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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT01931202
Description: Adverse events were collected during weekly visit with the patients.
Frequency Threshold: 0
Time Frame: Adverse events were collected through the 8 week period of the study.
Study: NCT01931202
Study Brief: Mechanisms of Antidepressant Non-Response 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
Double Blind-Placebo Group Blinded treatment with placebo, 1 pill a day for 4 weeks. At week 4, if patients have not remitted, they were increased to 2 pills a day. 0 None 0 8 0 8 View
Double Blind-Escitalopram Group Blinded treatment with either escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age. 0 None 2 51 0 51 View
Open Treatment With Escitalopram Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4. Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age. 0 None 1 49 0 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):