Table 1.

Terms and their definitions used to quantify risk.

Relative risk is based on a comparison of the risk in GH treated patients, or a subset of such patients, vs the risk in an untreated comparison group or population
The standardized mortality ratio (SMR) is the ratio of observed cases among GH treated patients, or a subset of such patients, to the expected number of cases based upon the general population rate
The absolute risk is the calculated rate, generally expressed as number of cases per 1000, 10 000, or 100 000 person years
The number-needed-to-harm is defined as the number of patients needed to be exposed to a risk factor over a specified period to cause harm in one patient