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 @ 2:37 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT01922934
Term: Death occurring after being lost to follow up for a year on meal replacement tool
Organ System: General disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: After being lost-to-follow-up for 1 year after 1 visit where meal replacements were dispensed, study staff learned tyring to follow up for final feedback visit that patient had passed away. The PI, IRB, and Sponsor determined his death was unrelated
Study: NCT01922934
Study Brief: A Toolbox Approach to Obesity Treatment in Primary Care
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 140 View