2.10. Harms
infection, death, disability
ADVERSE EVENT, EVENT, INFECTION, COMPLICATIONS
Adverse event is defined as illness, disability, death, or infection suspected to be attributed to conducting the study, including unintended physical signs, clinically significant changes in laboratory data, and worsening of symptoms or complications. In the event of harms, the principal investigator or sub-investigator will take appropriate actions to ensure the safety of study participants, including giving treatments and discontinuing administration of the research drugs to study participants.