Routine Analysis Of Data

Standard reports are prepared as follows for each drug studied:

• Reporting rates. For each drug monitored, rates per 1000 patients are calculated for the numbers of (1) reports, (2) all events, (3) reactions and (4) incidents, respectively, in total and by gender. If PEM is not conducted nation-wide, rates are also calculated by spontaneous and PEM regions. The overall reaction and incident rates are useful for comparing sub-groups and for between-drug comparisons, but in contrast to rates for individual events, do not provide a specific measure of risk because some patients have several events associated with the one report.

• Age and gender distribution. This is presented in tabular format with numbers and percentages and as a histogram.

• Regional distribution. This analysis demonstrates any differences in prescribing of the drug between administrative regions.

• Dose distribution. This provides a distribution table for the different common doses used at the time of the first and latest prescription. Dose analyses on latest prescriptions are performed only if there have been more than three prescriptions in order to assess the doses being prescribed at a time when treatment is likely to be stabilised. The mean doses are calculated for the first, latest and all prescriptions.

• Duration of exposure. The total exposure of the cohort is calculated in patient-years. The mean duration of exposure per patient is also calculated. This may be in terms of completed courses of therapy.

• Indications for treatment. These are presented for the whole cohort as numbers and percentages.

• Reaction rates by dose. The data are sorted by the standard dosages used and the overall reaction rates are presented for each dosage level.

• Profile of adverse events. This provides a table and histogram showing numbers and rates by system/organ class of reactions, incidents and all events, respectively.

• Reasons for cessation of therapy. This shows the frequency, proportion of total withdrawals and the rate for each category recorded (see above).

• Most frequent events. These are shown (usually the top 10) with numbers and rates together with the numbers and rates of withdrawals and deaths for these events.

• Reactions with rates. This provides a listing of all events assessed as reactions, showing the percentage of each within each system/organ class, the percentage of each reaction amongst all reports and the rate of occurrence of each reaction. These are sorted into clinical groupings within each class.

• Table of all events. This listing of all the individual events is presented by system/organ class and within the classes the events are sorted into clinically related groupings. This allows a clinically orientated visual assessment of the events reported and is useful in signal detection. It shows, for every event, the age and gender of the patient, the dose, the duration to onset and the relationship that was established at the time of the review of the report. It also shows deaths and withdrawals. The individual events can be cross referenced with the table of reports, which presents the events in the context of the whole reaction.

• Table of reports. This is a listing by report and shows all the events associated with each report, e.g. one report describing eosinophilia, arthral-gia, malaise and rash with omeprazole, thus presenting the events in the context of the whole reaction. The age and gender for each patient is shown along with the dose, severity, relationship and outcome of each event.

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