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 @ 12:40 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT00562861
Description: All patients were systematically interviewed for the adverse events reported.
Frequency Threshold: 5
Time Frame: Adverse events are reported for 1 year of follow-up during the randomized trial.
Study: NCT00562861
Study Brief: Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Citalopram Mood stabilizers given as part of standard treatment plus double-blind citalopram None None 1 60 23 60 View
Placebo Mood stabilizers given as part of standard treatment plus double-blind placebo None None 0 59 15 59 View
Serious Events(If Any):

Serious Events

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

Other Events

Term Type Organ System Vocab View
sedation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sexual dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View