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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT03319160
Term: Inappropriate shocks
Organ System: Product Issues
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: Shocked without clinical VT or VF resulting in hospitalization or other medical intervention
Study: NCT03319160
Study Brief: LifeVest Safety and Efficacy in Real Life Settings in France
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 4 4 1157 View