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 @ 11:00 PM
Ignite Modification Date: 2025-12-25 @ 8:29 PM
NCT ID: NCT02388269
Description: None
Frequency Threshold: 0
Time Frame: Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
Study: NCT02388269
Study Brief: A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G
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®-G FD Active Comparator: Active gammaCore device gammaCore active stimulation treatment 0 None 0 20 15 20 View
gammaCore®-G Sham FD Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment 0 None 0 20 13 20 View
gammaCore®-G IBS Active Comparator: Active gammaCore device gammaCore active stimulation treatment 0 None 0 21 16 21 View
gammaCore®-G Sham IBS Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment 0 None 0 20 16 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MEDRA View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MEDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MEDRA View
Blepharospasm NON_SYSTEMATIC_ASSESSMENT Eye disorders MEDRA View
Conjunctivitis Allergic NON_SYSTEMATIC_ASSESSMENT Eye disorders MEDRA View
Mydriasis NON_SYSTEMATIC_ASSESSMENT Eye disorders MEDRA View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Food Poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Irritable bowel syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Odynophagia NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Paraethesia Oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Tenderness NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA View
Otitis externa NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA View
Ligament Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA View
Muscle Strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA View
Stress Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA View
Tendon injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDRA View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Muscle Spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Osteitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Pain in Jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Disturbance in attention NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Hypokinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA View
Panic Attack NON_SYSTEMATIC_ASSESSMENT Product Issues MEDRA View
Renal Colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDRA View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDRA View
Respiratory Tract Ulceration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View
Dermatitis Allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View
Skin Irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View
Swelling face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MEDRA View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA View
MuscleTwitching NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MEDRA View
Skin Lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA View