Definition of adverse events

Serious adverse events

We will record any adverse event listed below, occurring in the period between the date of providing informed consent and day 14, irrespective of the presence or absence of a causal relationship. Also, we will promptly report any occurrence to the head of the research institute via the reporting division of the hospital within 7 days after the serious adverse event is first noticed.

Serious adverse events:

Resulting in death

Being life-threatening

Requiring inpatient hospitalization or prolongation of existing hospitalization

Resulting in persistent or significant disability/incapacity

Resulting in congenital anomaly

Other adverse events

The therapeutic devices that will be used in this study have already been approved and are routinely used in the clinical setting. Thus, we will not record non-serious adverse events.

We will use the designated case report form to record case information. We will register the case information digitally, with the principal investigator assigning the case number. After registration, the principal investigator and an analyst will analyze individual cases. They will pass the analysis report to the planning and strategy manager.