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 @ 2:45 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT01628159
Term: Pseudoaneurysm
Organ System: Vascular disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: Internal System
Notes: Access site: Pseudoaneurysm
Study: NCT01628159
Study Brief: LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 657 View