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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.

 

Arzneimittelsicherheit

Source: 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

 
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