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 @ 12:36 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT00709761
Term: Renal failure
Organ System: Renal and urinary disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (20.1)
Notes: None
Study: NCT00709761
Study Brief: Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 60 View