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 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT02045433
Term: Diarrhea
Organ System: Gastrointestinal disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: CTCAE (4.0)
Notes: 1 patient developed grade 2 rectal bleeding. Of the grade 3 toxicities, 1 patient had grade 3 diarrhea consisting of greater than 8 stools over baseline per day which occurred 32 days after treatment and lasted two days.
Study: NCT02045433
Study Brief: Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 16 1 16 View