Serious Event

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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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT00048893
Term: Febrile neutropenia
Organ System: Infections and infestations
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: CTCAE (4.0)
Notes: (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0x10e9/L, fever\>=38.5 degrees C)
Study: NCT00048893
Study Brief: Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 13 8 37 View