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 @ 7:41 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT05619003
Term: Death
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: Patient admitted with end stage cirrhosis or cancer of the liver. Event assessed as not related to the investigational device by the investigator
Study: NCT05619003
Study Brief: Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 67 View