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 @ 8:00 PM
Ignite Modification Date: 2025-12-25 @ 5:34 PM
NCT ID: NCT00643604
Term: Dehydration
Organ System: Metabolism and nutrition disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA
Notes: Subject was hospitalized for abdominal pain, nausea, vomiting and dehydration and subsequently died. The investigator assessed the relationship to the study drug as not reasonably attributable to the study drug.
Study: NCT00643604
Study Brief: Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 7 View