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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT00346905
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT00346905
Study Brief: Endoscopic Implantation of Enteryx for the Treatment of GERD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 - Single Arm Those experiencing GERD None None 10 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Throat Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Severe Chest Pain / Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Flutter Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Retrosternal Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Malignant Nodule in Thyroid SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chemical Mediastinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pleuritic Chest Pain with Inspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Torn Rotator Cuff SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hiatal Hernia Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nissen Fundoplication for Severe GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bleeding Esophageal Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain secondary to Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rigors "Shaking Chills" SYSTEMATIC_ASSESSMENT General disorders None View
C-Diff Colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heart Attack SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nissen Fundoplication Repair with Hospital Stay for GERD and Pulmonary Symptoms SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nissen Fundoplication for GERD. Hospitalized for 2 days post surgery. SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diverticulosis of Sigmoid Colon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Excessive Gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Patient with complaint of left lateral wall discomfort in left axilla. Occasional/short lasting SYSTEMATIC_ASSESSMENT General disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Low grade fever SYSTEMATIC_ASSESSMENT General disorders None View
Minor Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
More servere hearburn than Baseline SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Burping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sinusitis with asthma exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening of asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthma Attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bleeding gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Exacerbation of reflux due to medication taken for pneumonia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
High Blood Pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral illness accompanied by headache, nauseau, and vomiting SYSTEMATIC_ASSESSMENT Infections and infestations None View
Torn ligmament in left shoulder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Cold like symtoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Exacerbated GERD symptoms - gagging, coughing, mucus due to stress when patient's mother was ill. SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsening of GERD Symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
More severe heartburn than baseline SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Exacerbation of GERD symptoms similar to baseline SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increase in severity of nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthma Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increased Burping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Retrosternal Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty Swallowing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Trouble Swallowing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worse Than Ever Heartburn. Woke Pt. from Sleep. SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Herniated Cervical Disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthritic low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in the middle of Chest brought on by physical activity SYSTEMATIC_ASSESSMENT General disorders None View
Retrosternal Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of Breath brough on by physical activity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hiatal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Schatzski's Ring SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View