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 @ 11:34 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT03350256
Description: None
Frequency Threshold: 5
Time Frame: From enrollment to completion of the study at 6 month follow up.
Study: NCT03350256
Study Brief: BurstDR™ micrOdosing stimuLation in De-novo Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Microdosing Group Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. 0 None 2 60 3 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Subject fractured <1 vertebrae (compression) and was hospitalized overnight NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization for abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Trial lead migration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View