SAEs: Expectedness

The assessment of whether or not an SAE is an expected consequence of receiving the intervention will be provided by one of the co-Chief Investigators (or Clinical Reviewer Delegate), it will not be provided by the Investigator responsible for the care of the participant.

In this patient population, acute illness resulting in hospitalisation, new medical problems and deterioration of existing medical problems are expected. PACE POCT is a safe test to undergo and we do not envisage any SAEs resulting from the test itself.