Toxicity criteria in oncology/hematology clinical trials

To standardize the reporting of adverse reactions in clinical trials, NCI has developed Common Terminology Criteria for Adverse Events (NCI-CTCAE). The NCI-CTCAE were most recently updated in June 2010 (version 4.03). Clinical trials begun earlier than this date may use earlier versions of the NCI-CTCAE when reporting adverse reactions.

According to the NCI-CTCAE, adverse reactions are reported by grade (level of severity) on a scale of 1 to 5. Generally, the descriptions follow the guidelines below.

Table 8. NCI-CTCAE definitions of severity for adverse reactions19

Grade Degree of severity
1 Mild, with no or mild symptoms; no interventions required
2 Moderate; minimal intervention indicated; some limitation of activities
3 Severe but not life-threatening; hospitalization required; limitation of patient's ability to care for him/herself
4 Life-threatening; urgent intervention required
5 Death related to adverse event

Common adverse reactions by grade

The following table shows NCI-CTCAE grades for some adverse reactions commonly observed in clinical trials in oncology/hematology. This list is not all-inclusive; please consult the NCI-CTCAE for a full list of adverse reaction criteria.

Adverse reaction Grade 1 Grade 2 Grade 3 Grade 4 Grade 5
Anemia Hb <LLN to 10.0 g/dL Hb <10.0 g/dL to 8.0 g/dL Hb <8.0 g/dL; transfusion indicated Life-threatening consequences; urgent intervention indicated Death
Neutropenia Neutrophils <LLN to 1,500/mm3 Neutrophils <1,500 to 1,000/mm3 Neutrophils <1,000 to 500/mm3 Neutrophils <500/mm3 N/A
Thrombocytopenia Platelets <LLN to 75,000/mm3 <75,000 to 50,000/mm3 <50,000 to 25,000/mm3 <25,000/mm3 N/A
Hepatic failure N/A N/A Asterixis; mild encephalopathy; limitation of self-care Moderate to severe encephalopathy; coma; life- threatening consequences Death
Creatinine increase >1 to 1.5× baseline; >ULN to 1.5× ULN >1.5 to 3.0× baseline; >1.5 to 3.0× ULN >3.0× baseline; >3.0 to 6.0× ULN >6.0× ULN N/A
Fatigue Relieved by rest Not relieved by rest, limiting ADL Not relieved by rest; limits self-care N/A N/A
Febrile neutropenia N/A N/A ANC <1,000/mm3 with single temperature reading >38.3°C (101.0°F) or sustained temperature ≥38.0°C (100.4°F) for >1 hour Life-threatening consequences; urgent intervention indicated Death
Fever 38.0°C to 39.0°C (100.4°F to 102.2°F) >39.0°C to 40.0°C (102.3°F to 104.0°F) >40.0°C (>104.0°F), lasting ≤24 hours >40.0°C (>104.0°F), lasting >24 hours Death
Infections and infestations Asymptomatic or mild symptoms; observations only; intervention not indicated Moderate symptoms; minimal intervention indicated; limiting instrumental ADL Severe or medically significant but not immediately life-threatening; hospitalization indicated; limiting self-care ADL Life-threatening consequences; urgent intervention indicated Death
Infusion reactions Mild, transient reaction; interruption/intervention not indicated Interruption indicated, but responds promptly to symptomatic treatment; prophylactic medications indicated Prolonged (not rapidly responsive to treatment and/or infusion interruption); recurrence of symptoms following initial improvement; hospitalization indicated Life-threatening consequences; urgent intervention indicated Death

LLN=lower limit of normal; ULN=upper limit of normal; ANC=absolute neutrophil count; ADL=activities of daily living.

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