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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01449266
Term: Dialysis device insertion
Organ System: Surgical and medical procedures
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (15.0)
Notes: This adverse event was considered as not related to the DotaremĀ® injection.
Study: NCT01449266
Study Brief: Safety and Dialysability of DotaremĀ® in Dialysed Patients
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 10 View