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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT05610267
Description: Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Frequency Threshold: 0
Time Frame: Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months
Study: NCT05610267
Study Brief: Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral 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
Device: Retrospective Chart Review Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix. 0 None 3 28 13 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Volvulus of small bowel SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Incisional hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Postoperative adhesion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intestinal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Application site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Instillation site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Abdominal wall abscess SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Abdominal wall infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Iatrogenic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Abscess drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View