Table 3.
CTCAE V.4 Grading Scale – source: NIH; no permission necessary
| Skin and subcutaneous tissue disorders | |||||
|---|---|---|---|---|---|
| Grade | |||||
| Adverse Event | 1 | 2 | 3 | 4 | 5 |
| Alopecia | Hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage | Hair loss of >=50% normal for that individual that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact | - | - | - |
| Definition: A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location. | |||||
| Body odor | Mild odor; physician intervention not indicated; self care interventions | Pronounced odor; psychosocial impact; patient seeks medical intervention | - | - | - |
| Definition: A disorder characterized by an abnormal body smell resulting from the growth of bacteria on the body. | |||||
| Bullous dermatitis | Asymptomatic; blisters covering <10% BSA | Blisters covering 10–30% BSA; painful blisters; limiting instrumental ADL | Blisters covering >30% BSA; limiting self care ADL | Blisters covering >30% BSA; associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated | Death |
| Definition: A disorder characterized by inflammation of the skin characterized by the presence of bullae which are filled with fluid. | |||||
| Dry skin | Covering <10% BSA and no associated erythema or pruritus | Covering 10–30% BSA and associated with erythema or pruritus; limiting instrumental ADL | Covering >30% BSA and associated with pruritus; limiting self care ADL | - | - |
| Definition: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture. | |||||
| Erythema multiforme | Target lesions covering < 10% BSA and not associated with skin tenderness | Target lesions covering 10–30% BSA and associated with skin tenderness | Target lesions covering >30% BSA and associated with oral or genital erosions | Target lesions covering >30% BSA; associated with fluid or electrolyte abnormalities; ICU care or burn until indicated | Death |
| Definition: A disorder characterized by target lesions (a pink-red ring around a pale center). | |||||
| Erythroderma | - | Erythema covering >90% BSA without associated symptoms; limiting instrumental ADL | Erythema covering >90% BSA with associated symptoms (e.g., pruritus or tenderness); limiting self care ADL | Erythema covering >90% BSA with associated fluid or electrolyte abnormalities; ICU care or burn until indicated | Death |
| Definition: A disorder characterized by generalized inflammatory erythema and exfoliation. The inflammatory process involves >90% of the body surface area. | |||||
| Fat atrophy | Covering <10% BSA and asymptomatic | Covering 10–30% and associated with erythema or tenderness; limiting instrumental ADL | Covering >30% BSA; associated with erythema or tenderness; limiting self-care ADL | - | - |
| Definition: A disorder characterized by shrinking of adipose tissue. | |||||
| Pain of skin | Mild pain | Moderate pain; limiting instrumental ADL | Severe pain; limiting self care ADL | - | - |
| Definition: A disorder characterized by marked discomfort sensation in the skin. | |||||
| Periorbital edema | Soft or non-pitting | 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 | - | - |
| Definition: A disorder characterized by swelling due to an excessive accumulation of fluid around the orbits of the face. | |||||
| Photosensitivity | Painless erythema and erythema covering <10% BSA | Tender erythema covering 10–30% BSA | Erythema covering >30% BSA and erythema with blistering; photosensitivity; oral corticosteroid therapy indicated; pain control indicated (e.g., narcotics or NSAIDs) | Life-threatening consequences; urgent intervention indicated | Death |
| Definition: A disorder characterized by an increase in sensitivity of the skin to light. | |||||
| Pruritus | Mild or localized; topical intervention indicated | Intense or widespread; intermittent; skin changes from scratching (e.g., 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 | - | - |
| Definition: A disorder characterized by an intense itching sensation. | |||||
| Purpura | Combined area of lesions covering <10% BSA | Combined area of lesions covering 10–30% BSA; bleeding with trauma | Combined area of lesions covering >30% BSA; spontaneous bleeding | - | - |
| Definition: A disorder characterized by hemorrhagic areas of the skin and mucous membrane. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and eventually become a brownish-yellow color. | |||||
