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 @ 10:12 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT01775735
Description: None
Frequency Threshold: 0
Time Frame: Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.
Study: NCT01775735
Study Brief: Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve 0 None 4 8 3 8 View
Control The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Occipital nerve stimulator: Electrical stimulation of the greater occipital nerve 0 None 1 7 3 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Migraine None Nervous system disorders None View
Status migrainosus None Nervous system disorders None View
Hemiplegic migraine None Nervous system disorders None View
Migraine without aura None Nervous system disorders None View
Adverse drug reaction None General disorders None View
Cellulitis None Infections and infestations None View
Wound dehiscence None Injury, poisoning and procedural complications None View
Nephrolithiasis None Renal and urinary disorders None View
Thrombosis None Vascular disorders None View
Device related infection None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Implant site irritation None General disorders None View
Migraine None Nervous system disorders None View
Carpal tunnel syndrome None Nervous system disorders None View
Impaired healing None General disorders None View
Diverticulitis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Surgical skin tear None Injury, poisoning and procedural complications None View
Suture related complication None Injury, poisoning and procedural complications None View
Myofascial pain syndrome None Musculoskeletal and connective tissue disorders None View
Rotator cuff syndrome None Musculoskeletal and connective tissue disorders None View
Renal failure acute None Renal and urinary disorders None View
Hypotension None Vascular disorders None View
Drug hypersensitivity None Immune system disorders None View
Body temperature increased None Investigations None View