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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:04 PM
NCT ID: NCT00847535
Term: Biopsy to treatment: Drug hypersensitiviy
Organ System: Immune system disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 15.0
Notes: None
Study: NCT00847535
Study Brief: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 66 View