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: 2025-12-24 @ 7:39 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT03589703
Description: None
Frequency Threshold: 0
Time Frame: from start of intervention to end of intervention (4 weeks)
Study: NCT03589703
Study Brief: Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
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-APA Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. 0 None 0 92 69 92 View
NT-APA The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). 0 None 0 91 48 91 View
Enhanced Educational Control Group (CG-2) Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups. Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet. 0 None 0 89 0 89 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Itching/Discomfort on the ear where the seed was placed SYSTEMATIC_ASSESSMENT General disorders None View