RE: SP26 Jan 2022 15:32
So there are five main levels of adverse events when running clinical trials - Adverse Events (AEs), Adverse Reactions (ARs), Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
AEs - are unfavourable and unintended signs, including abnormal results, symptoms or disease associated with treatment. These are recorded in case report forms and in the patient notes.
AEs can be classified as serious or non-serious, expected or unexpected, study related, possibly study related or not study related. Minor AEs are reported in bulk to the sponsor and generally are noted and submitted later but are reviewed at regular stages through a trial.
AEs are generally reported in grades
1 - Mild AE (asymptomatic or mild symptoms, no intervention required)
2 - Moderate AE (minimal, local or non-invasive intervention may be needed)
3 - Severe AE (not immediately life threatening, but medical intervention required)
4 - Life threatening/disabling AE (urgent intervention required)
5 - Death related to AE
Throughout a trial generally you will have a reasonable amount of Grade 1 and Grade 2 AEs, but these generally include things like 'patient experienced a headache after injection' or 'pain and reddening at site of injection'. Generally clinical trial results often report the number of Grade 3 or Grade 4 adverse events. Depending on the nature of these, a trial may be halted temporarily or stopped all together if severe enough.
ARs - are adverse events but casually related to the investigational product. So any untoward and unintended response in a subject to an investigational product.
SAEs - are any untoward medical occurrence that at any dose results in death, hospitalisation, prolongation of existing hospitalisation, persistent or significant disability/incapacity or a congenital anomaly or birth defect. These must be reported immediately to the sponsor. Example TGN1412 clinical trial.
SSARs - are any ARs considered consistent with information about the investigational product. These must be reviewed at regular intervals to see if the profile of the investigational medicinal product has changed.
SUSARs - are any events suspected to be caused by the trial drug, but which are not consistent with information about the product. (These are the most serious and are subjected to expedited reporting). An example of this was the SUSAR which occurred with the AZ Covid-19 vaccine resulting in temporary pause of the trial.
So when SCLP say no safety concerns - read this as none of the following:
- AEs - Grade 3, 4 or 5
- ARs
- SAEs
- SSARs
- SUSARs.
Hope that helps. It's quite a complex part of clinical trials and have many reporting lines with how quick things need reporting and to who. Hence for every clinical trial you have a clinical trials unit who deals on nearly a 24/7 basis with the appropriate reporting and actions.
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