DAIDS Adverse Event Grading Tables | DAIDS Regulatory Support Center (RSC)

DAIDS Adverse Event Grading Tables | DAIDS Regulatory Support Center (RSC)

DAIDS Adverse Event Grading Tables

The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events consists of parameters, or Adverse Events (AEs), with severity grading guidance that are to be used in DAIDS clinical trials for safety data reporting to maintain accuracy and consistency in the evaluation of AEs.

Below are the Grading Tables (Versions 1.0, 2.0 and Corrected v 2.1), ​suggested citations, applicable clarification documents, and additional resources. The protocol will specify which DAIDS Adverse Event Grading Table is applicable.

DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1

Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)pdf

Suggested Citation

U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdfpdf

Clarification Documents for the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events - Corrected Version 2.1 - July 2017

• Grading Table with all Changes Highlightedpdf
• Parameter Level Summary of Changespdf

DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0

Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Eventspdf (Version 2.0 - November 2014)

Suggested Citation

U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0. [November 2014]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daids-ae-grading-table-v2-nov2014.pdfpdf

Clarification Documents for the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events  - Version 2.0 - November 2014

• Grading Table with all Changes Highlightedpdf  
• High Level Summary of Changespdf
• Parameter Level Summary of Changespdf

DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0

Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Eventspdf (Version 1.0 - December 2004 (Clarification dated August 2009))

Suggested Citation

U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. [Updated August 2009]. Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdfpdf

Memo Regarding the Clarification to the Table for Grading Severity of Adult and Pediatric Adverse Eventspdf

Additional Grading Table Resources

• Addendum 1 – Female Genital Grading Table for Use in Microbicide Studiespdf, Version 1.0 – November 2007
• Addendum 2 – Male Genital Grading Table for Use in Microbicide Studiespdf, Version 1.0 – November 2007
• Addendum 3 – Rectal Grading Table for Use in Microbicide Studiespdf(Clarification dated May 2012), Version 1.0 – November 2007 (Clarification dated May 2012)
• Memo Regarding the Clarification to the Rectal Grading Table for Use in Microbicide Studiespdf