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 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:43 PM
NCT ID: NCT01197950
Description: We did not expected any adverse event except for infections in the injection area or after the acupuncture needles were removed.
Frequency Threshold: 0
Time Frame: Three hours
Study: NCT01197950
Study Brief: Acupuncture With Manual and Electrical Stimulation to Reduce Labour 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
Manual Acupuncture Manual stimulation Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. 99 None 0 99 0 99 View
Electro Acupuncture Electrical and manual stimulation Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold. 103 None 0 103 0 103 View
Standard Care Standard care - no acupuncture treatment at all 101 None 0 101 0 101 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Only minor adverse events were expected SYSTEMATIC_ASSESSMENT Infections and infestations Other View