Table.
Toxicity grading scales | Age group | Mild (grade 1) | Moderate (grade 2) | Severe (grade 3) | Life threatening (grade 4) |
---|---|---|---|---|---|
P2-VP8 study - initial | ≥2 and <3 years | 1500-2000 | 900-1499 | <900 | <250 |
P2-VP8 study - revised | ≥6 and <8 weeks | 1000-1300 | 750-999 | 500-749 | <500 |
CLS | Not specified | 1500-2000 | 900-1499 | <900 | – |
DAIDS V1.0 | >7 days | 1000-1300 | 750-999 | 500-749 | <500 |
DAIDS V2.0/V2.1 | >7 days | 800-1000 | 600-799 | 400-599 | <400 |
DMID | 7-60 days | 1200-1800 | 900-1199 | 500-899 | <500 |
DMID | >60 days | 750-1200 | 400-749 | 250-399 | <250 |
FDA | Healthy adult and adolescent | 1500-2000 | 1000-1499 | 500-999 | <500 |
CTCAE 5.0 | Not specified | 1500-<LLN | 1000-1499 | 500-999 | <500 |
CLS, Clinical Laboratory Services, Johannesburg, South Africa; CTCAE, Common Terminology Criteria for Adverse Events Version 5.0 Nov 2017 (https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf); DAIDS, DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; V1.0 Dec 2004, clarification Aug 2009 (https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf); V2.0 – November 2014 (https://rsc.niaid.nih.gov/sites/default/files/daids-ae-grading-table-v2-nov2014.pdf); V2.1 – July 2017 (https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf); DMID, Division of Microbiology and Infectious Diseases Pediatric Toxicity Tables Nov 2007 (https://www.niaid.nih.gov/sites/default/files/dmidpedtox.pdf); FDA, Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007 (https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM091977.pdf); LLN, lower limit of normal.