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)