Serious Event

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 @ 10:02 PM
Ignite Modification Date: 2025-12-25 @ 7:39 PM
NCT ID: NCT01238835
Term: Bleeding - Trauma
Organ System: Injury, poisoning and procedural complications
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (23.0)
Notes: None
Study: NCT01238835
Study Brief: PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 5 5 218 View