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 @ 12:19 PM
Ignite Modification Date: 2025-12-26 @ 12:19 PM
NCT ID: NCT02947100
Term: Mondor's disease
Organ System: Reproductive system and breast disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: Subject developed Mondor's disease one month after study drug was stopped due to study suspension. Admitted to hospital for one night of observation, resolved without treatment. The SAE was deemed unrelated to study medication.
Study: NCT02947100
Study Brief: Omega-3 Fatty Acids in Sickle Cell Disease
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 1 View