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 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:45 AM
NCT ID: NCT01198002
Term: Squamous cell carcinoma
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 16.0
Notes: None
Study: NCT01198002
Study Brief: A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 0 0 345 View
EG001 0 0 345 View
EG002 0 0 348 View
EG003 0 0 58 View
EG004 0 0 62 View
EG005 0 0 90 View
EG006 0 0 57 View
EG007 0 0 73 View
EG008 0 0 27 View
EG009 0 0 31 View
EG010 0 0 13 View
EG011 0 0 22 View
EG012 0 0 241 View
EG013 0 0 303 View
EG014 0 0 27 View
EG015 0 0 27 View
EG016 0 0 52 View
EG017 0 0 85 View
EG018 1 1 168 View