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 @ 2:23 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT01896934
Description: Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT01896934
Study Brief: Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sertraline 50-200mg daily 0 None 0 21 14 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vision changes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vivid Dreams NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sexual Dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View