SAEs/SARs/Outcome events

Q: For the SARs, given the half-lives of the DOAC medications, at what time point following the commencement of the DOAC would you consider a bleed not to be a SAR?  For example, if a patient was commenced on DOAC within 96 hours post event but had a bleed at 8 days would this be a SAR or just an outcome event? A: You will need to first assess if the event AE is “serious” in accordance to the definition. If so, next step is to check with your PI (or delegated staff) if he/she thinks it is related to the early administration.

• If YES, it’s an SAR, you will need to complete the paper SAR form, and email to us via an encrypted email

• If NO, it’s an SAE, then you just need to complete the “SAE Unrelated to study intervention log”

• NB: PLEASE CHECK IF ANY SAEs/SARs THE PATIENT EXPERIENCES IS ALSO AN OUTCOME EVENT (SEE LIST BELOW AND PROTOCOL FOR DEFINITIONS). IF SO, YOU WILL NEED TO COMPLETE THE RELEVANT CRF IN ADDITION

1.       Extracranial bleeding

2.       Recurrent ischaemic stroke

3.       Symptomatic intracranial haemorrhage (sICH)

4.       Systemic embolism

5.       Venous thrombosis

6.       Vascular death