An AE is any negative medical occurrence that is associated in time with drug therapy. An ADR is an AE attributed to a drug. A distinction should also be made between risk & harm. Risk refers to the probability of developing an outcome, regardless of severity. Harm is a more descriptive term & includes not only frequency of occurrence but also severity & duration. The ICH, distinguished serious (outcome of ADR) from severe (grading of the degree of any ADR) reactions Ex: severe pruritus is not a serious ADR. Because serious denotes that a reaction is life-threatening.
This topic covers: Measurement of risk, attributable risk and relative risk, time-risk relationship and odds ratio.