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: 2025-12-25 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT00467818
Term: Recurrence of mood disorder in one participant
Organ System: Psychiatric disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: One subject had a recurrence of a psychiatric issue ( although might be unrelated to the intake of the placebo which he was on) which lead to hospitalization and discontinuation of taking the placebo and subsequent withdrawal from the study.
Study: NCT00467818
Study Brief: Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 0 0 9 View
EG001 1 1 8 View