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. 2022 Sep 14;23:775. doi: 10.1186/s13063-022-06493-5

Table 5.

Severity grading for unsolicited adverse eventsa

Description
Grade 1 Mild No interference with activity and no or minimal intervention1 required
Grade 2 Moderate Some interference with activity or requires more than minimal intervention
Grade 3 Severe Prevents daily activity and required significant medical intervention
Grade 4 Life-threatening Life-threatening consequences requiring urgent medical intervention
Grade 5 Death Results in death

aAdapted from Cancer Therapy Evaluation Program, Common Terminology Criteria for AEs, version 3.0, DCTD, NCI, NIH, DHHS March 31, 2003, published on August 9, 2006

1One or two doses of antipyretic or simple analgesic medication or local topical treatment

HHS Vulnerability Disclosure