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: 2025-12-25 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT04443218
Term: Readmission - Cardiac (not Heart Failure)
Organ System: Cardiac disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: STS/ACC TVT Registry
Notes: None
Study: NCT04443218
Study Brief: Edwards PASCAL Transcatheter Valve Repair System Registry
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 30 26 220 View