What defines a serious adverse event? Serious Adverse Events. Serious Adverse Events includeadverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a...
Define Serious AE. means any untoward medical occurrence that at any dose: results in death; is life-threatening (defined as an event in which the subject or patient was at risk of death at the time of the event; it does not refer to an event which hypot
Serious Adverse Event means any adverse event that led to any of the following: Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on ...
Equipment or machinery failure:In case of an equipment failure, it can lead to new hazards, such as overflows or pipe leakages. Failure of sensitive equipment, such as mixing valves or pressure regulators could cause serious property damage or increase the risk of injury to workers on-site. ...
Public relations embraces a serious element of theethicalcounselingand sociological education of the client. One of the great American practitioners,Earl Newsom, would force his carefully selected clients’ attention to the 19th-century classicThe Crowd(1896;La Psychologie des foules,1895), by the Fre...
An Adverse Event of Special Interest (AESI) (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate. It is anticipated that most...
serious adverse event EBMAny untoward medical event attributed to a therapeutic agent at any dose, which: results in death; is life threatening; requires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability/incapacity; or causes a congenital...
See also:adverse event. Farlex Partner Medical Dictionary © Farlex 2012 adverse drug reaction Any noxious and unintended response associated with the use of a drug in humans. Adverse Drug Reaction Any noxious, undesired, or unintended response to a therapeutic agent, which may be expected or un...
Death, cardiac arrest, and unplanned admissions to an intensive care unit are probably the most serious among the adverse events. Most of these events have their genesis in general wards; they are not sudden or unpredictable, because they are usually preceded by signs of clinical instability. ...
9 RegisterLog in Sign up with one click: Facebook Twitter Google Share on Facebook Acronyms treatment-emergent adverse event An event that first appears during treatment, which was absent before or which worsens relative to the pre-treatment state. ...