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 @ 11:09 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT01023269
Description: None
Frequency Threshold: 0
Time Frame: Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.
Study: NCT01023269
Study Brief: Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Enrolled Patients Adverse events in this study were reported on the 17 enrolled patients. Due to the small number of patients in each group, the summary on adverse events was provided for the combined groups. 0 None 1 17 7 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection of the device stimulator SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
URINARY INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
pain after surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Battery empty at 07h30 and return of symptoms SYSTEMATIC_ASSESSMENT Investigations None View
Lead cut by the nurse SYSTEMATIC_ASSESSMENT Investigations None View