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 @ 4:10 AM
Ignite Modification Date: 2025-12-26 @ 3:08 AM
NCT ID: NCT00676520
Term: Reproductive system and breast disorders
Organ System: Reproductive system and breast disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (11.0)
Notes: None
Study: NCT00676520
Study Brief: XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 4 3 4952 View