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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT04366258
Description: systematic assessment (study MD monitored for AEs at every post-intervention visit)
Frequency Threshold: 0
Time Frame: 4 weeks
Study: NCT04366258
Study Brief: Transcranial Near Infrared Radiation and Cerebral Blood Flow in 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
t-PBM at High Irradiance At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2). 0 None 0 27 6 27 View
t-PBM at Medium Irradiance At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2). 0 None 0 26 7 26 View
Sham At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2). 0 None 0 29 6 29 View
t-PBM at Low Irradiance At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2). 0 None 0 28 8 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Warm Skin (forehead) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Skin Pressure (forehead) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Claustrophobia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nightmares SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Eye Irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View