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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT02456727
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks (12 weeks of treatment plus 12 weeks post-treatment)
Study: NCT02456727
Study Brief: Acupuncture Approaches for Chronic 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
Group Acupuncture Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks. 2 None 0 389 10 389 View
Individual Acupuncture Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks. 1 None 0 390 5 390 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Syncopal Symptoms NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Prolonged Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Prolonged Musculo-Skeletal Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Loss of vaccaria seed in ear NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View