Serious Event

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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: Down syndrome
Organ System: Congenital, familial and genetic disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: One infant in the carotenoid group was diagnosed with down syndrome at six weeks of age, which was confirmed by genetic testing. 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