Schulungen, praktische Hilfen

Institut für Arzneimittelsicherheit

Gutachten, Klinische Studien, Statistik und Epidemiologie

SHORT GLOSSARY

Adverse Event

AE – Every adverse event occurring in a clinical study, not necessarily causal related with the administration/intake of a drug.

Adverse (Drug) Reaction

A(D)R – Every adverse effect with at least a suspicion on a causal involvement of a drug.

Unexpected Adverse Reaction

UAR – Every adverse reaction with at least a suspicion on a causal relationship of a drug and which is not yet reported so far or which severity is exceeding that of a known reaction significantly.

Serious Adverse Event

SAE – Every adverse, serious event occurring in a clinical study, not necessarily causal related with the administration/intake of a drug.

Serious Adverse Reaction

SAR – Every adverse and serious reaction with at least a suspicion on a causal involvement of a drug.

Suspected Unexpected Serious Adverse Reaction

SUSAR – Every adverse and serious reaction with at least a suspicion on a causal relationship of a drug and which is not yet reported so far or which severity is exceeding that of a known reaction significantly.

Quelle: Peter M. Kaiser, Gibt es jetzt nur noch AE, keine „Nebenwirkungen“ mehr? Was ist relevant für die Arzneimittelsicherheit? Deutsche Zeitschrift für Klinische Forschung, Heft 1/2 (2006) www.dzkf.de

Mengentheoretische Darstellung (als Powerpoint downladen)

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