Adverse events trend analysis

In-process assays provide data for the statistical analysis of trends for yield/quality improvement or warnings of potential adverse events. 

As of the interim analysis, there have been no adverse events reported, nor have there been any apparent trends in changes in vital signs. rAHF-PFM appears to be safe and well tolerated. 

Some databases have a life of their own because of organizational stove piping. Typically, time-based trending analysis of types of adverse events/causative factors is too general to identify cause and effect relationships. Without the development of normalized measurements, changes in mission and/or work load affect safety performance far more than do changes associated with the quality of safety management. 

Active evaluation of the competitive and collaborative environment, and identification of parmers with whom to learn and share best practices in clinical care Analysis of adverse events, and identification of trends across events Establishment of rewards and recognition for reporting errors and for safety-driven decision making... 

In a meta-analysis of randomized controlled studies of dronedarone and amiodarone for prevention of recurrent atrial fibrillation, four placebo-controlled trials of dronedarone, four placebo-controlled trials of amiodarone, and one trial of dronedarone versus amiodarone were compared [61 ]. Amiodarone was superior to dronedarone in preventing recurrent atrial fibrillation, but there was a trend towards greater all-cause mortality (OR = 1.61 95% Cl = 0.97, 2.68) and more overall adverse events requiring drug withdrawal with amiodarone than with dronedarone (OR = 1.81 95% Cl = 1.33, 2.46). Among adverse reactions, thyroid toxicity was more frequent with amiodarone (7.5% versus 4.0%) whereas increased serum creatinine was more frequent with dronedarone (4.0% versus 0%). For every 1000 patients treated with dronedarone instead of amiodarone, the authors estimated that there were about... 

Trend analysis - this can be achieved in a number of ways. As a minimum a paper-based system can be used where the workforce is smaii and adverse events are few. it is normai for SMEs and iarger organisations to employ an electronic system for recording the necessary data. Whichever system is used it must be able to provide a management overview of the event experience and enable an analysis of event trends. 

Systematic reviews In a meta-analysis of 25 randomized trials and 4 matched studies of the effects of tranexamic acid in 5411 and 5977 patients respectively, the total intravenous dose of tranexamic add varied from 1 to 20 g, given over 20 minutes to 12 hours [67 ]. Compared with placebo, tranexamic acid was assodated with less blood loss and reduced rates of re-operation for bleeding, transfusion of packed erythrocytes, and use of hemostatic blood prcxiuds. There was a non-significant trend to postoperative adverse neurological events, but operative mortahty was reduced in patients who received tranexamic acid compared with no treatment. 

---