Serious Event

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Serious Event

Serious Adverse Events (SAEs) are adverse events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or are congenital anomalies/birth defects. Each serious event is categorized by term, organ system, assessment type, and source vocabulary to provide standardized reporting across clinical trials.

Serious Event path is as follows:

Study -> Results Section -> Adverse Events Module -> Serious Event

Study -> Results Section -> Adverse Events Module -> Serious Event -> Serious Event Stats

Serious Event

Ignite Creation Date: 2025-12-24 @ 1:12 PM
Ignite Modification Date: 2025-12-25 @ 12:23 PM
NCT ID: NCT04773795
Term: Mild Gastric perforation
Organ System: Surgical and medical procedures
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: due to human error the physician didn't pull wire A to release the corset wire prior to system retrieval, as a result of the force exerted by the physician a part of the Bougie broke, also a gastric perforation was suspected
Study: NCT04773795
Study Brief: Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 45 View