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 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:14 AM
NCT ID: NCT00570505
Description: None
Frequency Threshold: 1
Time Frame: 5 years
Study: NCT00570505
Study Brief: Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LapBand Subjects implanted with the LapBand(R) Adjustable Gastric Band System None None 18 149 145 149 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal cavity abscess NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Umbilical hernia contained LAP-BAND tubing NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Recurrent gastric stricture NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Band slip NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Band erosion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric outlet obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Esophageal spasms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Gastric prolapse NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hiatal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Biliary colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pouch dilation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Esophageal obstruction NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric dilation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Esophageal dilation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Post procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Implant site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Regurgitation of food NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Medical device complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View