 0 68 0 68 View
Serious Events(If Any):

Serious Events

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