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 @ 4:47 PM
Ignite Modification Date: 2025-12-25 @ 2:33 PM
NCT ID: NCT01667250
Description: None
Frequency Threshold: 0
Time Frame: Up to 8 weeks - duration of the Randomized period
Study: NCT01667250
Study Brief: Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GammaCore Sham Device Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. 0 None 0 29 5 29 View
GammaCore Active Device Subjects will use an Active GammaCore Device GammaCore Active Device 0 None 2 30 6 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening of Headache Pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Altered sensations (brain zaps) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migratory Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Right arm (hand) tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Right eye twitching NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lip twiching NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intermittent Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Lip numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Blister at treatment site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
General malaise NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sore throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash at treatment site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Worsening of migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Blisters at treatment site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash/Blister at treatment site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Redness at treatment site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Exacerbated migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Atypical migraine pain with associated blackouts NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Mild pains in head and right arm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Severe migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View