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References in periodicals archive ?
One significant adverse event was a protocol deviation in which 1 patient received an incorrect dose of IV sodium fluorescein (500 mg) instead of the recommended 25-mg dose.
He studied Significant Adverse Event Reviews on NHS Ayrshire & Arran's website following the deaths of three babies and serious injuries to four others.
Those with newly diagnosed diabetes were 43% more likely to die and 18% more likely to have a significant adverse event than were those without diabetes, Dr.
While clinical results of stenting procedures have steadily improved, approximately 30% of individuals undergoing stenting experience a significant adverse event such as peri-stenting myocardial infarction, post-procedure complications from the stented site, or new coronary events at non-stented sites.
The most significant adverse event identified in these studies was diarrhoea, which was mostly either tolerable or could be controlled by medication.
Auscultation remains the earliest and simplest way to identify this problem intra-operatively before any significant adverse event occurs.
He added: "The Significant Adverse Event Reports are very detailed and contain a high level of personal patient information.
Gow said: "NHS Ayrshire & Arran is conducting a significant adverse event review into a recent incident within University Hospital Ayr where standard procedures were not followed.
Such narratives are required for describing each clinically significant adverse event, and certainly any serious adverse event or events that led to patient death.
The one significant adverse event was a case of biopsy-confirmed leukocyto-clastic vasculitis occurring 9 days after a patient received a first 300-mg injection of 553.
Of the 62 patients, 35% (22 patients) had at least one clinically significant adverse event. The most common were persistent drooling (six), coughing (five), throat discomfort or spasms (four), and dysphagia (three).
"Physicians and the public need to be aware of the potential for this significant adverse event so that preventive measures and potential therapy can be considered," they said.
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