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 @ 9:34 PM
Ignite Modification Date: 2025-12-25 @ 7:18 PM
NCT ID: NCT02217332
Term: biliary dyskinesia
Organ System: Metabolism and nutrition disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 16.0
Notes: The investigator and the sponsor both assessed the SAE of cholecystitis as not related to the study drug.
Study: NCT02217332
Study Brief: Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 20 View