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 @ 1:09 AM
Ignite Modification Date: 2025-12-25 @ 11:20 PM
NCT ID: NCT02011893
Description: Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Frequency Threshold: 5
Time Frame: following enrollment through 6 months of treatment
Study: NCT02011893
Study Brief: SUNBURST (Success Using Neuromodulation With BURST) Study
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 Subjects All subjects who were enrolled in the SUNBURST clinical study None None 12 173 13 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Persistent pain and/or numbness None Injury, poisoning and procedural complications None View
Unsuccessful lead placement None Injury, poisoning and procedural complications None View
Abdominal pain None Hepatobiliary disorders None View
Bowel obstruction None Gastrointestinal disorders None View
Femur fracture None Injury, poisoning and procedural complications None View
Hip pain/hip replacement None Surgical and medical procedures None View
Low Potassium Levels None General disorders None View
Persistent pain and/or numbness None Injury, poisoning and procedural complications None View
Cancerous tumor on vocal chords None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Infection None Infections and infestations None View
Loss of speech and memory, and headache None Nervous system disorders None View
Scheduled right total knee arthroplasty None Surgical and medical procedures None View
Shortness of breath None Cardiac disorders None View
Somnolence None General disorders None View
Temporary paralysis None Nervous system disorders None View
Withdrawal symptoms from tapering off oxymorphone None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diminished or loss of symptom relief (Tonic Stimulation) None General disorders None View
Persistent pain and/or numbness None General disorders None View
Diminished or loss of symptom relief (Burst Stimulation) None General disorders None View