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©2013 UpToDate ® Print Email Common terminology criteria for adverse events (CTCAE) version 4.0. Grading scale for skin and subcutaneous tissue disorders. CTCAEv4 term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Alopecia Hair loss of <50 percent normal for that individual that is not obvious from distance but only on close inspection; different hair style may be required to cover hair loss but it does not require wig or hairpiece to camouflage Hair loss of ≥50 percent normal for that individual that is readily apparent to others; wig or hairpiece is necessary if patient desires to completely camouflage hair loss; associated with psychosocial impact — — — Body odor Mild odor; physician intervention not indicated; self-care interventions Pronounced odor; psychosocial impact; patient seeks medical intervention — — — Bullous dermatitis Asymptomatic; blisters covering <10 percent BSA Blisters covering 10 to 30 percent BSA; painful blisters; limiting instrumental ADL Blisters covering >30 percent BSA; limiting self-care ADL Blisters covering >30 percent BSA; associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated Death Dry skin Covering <30 percent BSA and no associated erythema or pruritus Covering 10 to 30 percent BSA and associated with erythema or pruritus; limiting instrumental ADL Covering >30 percent BSA and associated with pruritus; limiting self-care ADL — — Erythema multiforme Target lesions covering <10 percent BSA and not associated with skin tenderness Target lesions covering 10 to 30 percent BSA and associated with skin tenderness Target lesions covering >30 percent BSA and associated with oral or genital erosions Target lesions covering >30 percent BSA; associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated Death Erythroderma — Erythema covering >90 percent BSA without associated symptoms; limiting instrumental ADL Erythema covering >90 percent BSA with associated symptoms (eg, pruritus or tenderness); limiting self-care ADL Erythema covering >90 percent BSA with associated fluid or electrolyte abnormalities; ICU care or burn unit indicated Death Fat atrophy Covering <10 percent BSA and asymptomatic Covering 10 to 30 percent BSA and associated with erythema or tenderness; limiting instrumental ADL Covering >30 percent BSA; associated with erythema or tenderness; limiting self-care ADL — — Hirsutism

Erythema covering >90 percent BSA with associated fluid or electrolyte abnormalities; ICU care or burn unit indicated Death Fat atrophy Covering <10 percent BSA and asymptomatic Covering 10 to 30 percent BSA and associated with erythema or tenderness; limiting instrumental ADL Covering >30 percent BSA; associated with erythema or tenderness; limiting self-care ADL — — Hirsutism In women, increase in length, thickness, or density of hair in male distribution that patient is able to camouflage by periodic shaving, bleaching, or removal of hair In women, increase in length, thickness, or density of hair in male distribution that requires daily shaving or consistent destructive means of hair removal to camouflage; associated with psychosocial impact — — — Hyperhidrosis Limited to one site (palms, soles, or axillae); self-care interventions Involving >1 site; patient seeks medical intervention; associated with psychosocial impact Generalized involving sites other than palms, soles, or axillae; associated with electrolyte/ hemodynamic imbalance — — Hypertrichosis Increase in length, thickness, or density of hair that patient is either able to camouflage by periodic shaving or removal of hairs or is not concerned enough about overgrowth to use any form of hair removal Increase in length, thickness, or density of hair at least on usual exposed areas of body (face [not limited to beard/ moustache area], arms) that requires frequent shaving or use of destructive means of hair removal to camouflage; associated with psychosocial impact — — — Hypohidrosis — Symptomatic; limiting instrumental ADL Increase in body temperature; limiting self-care ADL Heat stroke Death Lipohypertrophy Asymptomatic and covering <10 percent BSA Covering 10 to 30 percent BSA and associated tenderness; limiting instrumental ADL Covering >30 percent BSA and associated tenderness and narcotics or NSAIDs indicated; lipohypertrophy; limiting self-care ADL — — Nail discoloration Asymptomatic; clinical or diagnostic observations only; intervention not indicated — — — — Nail loss Asymptomatic separation of nail bed from nail plate or nail loss Symptomatic separation of nail bed from nail plate or nail loss; limiting instrumental ADL — — — Nail ridging Asymptomatic; clinical or diagnostic observations only; intervention not indicated — — — — Pain of skin Mild pain Moderate pain; limiting instrumental ADL Severe pain; limiting self-care ADL — —

Asymptomatic separation of nail bed from nail plate or nail loss Symptomatic separation of nail bed from nail plate or nail loss; limiting instrumental ADL — — — Nail ridging Asymptomatic; clinical or diagnostic observations only; intervention not indicated — — — — Pain of skin Mild pain Moderate pain; limiting instrumental ADL Severe pain; limiting self-care ADL — — Palmar-plantar erythrodysesthesia syndrome Minimal skin changes or dermatitis (eg, erythema, edema, or hyperkeratosis) without pain Skin changes (eg, peeling, blisters, bleeding, edema, or hyperkeratosis) with pain; limiting instrumental ADL Severe skin changes (eg, peeling, blisters, bleeding, edema, or hyperkeratosis) with pain; limiting self-care ADL — — Periorbital edema Soft or nonpitting Indurated or pitting edema; topical intervention indicated Edema associated with visual disturbance; increased intraocular pressure, glaucoma, or retinal hemorrhage; optic neuritis; diuretics indicated; operative intervention indicated — — Photosensitivity Painless erythema; erythema covering <10 percent BSA Tender erythema covering 10 to 30 percent BSA Erythema covering >30 percent BSA; erythema with blistering; photosensitivity; oral corticosteroid therapy indicated; pain control indicated (eg, narcotics or NSAIDs) Life-threatening consequences; urgent intervention indicated Death Pruritus Mild or localized; topical intervention indicated Intense or widespread; intermittent; skin changes from scratching (eg, edema, papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; limiting instrumental ADL Intense or widespread; constant; limiting self-care ADL or sleep; oral corticosteroid or immunosuppressive therapy indicated — — Purpura Combined area of lesions covering <10 percent BSA Combined area of lesions covering 10 to 30 percent BSA; bleeding with trauma Combined area of lesions covering >30 percent BSA; spontaneous bleeding — — Rash acneiform Papules and/or pustules covering <10 percent BSA, which may or may not be associated with symptoms of pruritus or tenderness Papules and/or pustules covering 10 to 30 percent BSA, which may or may not be associated with symptoms of pruritus or tenderness; associated with psychosocial impact; limiting instrumental ADL

