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: 2025-12-25 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:17 AM
NCT ID: NCT00716820
Term: Enterocolonic fistula
Organ System: Gastrointestinal disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 18.0
Notes: None
Study: NCT00716820
Study Brief: Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 472 View