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 @ 5:14 PM
Ignite Modification Date: 2025-12-25 @ 2:51 PM
NCT ID: NCT02473250
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected over the time that the participants were enrolled in the study. This time range varied depending on the research procedures performed. If all research procedures were performed, the participants were enrolled for 11 weeks.
Study: NCT02473250
Study Brief: Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bipolar Depressed Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate) Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate). Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted. 0 None 2 40 0 40 View
Serious Events(If Any):

Serious Events

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