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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT00750893
Term: Cytomegalovirus Gastrointestinal Infection
Organ System: Gastrointestinal disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA; WHO-ART
Notes: "Secondary items - events" SOC as per WHO-ART dictionary.
Study: NCT00750893
Study Brief: Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 3111 View