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 @ 7:21 PM
Ignite Modification Date: 2025-12-25 @ 5:00 PM
NCT ID: NCT01925703
Term: Clinical Deterioration
Organ System: General disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: Patient was withdrawn from study after two of the four study drug doses were administered at the discretion of the treating physician. Reason for withdrawal was clinical deterioration secondary to hypovolemia and aggressive vasodilator titration.
Study: NCT01925703
Study Brief: Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 13 View