220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

187unblinded study syn. open s.; study where both physician and patientknow the treatment; → see design, open study.uncontrolled study Study without control group (automaticallyalso not blinded), e.g., as pilot study for collecting very first experiencesor as open extension or follow-up study of a controlled clinicalstudy; → see also design.underweight → see cachexia, weight.unexpected adverse event ICH: “… is one, the nature or severity ofwhich is not consistent with information in the relevant sourcedocument(s). Until source documents are amended, expeditedreporting is required for additional occurrences of the reaction”.unlisted adverse drug reaction ICH: “An adverse reaction, thenature or severity of which is not consistent with the informationincluded in the Company Core Safety Information; → see alsolisted adverse drug reaction.utilisation study → see pharmacoepidemiology.utility measurement Economic perspective of quality of life measurements;u. reflects here the degree of satisfaction or amountof well-being of a patient with a specific treatment, independentof what the treatment actually costs or whether it produces anyfinancial gain; u. is standardized relative to states of health andprovides a synthetic assessment of quality of life; it takes intoaccount patient’s preferences which are translated into monetaryterms esp. costs (for visits, hospitalizations, lab tests, additionaldrugs or treatments, days out of work; different rating methods canbe used to obtain utility values (e.g. time trade-off, standardgamble, well-being scale); → see also cost/utility analysis,quality-adjusted life-years.uti