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 @ 4:38 PM
Ignite Modification Date: 2025-12-25 @ 2:28 PM
NCT ID: NCT01763866
Term: Bladder neoplasm
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 16.1
Notes: None
Study: NCT01763866
Study Brief: LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 0 56 View
EG001 None 0 55 View
EG002 None 0 56 View
EG003 None 0 55 View
EG004 None 0 110 View
EG005 None 0 110 View
EG006 None 0 55 View
EG007 None 0 55 View
EG008 None 1 56 View
EG009 None 0 54 View
EG010 None 0 109 View
EG011 None 0 110 View
EG012 None 0 58 View
EG013 None 0 57 View
EG014 None 0 113 View
EG015 None 0 115 View
EG016 None 0 56 View
EG017 None 0 55 View
EG018 None 0 111 View
EG019 None 0 112 View
EG020 None 0 56 View
EG021 None 0 55 View
EG022 None 0 112 View
EG023 None 0 115 View