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: 2025-12-24 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01147666
Term: Sepsis
Organ System: Infections and infestations
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 10.1
Notes: None
Study: NCT01147666
Study Brief: Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 0 12 View
EG001 None 0 12 View
EG002 None 0 12 View
EG003 None 0 12 View
EG004 None 0 12 View
EG005 None 0 12 View
EG006 None 1 12 View
EG007 None 0 12 View
EG008 None 0 2 View
EG009 None 0 10 View
EG010 None 0 36 View
EG011 None 0 4 View
EG012 None 0 5 View
EG013 None 0 4 View
EG014 None 0 4 View