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Assessing and Reporting Adverse Events (AEs are defined as any clinical…
Assessing and Reporting Adverse Events (AEs are defined as any clinical event, sign, symptom, or laboratory or other finding that goes in an unwanted direction regardless of whether it is considered treatment-related) (Adequate attention needs to be paid to the assessment, analysis, and reporting of adverse events to permit valid assessment of potential risks of interventions.)
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Determinants of AEs
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Assertainment
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Perhaps the range between the volunteered and the solicited numbers within the individual study groups provides bounds on the true incidence of the adverse event.
Definition
Generally, an investigator will prepare a list of potential adverse events on a study form. They usually are not defined, except by the way investigators define them in their daily practice.
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Dimensions: severity
The severity of subjective symptoms is typically rated as mild, moderate, or severe. However, the clinical relevance of this rating is unclear.
One way of dealing with this dilemma is to consider the number of participants who were taken off the study medication due
to the adverse event, the number who had their dose of the study medication reduced, and those who continued treatment according to protocol in spite of a reported adverse symptoms.
FU length
if a trial lasts for several years, and an adverse event is analyzed simply on the basis of cumulative number of participants suffering from it, the results may not be very informative
Analyzing AE
Type of analysis
Present data by visit: proportion of participants withdrawn, having their dose reduced vs continuing the study intervention, or participants who have their treatment temporarily stopped or reduced
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Report AE
Published reports
Included in the reporting should be descriptions of adverse events with numerical data by treatment group, information related
to the severity of adverse events, and the number of participants withdrawn from their study medications due to adverse events.
Regulatory
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For a death or life-threatening event, the report should be made by fax or telephone within 7 days of notification
Scientific
(d) Laboratory measurements, including X-rays and imaging.
(e) In long-term studies, possible intervention-related reasons participants are hospitalized.
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(b) Reasons participants are on reduced dosage of study medication or on lower
intensity of intervention.
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Identifications of SAEs
observational studies conducted postmarketing contribute more to the identification of harmful drug effects than randomized trials
randomized clinical trials are not optimal for the detection of rare, late, and unexpected SAEs.
Potential solutions
Third, the field of pharmacogenetics holds promise for better identification in the future of patient groups that are more likely to develop SAEs
Fourth, observational studies will always have a role in the identification of SAEs.
Second, when individual trials are inconclusive, the fall-back position is the combination of safety data from multiple trials in a meta-analysis or systematic review
Fifth, other potential solutions are case-control studies and databases.
First, one obvious solution to the problem is the conduct of larger and longer clinical trials in participants who better represent future users of the medication
A clinical trial may, however, suggest that further research on adverse events would be worthwhile.