Grade 1: minimal skin changes or dermatitis (e.g. erythema) without pain
Grade 2: skin changes (e.g. peeling, blisters, bleeding, oedema) or pain, not interfering with function
Grade 3: ulcerative dermatitis or skin changes with pain interfering with function.
Grade 0 No Adverse Event
▫ Sign/symptom within normal limits
Grade 1 Mild Adverse Event (any of the following)
▫ Minor
▫ Mild symptoms and intervention not indicated
▫ Non-prescription intervention indicated
▫ No specific medical intervention
▫ Asymptomatic laboratory finding only
▫ Radiographic finding only
▫ Marginal clinical relevance
Grade 2 Moderate Adverse Event (any of the following)
▫ Intervention indicated
▫ Minimal, local, noninvasive intervention (e.g. packing, cautery)
▫ Limiting instrumental ADL (e.g., shopping; laundry; transportation; conduct finances)
Grade 3 Severe Adverse Event (any of the following)
▫ Medically significant but not life-threatening
▫ Inpatient or prolongation of hospitalization indicated
▫ Important medical event that does not result in hospitalization but may jeopardize the
patient or may require intervention either
▫ to prevent hospitalization or
▫ to prevent the AE from becoming life-threatening or potentially resulting in death
▫ Disabling - results in persistent or significant disability or incapacity
▫ Limiting self care ADL (e.g., getting in and out of bed; dressing; eating; getting around inside;
bathing; using the toilet)
Grade 4 Life-threatening Adverse Event (any of the following)
▫ Life-threatening consequences
▫ Urgent intervention indicated
▫ Urgent operative intervention indicated
▫ Patient is at risk of death at the time of the event if immediate intervention is not
undertaken
Grade 5 Fatal Adverse Event
▫ Death
Grade 2: skin changes (e.g. peeling, blisters, bleeding, oedema) or pain, not interfering with function
Grade 3: ulcerative dermatitis or skin changes with pain interfering with function.
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
General Grade GuidelinesGrade 0 No Adverse Event
▫ Sign/symptom within normal limits
Grade 1 Mild Adverse Event (any of the following)
▫ Minor
▫ Mild symptoms and intervention not indicated
▫ Non-prescription intervention indicated
▫ No specific medical intervention
▫ Asymptomatic laboratory finding only
▫ Radiographic finding only
▫ Marginal clinical relevance
Grade 2 Moderate Adverse Event (any of the following)
▫ Intervention indicated
▫ Minimal, local, noninvasive intervention (e.g. packing, cautery)
▫ Limiting instrumental ADL (e.g., shopping; laundry; transportation; conduct finances)
Grade 3 Severe Adverse Event (any of the following)
▫ Medically significant but not life-threatening
▫ Inpatient or prolongation of hospitalization indicated
▫ Important medical event that does not result in hospitalization but may jeopardize the
patient or may require intervention either
▫ to prevent hospitalization or
▫ to prevent the AE from becoming life-threatening or potentially resulting in death
▫ Disabling - results in persistent or significant disability or incapacity
▫ Limiting self care ADL (e.g., getting in and out of bed; dressing; eating; getting around inside;
bathing; using the toilet)
Grade 4 Life-threatening Adverse Event (any of the following)
▫ Life-threatening consequences
▫ Urgent intervention indicated
▫ Urgent operative intervention indicated
▫ Patient is at risk of death at the time of the event if immediate intervention is not
undertaken
Grade 5 Fatal Adverse Event
▫ Death
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