CTCAE v5.0 (Skin): Standardized classification of oncology-related adverse events.
Select Severity Level
Awaiting Grade
Select the description that best matches the severity of the skin reaction to determine the clinical CTCAE grade.
Guidelines & Evidence
Verified
Last Review: 2026-07-17
When to Use
When to Use
The Common Terminology Criteria for Adverse Events (CTCAE) is the standard vocabulary used by the National Cancer Institute (NCI) and the oncology community to report adverse events in clinical trials and routine care. The Skin and Subcutaneous Tissue Disorders category provides specific grading criteria for dermatologic toxicities associated with chemotherapy, targeted therapy, immunotherapy, and radiation.
Indications
Grading severity of dermatologic adverse events from antineoplastic therapies
Determining whether to hold, dose-reduce, or discontinue oncology drugs
Reporting toxicities in clinical trials (mandatory protocol requirement)
Standardizing communication between dermatology and oncology teams
When NOT to Use
Primary non-drug-induced dermatologic conditions (e.g., standard psoriasis, atopic dermatitis) — use PASI, EASI, BSA
When evaluating drug causality (use ALDEN or Naranjo algorithm for causality; CTCAE only grades severity)
How it Works
General Grading Framework (All CTCAE Categories)
| Grade 1 | Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. |
| Grade 2 | Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. |
| Grade 3 | Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. |
| Grade 4 | Life-threatening consequences; urgent intervention indicated. |
| Grade 5 | Death related to adverse event. |
Specific Example: Rash maculo-papular (e.g., Checkpoint Inhibitor Rash)
Grade 1: Macules/papules covering < 10% BSA with or without symptoms (e.g., pruritus, burning, tightness).
Grade 2: Macules/papules covering 10–30% BSA with or without symptoms; limiting instrumental ADL.
Grade 3: Macules/papules covering > 30% BSA with or without symptoms; limiting self care ADL.
Grade 4: Papulopustular rash associated with life-threatening superinfection; Stevens-Johnson syndrome, toxic epidermal necrolysis, or bullous dermatitis.
Grade 5: Death.
Specific Example: Pruritus
Grade 1: Mild or localized; topical intervention indicated.
Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; limiting instrumental ADL.
Grade 3: Intense or widespread; constant; limiting self care ADL or sleep; oral corticosteroid or immunosuppressive therapy indicated.
Specific Example: Bullous dermatitis (including SJS/TEN)
Grade 1: Asymptomatic blisters < 10% BSA.
Grade 2: Blisters 10–30% BSA; limiting instrumental ADL.
Grade 3: Blisters > 30% BSA; limiting self care ADL.
Grade 4: Life-threatening consequences; epidermal necrosis; Stevens-Johnson syndrome or toxic epidermal necrolysis.
Clinical Pearls
Clinical Pearls
In dermatology consultations for oncology, always document the CTCAE grade explicitly in the assessment (e.g., "Grade 2 maculopapular rash secondary to pembrolizumab"). Oncology protocols dictate dose holds based on these specific grades.
Grade 3 is typically the threshold where oncology therapy is held and systemic dermatologic treatment (e.g., oral prednisone 0.5–1 mg/kg) is initiated.
Instrumental ADL (Grade 2) refers to preparing meals, shopping, managing money/phone. Self-care ADL (Grade 3) refers to bathing, dressing/undressing, feeding self, using toilet, taking medications.
BSA percentages used in CTCAE (10% and 30% thresholds) can be estimated using the Palm Method (1 patient palm = 1% BSA) or Rule of Nines.
Next Steps
Oncology Dose Modification Guidelines (General Checkpoint Inhibitor Framework)
01
Grade 1 (Mild): Continue immunotherapy. Treat symptomatically (medium-potency topical corticosteroids, oral antihistamines).
02
Grade 2 (Moderate): Consider holding immunotherapy depending on tolerability. Escalate symptomatic treatment (high-potency topical corticosteroids). Rechallenge when resolved to Grade ≤ 1.
03
Grade 3 (Severe): HOLD immunotherapy. Initiate systemic corticosteroids (e.g., prednisone 0.5–1.0 mg/kg/day) and taper over at least 4 weeks. Dermatology consult. Resume immunotherapy only after careful multidisciplinary review when resolved to Grade ≤ 1.
04
Grade 4 (Life-Threatening): PERMANENTLY DISCONTINUE immunotherapy. Immediate dermatology/burn unit consult. IV corticosteroids (e.g., methylprednisolone 1–2 mg/kg/day) or IVIG/infliximab depending on specific reaction (e.g., SJS/TEN).
The Evidence
Primary Reference
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
National Cancer Institute. • U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute.. 2017;Published November 27, 2017. The definitive standard for oncology adverse event reporting.
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Origins & History
The Common Toxicity Criteria (CTC) were first developed by the National Cancer Institute (NCI) in 1982 to provide a standard language for reporting adverse events in cancer clinical trials. In 2003, it was revised and renamed CTCAE to reflect its broader application beyond chemotherapy to targeted and immunotherapies. Version 5.0 was released in November 2017. The skin/dermatologic categories are vital for managing the unique class-effect toxicities of modern oncology drugs, particularly the immune-related adverse events (irAEs) associated with checkpoint inhibitors (PD-1/PD-L1/CTLA-4) and targeted inhibitors (EGFR/MEK/BRAF).
Last Comprehensive Review: 2026-07-17