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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:57 AM
NCT ID: NCT02335502
Description: None
Frequency Threshold: 0
Time Frame: All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Study: NCT02335502
Study Brief: A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain
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 Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator None None 8 66 7 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dural puncture None Injury, poisoning and procedural complications None View
Hematoma/Infection None Injury, poisoning and procedural complications None View
Infection None Infections and infestations None View
Motor deficit-transient None Injury, poisoning and procedural complications None View
Return of symptoms/worsening of disease state None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematoma (became SAE) None Injury, poisoning and procedural complications None View
Infection None Infections and infestations None View
Infection (became SAE) None Infections and infestations None View
Loss of stimulation None Injury, poisoning and procedural complications None View
Pain at IPG site None Injury, poisoning and procedural complications None View
Spinal tap headache None Injury, poisoning and procedural complications None View