re: Pfizer data release. 1223 reported fatalities during 3-month period, out of 42K reports

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Because many external factors influence whether or not an AE is reported, the spontaneous reporting system yields reporting proportions not incidence rates. As a result, it is generally not appropriate to make between-drug comparisons using these proportions; the spontaneous reporting system should be used for signal detection rather than hypothesis testing

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An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AE was caused by the drug; rather, the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication.

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