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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT04858802
Term: Loss of balance
Organ System: Nervous system disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 24.0
Notes: Participant reported losing his balance while moving machinery down a ramp, resulting in a fall and bruising to his ribs, knee, and lower back. Loss of balance cannot be localized to a side, so each instance is represented in both arms.
Study: NCT04858802
Study Brief: A Clinical Evaluation of PROPELĀ® Contour Sinus Implant
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG001 None 1 80 View
EG000 None 1 80 View