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 @ 7:13 PM
Ignite Modification Date: 2025-12-25 @ 4:49 PM
NCT ID: NCT01845103
Term: Serious Adverse Event required hospitalization
Organ System: Respiratory, thoracic and mediastinal disorders
Assessment Type: None
Source Vocabulary: None
Notes: It was noted that this serious adverse event was not cardiac, procedural or device related.
Study: NCT01845103
Study Brief: The PEARL 8.0 Post-Approval Study
Serious Event Stats (If Any):

Serious Event Stats

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