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 @ 2:11 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT01644695
Description: None
Frequency Threshold: 1
Time Frame: Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
Study: NCT01644695
Study Brief: Review of Complex Recurrent Hernia Repair
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants No participant was excempt from this measure. None None 0 85 27 85 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 6 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DVT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neuroma SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infected Mesh SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Drain Issue SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Entrapped Nerve SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia Paresthetica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Further Surgery Required SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View