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 @ 6:44 PM
Ignite Modification Date: 2025-12-25 @ 4:15 PM
NCT ID: NCT00522457
Term: somnolence
Organ System: Psychiatric disorders
Assessment Type: None
Source Vocabulary: None
Notes: None
Study: NCT00522457
Study Brief: Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 19 View