This event qualifies as aSerious Adverse Event (SAE)because itresulted in a prolonged hospitalization, even though the episode itself was mild.
According toICH E2AandGCDMP (Chapter: Safety Data Handling and Reconciliation), an adverse event is considered“serious”if it results in any of the following outcomes:
Death,
Life-threatening situation,
Hospitalization or prolongation of existing hospitalization,
Persistent or significant disability/incapacity, or
Congenital anomaly/birth defect.
The severity (mild, moderate, severe) describesintensity, while seriousness describesregulatory significance and medical outcome. Thus, a mild tachycardia episode leading to extended hospital stay meets theregulatory definition of an SAE.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Safety Data Handling and Reconciliation, Section 5.2 – Definition and Classification of Serious Adverse Events
ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Section II – Seriousness Criteria
FDA 21 CFR 312.32 – IND Safety Reporting: Serious Adverse Event Definitions
