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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT01304706
Term: Glaucoma surgery
Organ System: Surgical and medical procedures
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA
Notes: #Study eye
Study: NCT01304706
Study Brief: Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 2 2 120 View