By the definition of FDA, the "serious" means that one or more of the following outcomes were documented in the report: death (DE), hospitalization (HO), life threatening (LT), disability (DS), congenital anomaly (CA) and/or other (OT) serious outcome.
Adverse events (AEs), referred to as healthcare delivering, have been defined as injuries that are caused by medical management rather than the underlying disease [ 1] and which result in death, life threatening illness, disability at the time of discharge, admission to hospital, or prolongation of hospital stay [ 2– 6].
One woman, Dezere Kieran Stone, wrote: "This site was made for people with life threatening illnesses, disabilities, and families going through hard times.
Myopia was a serious, even a life-threatening disability in the hunter-gatherer era, but in the age of easily accessible effective eyeglasses most of us never even think to conceptualize our myopia as a disability.
Serious adverse events were defined as medical events that are life threatening; result in death; disability or significant loss of function; that cause hospital admission or prolonged hospitalization; a hereditary anomaly; or fetal injury [40].
Severe: fatal or potentially life threatening or causing permanent disability.
Major effects are those that may be life threatening or result in disability or disfigurement.
The classification used for ADRs was as follows [ 6, 10]: Severe: fatal or potentially life threatening or causing permanent disability.
severe: fatal or potentially life threatening or causing permanent disability; moderate: requiring treatment or prolonging stay in hospital or causing interference with normal daily activities; mild: minor reactions that do not require treatment and do not prolong stay in hospital.
Monitoring for serious adverse events was conducted throughout the trial (hospitalization, persistent or significant disability, life threatening events such that failure to intervene could result in hospitalization or death).
Serious adverse events (SAEs) were defined as any adverse event resulting in death, life threatening, requiring hospitalization, resulting in disability or incapacity or congenital anomaly or birth defect, or any other event which required intervention to prevent such outcomes.