| Rash acneiform | Papules and/or pustules covering <10% BSA, which may or may not be associated with symptoms of pruritus or tenderness | Papules and/or pustules covering 10–30% 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% 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, which may or may not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with IV antibiotics indicated; life-threatening consequences | Death |
| Definition: A disorder characterized by an eruption of papules and pustules, typically appearing in face, scalp, upper chest and back. | |||||
| Rash maculo-papular | Macules/papules covering <10% BSA with or without symptoms (e.g., pruritus, burning, tightness) | Macules/papules covering 10–30% BSA with or without symptoms (e.g., pruritus, burning, tightness); limiting instrumental ADL | Macules/papules covering >30% with or without associated symptoms; limiting self care ADL | - | - |
| Definition: A disorder characterized by the presence of macules (flat) and papules (elevated). Also known as morbilliform rash, it is one of the most common cutaneous adverse events, frequently affecting the upper trunk, spreading centripetally and associated with pruritus. | |||||
| Scalp pain | Mild pain | Moderate pain; limiting instrumental ADL | Severe pain; limiting self care ADL | - | - |
| Definition: A disorder characterized by marked discomfort sensation in the skin covering the top and the back of the head. | |||||
| Skin atrophy | Covering <110% BSA; associated with telangiectasias or changes in skin color | Covering 10–30% BSA; associated with striae or adnexal structure loss | Covering >30% BSA; associated with ulceration | - | - |
| Definition: A disorder characterized by the degeneration and thinning of the epidermis and dermis. | |||||
| Skin hyperpigmentation | Hyperpigmentation covering <10% BSA; no psychosocial impact | Hyperpigmentation covering >10% BSA; associated psychosocial impact | - | - | - |
| Definition: A disorder characterized by darkening of the skin due to excessive melanin deposition. | |||||
| Skin hypopigmentation | Hypopigmentation or depigmentation covering <10% BSA; no psychosocial impact | Hyperpigmentation or depigmentation covering >10% BSA; associated psychosocial impact | - | - | - |
| Definition: A disorder characterized by loss of skin pigment. | |||||
| 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 (e.g., mouth, anus); limiting self care ADL | Generalized; associated with signs or symptoms of impaired breathing or feeding | Death |
| A disorder characterized by an area of hardness in the skin. | |||||
| Skin ulceration | Combined area of ulcers <1 cm; nonblanchable erythema of intact skin with associated warmth or edema | Combined area of ulcers 1–2 cm; partial thickness skin loss involving skin or subcutaneous fat | Combined area of ulcers >2 cm; full-thickness 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 full thickness skin loss | Death |
| Definition: A disorder characterized by circumscribed, inflammatory and necrotic erosive lesion on the skin. | |||||
| Stevens-Johnson syndrome (SJS) | - | - | Skin sloughing covering <10% BSA with associated signs (e.g., erythema, purpura, epidermal detachment and mucous membrane detachment) | Skin sloughing covering 10–30% BSA with associated signs (e.g., erythema, purpura, epidermal detachment and mucous membrane detachment) | Death |
| Definition: A disorder characterized by less than 10% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes. | |||||
| Telangiectasia | Telangiectasias covering <10% BSA | Telangiectasias covering >10% BSA; associated with psychosocial impact | - | - | - |
| Definition: A disorder characterized by local dilatation of small vessels resulting in red discoloration of the skin or mucous membranes. | |||||
| Toxic epidermal necrolysis (TEN) | - | - | - | Skin sloughing covering ≥30% BSA with associated symptoms (e.g., erythema, purpura, or epidermal detachment) | Death |
| Definition: A disorder characterized by greater than 30% total body skin area separation of dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes. | |||||
| Urticaria | Urticarial lesions covering <10% BSA; topical intervention indicated | Urticarial lesions covering 10–30% BSA; oral intervention indicated | Urticarial lesions covering >30% BSA; IV intervention indicated | - | - |
| Definition: A disorder characterized by an itchy skin eruption characterized by wheals with pale interiors and well-defined red margins. | |||||
| Skin and subcutaneous tissue disorders – 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 |