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 @ 6:41 PM
Ignite Modification Date: 2025-12-25 @ 4:12 PM
NCT ID: NCT01891357
Term: Cholecystitis
Organ System: Gastrointestinal disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: NCI-CTCAE version 4.
Notes: Cholecystitis
Study: NCT01891357
Study Brief: Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 2 1 61 View