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 @ 3:31 PM
Ignite Modification Date: 2025-12-25 @ 1:45 PM
NCT ID: NCT02980692
Term: Intraductal proliferative breast lesion
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: None
Study: NCT02980692
Study Brief: Efficacy and Safety Study of SUNPG1623
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 0 0 78 View
EG001 0 0 79 View
EG002 0 0 77 View
EG003 0 0 78 View
EG004 0 0 79 View
EG005 0 0 78 View
EG006 0 0 79 View
EG007 0 0 77 View
EG008 1 1 78 View
EG009 0 0 79 View
EG010 0 0 78 View
EG011 0 0 79 View
EG012 0 0 77 View
EG013 0 0 78 View
EG014 0 0 79 View