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 @ 2:12 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT01401595
Description: None
Frequency Threshold: 5
Time Frame: Duration of the study - 12 weeks, open label with escitalopram oxalate
Study: NCT01401595
Study Brief: Brain Imaging and Treatment Studies of the Night Eating Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Night Eating Syndrome Open Label Treatment Group Only the 32 participants with NES participated in the open label escitalopram treatment trial. One participant did not return after the first visit, and it is unknown if she ever started the medication. Thus 31 participants were included in the statistical analyses. None None 0 31 5 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
drowsiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
increased sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
impotence/low libido NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
mental cloudiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View