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 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT02918318
Term: Ankle Fracture
Organ System: Injury, poisoning and procedural complications
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA Version 22.0
Notes: None
Study: NCT02918318
Study Brief: A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 0 41 View
EG002 None 0 40 View
EG003 None 0 80 View
EG004 None 0 27 View
EG005 None 0 29 View
EG006 None 0 23 View
EG008 None 0 13 View
EG010 None 0 17 View
EG011 None 0 27 View
EG012 None 0 48 View
EG013 None 0 48 View
EG001 None 0 41 View
EG007 None 1 53 View
EG009 None 0 11 View