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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT02000908
Description: None
Frequency Threshold: 0
Time Frame: 16 weeks
Study: NCT02000908
Study Brief: Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Realief Therapy Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. 0 None 0 30 0 30 View
Sham Treatment The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control. After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy Physiotherapy: Chiropractic massage and lymphedema treatment 0 None 0 40 1 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Superficial Burn NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View