Serious Event

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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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT01958294
Term: Hematoma
Organ System: Vascular disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: SAEs were not reviewed by the independent Clinical Events Committee (CEC) because no MI Stroke or Death. Neither of these events was deemed to be related to the study device.
Study: NCT01958294
Study Brief: The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 2 2 12 View