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 @ 12:24 AM
Ignite Modification Date: 2025-12-25 @ 10:29 PM
NCT ID: NCT02227758
Description: Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT02227758
Study Brief: Peripheral Nerve Stimulation Registry for Intractable Migraine Headache
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Implanted Chronic Migraine Patients Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system who experienced a Serious Device related adverse event None None 26 112 7 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breakage/facture of the extension None Product Issues None View
Device Malfunction None Product Issues None View
IPG migration None Skin and subcutaneous tissue disorders None View
Infection: IPG and lead site None Infections and infestations None View
Infection: lead site only None Infections and infestations None View
Lead breakage/fracture None Product Issues None View
Lead migration None Skin and subcutaneous tissue disorders None View
persistant pain and/or numbness: IPG site only None Skin and subcutaneous tissue disorders None View
persistant pain and/or numbness: lead site only None Skin and subcutaneous tissue disorders None View
persistent pain at connector site None Skin and subcutaneous tissue disorders None View
skin erosion None Skin and subcutaneous tissue disorders None View
Wound site complications None Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Persistent pain and/or numbness None Surgical and medical procedures None View