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 @ 9:23 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT01079832
Term: Bilirubin (hyperbilirubinemia)
Organ System: Investigations
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: CTCAE (3.0)
Notes: Additional adverse events associated with this hospitalization were: Grade 1 INR (International Normalized Ratio of prothrombin time) Grade 2 Liver dysfunction/failure (clinical)
Study: NCT01079832
Study Brief: Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 50 View