1.3. Safety – What Possible Side Effects Did The Medicine Have?
Participants in a clinical trial
are asked to report to the investigator
(or trial staff) if anything undesired has happened. The ‘adverse event
’ information collected in this way is analysed to give an insight into possible side effects of the medicine, i.e. a possible causal relationship
between the trial medication and the observed adverse event
. Particular attention is paid to ‘serious’ adverse events – those which are life-threatening or associated with death, hospitalisation or birth abnormalities.