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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT03261505
Description: None
Frequency Threshold: 0
Time Frame: Through the whole interventions, average about one month.
Study: NCT03261505
Study Brief: Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VGAIT Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. 0 None 0 30 0 30 View
VGAIT Control Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. 0 None 0 30 0 30 View
Real Acupuncture Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. 0 None 0 34 1 34 View
Sham Acupuncture Acupuncture: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment. 0 None 0 31 0 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ringing of ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View