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 @ 3:15 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT00539292
Description: None
Frequency Threshold: 5
Time Frame: Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)
Study: NCT00539292
Study Brief: Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Silastic Spring-Loaded Silo Group Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure. Patients were assigned to 1 of the 2 groups using the sealed-envelope method. 28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique. 0 None 1 27 2 27 View
Primary Closure of Abdomen Group Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful. Patients were assigned to 1 of the 2 groups using the sealed-envelope method. 27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure. 0 None 1 27 1 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Short Bowel Syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atresia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View