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 @ 12:17 AM
Ignite Modification Date: 2025-12-25 @ 10:20 PM
NCT ID: NCT01998958
Term: Confusional State
Organ System: Psychiatric disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA Version 18.0
Notes: None
Study: NCT01998958
Study Brief: A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 0 1 View
EG001 None 0 3 View
EG002 None 0 23 View
EG003 None 0 5 View
EG004 None 0 8 View
EG005 None 0 12 View
EG006 None 0 5 View
EG007 None 0 11 View
EG008 None 0 8 View
EG009 None 0 16 View
EG010 None 0 12 View
EG011 None 0 23 View
EG012 None 0 27 View
EG013 None 0 46 View
EG014 None 0 1 View
EG015 None 0 4 View
EG016 None 1 12 View
EG017 None 0 39 View
EG018 None 0 42 View
EG019 None None 11 View
EG020 None None 20 View
EG021 None None 12 View
EG022 None None 17 View