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 @ 5:33 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT04798768
Term: Non-cardiovascular
Organ System: Skin and Subcutaneous Tissue Disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (Unspecified)
Notes: None
Study: NCT04798768
Study Brief: Effectiveness of the EMPOWERâ„¢ Modular Pacing System and EMBLEMâ„¢ Subcutaneous ICD to Communicate Antitachycardia Pacing
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 2 2 288 View