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 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:05 AM
NCT ID: NCT03369418
Description: The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
Frequency Threshold: 0
Time Frame: Adverse events were collected during the study period (10 weeks).
Study: NCT03369418
Study Brief: Effectiveness of CES on Emotional and Cellular Wellbeing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur. Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia 0 None 0 13 2 13 View
Inactive Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur. Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. 0 None 0 11 6 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders patient description View
ear infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders patient description View
increased irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders patient description View
upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders patient description View
vitamin d deficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders patient description View
headahce NON_SYSTEMATIC_ASSESSMENT Nervous system disorders patient description View
panic attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders patient description View
insomnia NON_SYSTEMATIC_ASSESSMENT General disorders patient description View