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 @ 6:35 PM
Ignite Modification Date: 2025-12-25 @ 4:05 PM
NCT ID: NCT00617357
Description: The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Frequency Threshold: 5
Time Frame: None
Study: NCT00617357
Study Brief: Repair of Infected or Contaminated Hernias
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Strattice None None None 50 80 20 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal wound dehiscence None Injury, poisoning and procedural complications None View
Anastomotic leak None Injury, poisoning and procedural complications None View
Arteriosclerosis obliterans None Vascular disorders None View
Ascites None Gastrointestinal disorders None View
Atrial fibrillation None Cardiac disorders None View
Bacteraemia None Infections and infestations None View
Cardiac arrest None Cardiac disorders None View
Catheter site infection None Infections and infestations None View
Cholecyctitis None Hepatobiliary disorders None View
Cholecyctitis chronic None Hepatobiliary disorders None View
Clostridium difficile toxin test positive None Investigations None View
Colostomy infection None Infections and infestations None View
Constipation None Gastrointestinal disorders None View
Coronary artery disease None Cardiac disorders None View
Dehydration None Metabolism and nutrition disorders None View
Delirium None Psychiatric disorders None View
Dysphagia None Gastrointestinal disorders None View
Folliculitis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Gastrointestinal stoma complication None Injury, poisoning and procedural complications None View
Haematuria None Renal and urinary disorders None View
Hydronephrosis None Renal and urinary disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View
Iatrogenic injury None Injury, poisoning and procedural complications None View
Ileus None Gastrointestinal disorders None View
Ileus paralytic None Gastrointestinal disorders None View
Incision site haematoma None Injury, poisoning and procedural complications None View
Incisional hernia None Injury, poisoning and procedural complications None View
Intestinal obstruction None Gastrointestinal disorders None View
Leukocytosis None Blood and lymphatic system disorders None View
Metabolic disorder None Metabolism and nutrition disorders None View
Multiple myeloma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myocardial infarction None Cardiac disorders None View
Osteomyelitis None Infections and infestations None View
Pancreatic fistula None Gastrointestinal disorders None View
Pancreatitis None Gastrointestinal disorders None View
Pelvic abscess None Infections and infestations None View
Peripheral ischaemia None Vascular disorders None View
Pneumonia None Infections and infestations None View
Post procedural fistula None Injury, poisoning and procedural complications None View
Postoperative respiratory distress None Injury, poisoning and procedural complications None View
Postoperative wound infection None Infections and infestations None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Renal failure acute None Renal and urinary disorders None View
Respiratory distress None Respiratory, thoracic and mediastinal disorders None View
Road traffic accident None Injury, poisoning and procedural complications None View
Sepsis None Infections and infestations None View
Seroma None Injury, poisoning and procedural complications None View
Small bowel obstruction None Gastrointestinal disorders None View
Small intestinal obstruction None Gastrointestinal disorders None View
Small intestinal stenosis None Gastrointestinal disorders None View
Suture related complication None Injury, poisoning and procedural complications None View
Urinary tract infection None Infections and infestations None View
Vomiting None Gastrointestinal disorders None View
Wound abscess None Infections and infestations None View
Wound complication None Injury, poisoning and procedural complications None View
Wound infection None Infections and infestations None View
Abdominal Pain None Gastrointestinal disorders None View
Abdominal abscess None Infections and infestations None View
Abdominal wall abscess None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Seroma None Injury, poisoning and procedural complications None View