Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 6:49 PM
Ignite Modification Date: 2025-12-25 @ 4:21 PM
NCT ID: NCT03036657
Description: Risk for SAEx was minimal. The study was minimally invasive, consisted placement of 2 acupuncture needles in the forearm per visit. The risk for all-cause Mortality was negligible due to the exclusion criteria eliminating multiple serious pre-existing conditions. The number of participants at risk of unanticipated adverse events was negligible as the study was considered minimally invasive.
Frequency Threshold: 0
Time Frame: Adverse event data were collected for the period of study enrollment, which ended after completion of visit #2 at week #2. In addition, participants were encouraged to contact the PI and the IRB with any issues of concerns after exiting the study.
Study: NCT03036657
Study Brief: Local Effects of Acupuncture and Nerve Conduction Studies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Manual Acupuncture Device: Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea Used for Intervention: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min MAC acupuncture needles: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min 0 None 0 20 0 20 View
High-Frequency Electroacupuncture Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA Used for Intervention: High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture Used for Interventions: High-frequency Continuous Electroacupuncture - 100 Hz to PC3, PC5 or HT3, HT4 for 20 min 0 None 0 20 0 20 View
Low-Frequency Electroacupuncture Device: Electrostimulator 6c.Pro, Pantheon Research, Venice, CA Used for Intervention: Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture Used for Interventions: Low-frequency Continuous Electroacupuncture - 4 Hz to PC3, PC5 or HT3, HT4 for 20 min AND 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):