Rash acneiform Papules and/or pustules covering <10 percent BSA, which may or may not be associated with symptoms of pruritus or tenderness Papules and/or pustules covering 10 to 30 percent BSA, which may or may not be associated with symptoms of pruritus or tenderness; associated with psychosocial impact; limiting instrumental ADL Papules and/or pustules covering >30 percent BSA, which may or may not be associated with symptoms of pruritus or tenderness; limiting self-care ADL; associated with local superinfection with oral antibiotics indicated Papules and/or pustules covering any BSA percent, which may or may not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with IV antibiotics indicated; lifethreatening consequences Death Rash maculopapular Macules/papules covering <10 percent BSA with or without symptoms (eg, pruritus, burning, tightness) Macules/papules covering 10 to 30 percent BSA with or without symptoms (eg, pruritus, burning, tightness); limiting instrumental ADL Macules/papules covering >30 percent BSA with or without associated symptoms; limiting self-care ADL — — Scalp pain Mild pain Moderate pain; limiting instrumental ADL Severe pain; limiting self-care ADL — — Skin atrophy Covering <10 percent BSA; associated with telangiectasias or changes in skin color Covering 10 to 30 percent BSA; associated with striae or adnexal structure loss Covering >30 percent BSA; associated with ulceration — — Skin hyperpigmentation Hyperpigmentation covering <10 percent BSA; no psychosocial impact Hyperpigmentation covering >10 percent BSA; associated psychosocial impact — — — Skin hypopigmentation Hypopigmentation or depigmentation covering <10 percent BSA; no psychosocial impact Hypopigmentation or depigmentation covering >10 percent BSA; associated psychosocial impact — — — Skin induration Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up) Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL Severe induration, unable to slide or pinch skin; limiting joint movement or orifice (eg, mouth, anus); limiting selfcare ADL Generalized; associated with signs or symptoms of impaired breathing or feeding Death Skin ulceration Combined area of ulcers <1 cm; nonblanchable erythema of intact skin with associated warmth or edema

Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL Severe induration, unable to slide or pinch skin; limiting joint movement or orifice (eg, mouth, anus); limiting selfcare ADL Generalized; associated with signs or symptoms of impaired breathing or feeding Death Skin ulceration Combined area of ulcers <1 cm; nonblanchable erythema of intact skin with associated warmth or edema Combined area of ulcers 1 to 2 cm; partial-thickness skin loss involving skin or subcutaneous fat Combined area of ulcers >2 cm; fullthickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to fascia Any size ulcer with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without fullthickness skin loss Death Stevens-Johnson syndrome — — Skin sloughing covering <10 percent BSA with associated signs (eg, erythema, purpura, epidermal detachment, and mucous membrane detachment Skin sloughing covering 10 to 30 percent BSA with associated signs (eg, erythema, purpura, epidermal detachment, and mucous membrane detachment) Death Telangiectasia Telangiectasias covering <10 percent BSA Telangiectasias covering >10 percent BSA; associated with psychosocial impact — — — Toxic epidermal necrolysis — — — Skin sloughing covering ≥30 percent BSA with associated symptoms (eg, erythema, purpura, or epidermal detachment Death Urticaria Urticarial lesions covering <10 percent BSA; topical intervention indicated Urticarial lesions covering 10 to 30 percent BSA; oral intervention indicated Urticarial lesions covering >30 percent BSA; IV intervention indicated — — Other, specify Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADL Life-threatening consequences; urgent intervention indicated Death

Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADL Life-threatening consequences; urgent intervention indicated Death Semicolon indicates "or" within description of grade. Single dash (-) indicates grade is not available. Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc. Self-care ADL refer to bathing, dressing and undressing, feeding self, using toilet, taking medications, and not bedridden. Not all grades are appropriate for all adverse events. Therefore, some adverse events are listed with fewer than five options for grade selection. ADL: activities of daily living; BSA: body surface area; CTCAEv4: Common Terminology Criteria for Adverse Events Version 4; ICU: intensive care unit; IV: intravenous; NSAIDs: nonsteroidal anti-inflammatory drugs. Reproduced from: Chen AP, Setser A, Anadkat MJ, et al. Grading dermatologic adverse events of cancer treatments: The Common Terminology Criteria for Adverse Events Version 4.0. J Am Acad Dermatol 2012; 67:1025. Table used with the permission of Elsevier Inc. All rights reserved.