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: 2025-12-25 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:25 AM
NCT ID: NCT00007020
Term: Respiratory disorder
Organ System: Respiratory, thoracic and mediastinal disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (11.0)
Notes: None
Study: NCT00007020
Study Brief: Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 79 View