" /> Safety and Tolerability - CISMeF





Preferred Label : Safety and Tolerability;

NCIt definition : The aspects of medical product evaluation associated with risk to the subject/patient and the degree to which overt adverse effects can be tolerated.;

Alternative definition : CDISC-GLOSS: The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs, and symptoms), and other special safety tests (e.g., ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9];

NCI Metathesaurus CUI : CL540597;

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30/07/2025


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