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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT00427895
Term: Bipolar disorder
Organ System: Psychiatric disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA
Notes: None
Study: NCT00427895
Study Brief: Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 0 417 View
EG003 None 1 414 View
EG005 None 0 403 View
EG008 None 0 108 View
EG010 None 0 189 View
EG013 None 0 214 View
EG015 None 0 899 View
EG001 None 0 417 View
EG002 None 0 414 View
EG004 None 0 403 View
EG006 None 0 108 View
EG007 None 0 108 View
EG009 None 0 108 View
EG011 None 0 189 View
EG012 None 0 214 View
EG014 None 0 899 View