N2

ki — ZQ/2A

kik2

ki + k2

k2 + Zq/2A

kik2

ki + ZQ/2A

kik2

ki + k2

k2 - Zq/2a

kik2

ki + k2

Example: The Committee on Safety of Medicines (CSM) (1990) has published complete data on post-marketing surveillance of non-steroidal anti-inflamatory drugs (NSAIDs) in the United Kingdom, for two drugs launched approximately at the same date, piroxicam (1980) and diclofenac (1979). The number of serious gastrointestinal reactions reported to the CSM during the same time interval (five years) was 538 for 9.16 million prescriptions for piroxicam versus 68 for 3.25 million prescriptions for diclofenac. The RR estimated from these data is U x [(538 x 3.25)/(68 x 9.16)] = 2.81 U and the corresponding 95% two-sided CI is calculated as:

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