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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT01971567
Description: None
Frequency Threshold: 0
Time Frame: 16-18 weeks after completion of the intervention
Study: NCT01971567
Study Brief: High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIRREM High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time. HIRREM 0 None 0 56 6 56 View
Placebo Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes. HIRREM 0 None 0 51 7 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Change in sleep NON_SYSTEMATIC_ASSESSMENT General disorders None View
Change in emotions or awareness of feelings NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Head fullness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin irritation at scalp sensor site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View