Adverse events (AE) | Any unfavourable or unintended symptom or sign associated with the intervention during the trial. Any AE considered to be of clinical significance by the local chief investigator as causing harm to the participant will be recorded and rated in severity. Data to be recorded: onset, resolution outcome, severity. Causality will be assessed by site investigators and reported as none, unlikely, possible, probable or definite.
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Serious adverse events (SAE) | |
Adverse device events and serious adverse device events | |