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 @ 10:20 PM
Ignite Modification Date: 2025-12-25 @ 7:53 PM
NCT ID: NCT01658735
Description: None
Frequency Threshold: 0
Time Frame: Within 12 weeks the participant was enrolled
Study: NCT01658735
Study Brief: Comparison of Electrotherapies for Chronic Low Back 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
H-Wave Device H-Wave Device with Usual Care H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect. None None 0 39 2 39 View
TENS Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding. None None 0 36 2 36 View
Sham Electrotherapy Sham Device plus Usual Care. Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical. None None 0 38 1 38 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increase in Lower Extremity Tingling/Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Exacerbation of Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain/Flank pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View