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 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT01587118
Term: Psychiatric hospitalization
Organ System: Psychiatric disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (10.0)
Notes: One participant was hospitalized on psychiatric unit in the month following study exit while not on asenapine; Unrelated SAE.
Study: NCT01587118
Study Brief: An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 18 View