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 @ 4:47 AM
Ignite Modification Date: 2025-12-26 @ 3:49 AM
NCT ID: NCT03547518
Description: Adverse events were collected at each visit by asking the participant if there were any changes to their medical history, hospitalizations, or new acute conditions.
Frequency Threshold: 0
Time Frame: Adverse events were collected for 12 weeks in active treatment group and sham treatment groups. Sham patients that continued to the open label active PTNS treatment phase were monitored for 12 weeks.
Study: NCT03547518
Study Brief: Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active PTNS Treatment One-week induction consisting of three active PTNS treatments, each 2 hours long PTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long 0 None 0 13 6 13 View
Sham Treatment One-week induction consisting of three sham treatments, each 2 hours long Sham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long 0 None 0 12 2 12 View
Open Label Active PTNS Treatment Sham participants that continued to the open label active PTNS treatment phase. One- week induction consisting of three active PTNS treatments, each 2 hours long. 0 None 0 12 3 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atypical Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Asthmatic bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary Tract Infection (UTI) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right lower extremity cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Right foot fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
COVID infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right lower extremity tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View