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 @ 4:35 AM
Ignite Modification Date: 2025-12-26 @ 3:37 AM
NCT ID: NCT04150718
Description: None
Frequency Threshold: 0
Time Frame: 1 month
Study: NCT04150718
Study Brief: Role of Slow-wave Activity and Plasticity in MDD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Subjects who get assigned to this group will undergo a Diagnostic and Statistical Manual for Mental Disorders (SCID) assessment to determine they do not meet criteria for MDD. slow-wave disruption: A tone will be played through a speaker mounted over the bed that disrupts subjects while they are in slow-wave sleep. The tone will not be loud enough to wake up. 0 None 0 20 1 20 View
Subjects With Major Depressive Disorder Subjects who get assigned to this group will undergo a Diagnostic and Statistical Manual for Mental Disorders (SCID) assessment to determine is they meet criteria for MDD. slow-wave disruption: A tone will be played through a speaker mounted over the bed that disrupts subjects while they are in slow-wave sleep. The tone will not be loud enough to wake up. 0 None 0 33 0 33 View
Ineligible/Withdrew Results are reported per Arm/Group, but data from participants who were ineligible or withdrew did not complete the study and therefore had no associated adverse events. 0 None 0 11 0 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View