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 @ 5:34 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT03750968
Term: Multiple congenital abnormalities
Organ System: Congenital, familial and genetic disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: One infant in the carotenoid group was born prematurely with congenital abnormalities. This adverse event originated before study enrollment and was therefore unrelated to the study intervention.
Study: NCT03750968
Study Brief: Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 24 View
EG001 0 0 23 View