Measurements And Events

Some endpoints assess events, while others provide a measurement of an outcome. Events occur at a specific point in time and their assessment is binary, i.e., either the event has occurred or it has not. Examples of events are death, stroke, cure of infection, progression to AIDS, myocardial infarction, or a flare of asthma. In contrast, measurements have several or many potential values that may change over time. Examples of measurements include blood pressure, strength, weight, CD4+ cell count, tumor size, quality of life scored on a standard scale, and visual acuity. Several factors may affect the decision to use a measurement-based or an event-based endpoint. Measurements can detect a broad range of change in the outcome measure in each patient; therefore, measurement-based endpoints will often be more sensitive and yield greater power than event-based endpoints. Measurements, however, may detect very small changes, and therefore may raise more questions about clinical meaningfulness.

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