CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Skin and subcutaneous tissue disorders

The 41 CTCAE v6.0 adverse events in Skin and subcutaneous tissue disorders, with grades 1 to 5.

Alopecia

Skin and subcutaneous tissue disorders
  1. G1Hair 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
  2. G2Hair 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
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location.

MedDRA code (LLT): 10001760 · CTCAE v6.0 (NCI), original English text.

Body odor

Skin and subcutaneous tissue disorders
  1. G1Mild odor; physician intervention not indicated; self care interventions
  2. G2Pronounced odor; psychosocial impact; patient seeks medical intervention
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an abnormal body smell resulting from the growth of bacteria on the body.

MedDRA code (LLT): 10005901 · CTCAE v6.0 (NCI), original English text.

Dermatitis psoriasiform

Skin and subcutaneous tissue disordersNew in v6.0
  1. G1Present; topical intervention indicated
  2. G2oral intervention indicated
  3. G3IV intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by large, red, rounded plaques covered with thicker scales.

MedDRA code (LLT): 10058675 · CTCAE v6.0 (NCI), original English text.

Dermatosis bullous

Skin and subcutaneous tissue disordersNew in v6.0
  1. G1Asymptomatic
  2. G2Painful blisters; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Blisters covering >50% BSA; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Blisters covering >75% BSA; associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the skin characterized by the presence of bullae which are filled with fluid.

Navigational noteIf infectious, consider Infections and infestations: Rash pustular or other site-specific Infections and infestations term.

MedDRA code (LLT): 10012519 · CTCAE v6.0 (NCI), original English text.

Dry skin

Skin and subcutaneous tissue disorders
  1. G1No associated erythema or pruritus
  2. G2Associated with erythema or pruritus; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture.

MedDRA code (LLT): 10013786 · CTCAE v6.0 (NCI), original English text.

Eczematous dermatitis

Skin and subcutaneous tissue disordersNew in v6.0
  1. G1Present; topical intervention indicated
  2. G2Oral intervention indicated
  3. G3IV intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by dry and itchy patches of skin involving the epidermis and superficial dermis and includes some scaling, crusting, or serous oozing.

MedDRA code (LLT): 10014206 · CTCAE v6.0 (NCI), original English text.

Erythema multiforme

Skin and subcutaneous tissue disorders
  1. G1Not associated with skin tenderness
  2. G2Associated with skin tenderness
  3. G3Associated with oral or genital erosions
  4. G4Associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by target lesions (a pink-red ring around a pale center).

MedDRA code (LLT): 10015218 · CTCAE v6.0 (NCI), original English text.

Erythroderma

Skin and subcutaneous tissue disorders
  1. G1Not applicable
  2. G2Erythema covering >90% BSA without associated symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Erythema covering >90% BSA with associated symptoms (e.g., pruritus or tenderness); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Erythema covering >90% BSA with associated fluid or electrolyte abnormalities; ICU care or burn unit indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by generalized inflammatory erythema and exfoliation. The inflammatory process involves >90% of the body surface area.

MedDRA code (LLT): 10015277 · CTCAE v6.0 (NCI), original English text.

Exfoliative dermatitis

Skin and subcutaneous tissue disordersNew in v6.0
  1. G1Present; topical intervention indicated
  2. G2oral intervention indicated
  3. G3IV intervention indicated
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by diffuse erythema and scaling involving > 90% of the body surface area.

MedDRA code (LLT): 10015665 · CTCAE v6.0 (NCI), original English text.

Hair color changes

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by change in hair color or loss of normal pigmentation.

MedDRA code (LLT): 10055525 · CTCAE v6.0 (NCI), original English text.

Hair texture abnormal

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a change in the way the hair feels.

MedDRA code (LLT): 10019049 · CTCAE v6.0 (NCI), original English text.

Hirsutism

Skin and subcutaneous tissue disorders
  1. G1In women, increase in length, thickness or density of hair in a male distribution that the patient is able to camouflage by periodic shaving, bleaching, or removal of hair
  2. G2In women, increase in length, thickness or density of hair in a male distribution that requires daily shaving or consistent destructive means of hair removal to camouflage; associated with psychosocial impact
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the presence of excess hair growth in women in anatomic sites where growth is considered to be a secondary male characteristic and under androgen control (beard, moustache, chest, abdomen).

MedDRA code (LLT): 10020112 · CTCAE v6.0 (NCI), original English text.

Hyperhidrosis

Skin and subcutaneous tissue disorders
  1. G1Limited to one site (palms, soles, or axillae); self care interventions
  2. G2Involving >1 site; patient seeks medical intervention; associated with psychosocial impact
  3. G3Associated with electrolyte/hemodynamic imbalance
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by excessive sweating.

Navigational noteSynonym: Night sweats, diaphoresis.

MedDRA code (LLT): 10020642 · CTCAE v6.0 (NCI), original English text.

Hyperkeratosis

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Not applicable
  3. G3Limiting self-care ADLs or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a thickening of the outer layer of the skin.

MedDRA code (LLT): 10020649 · CTCAE v6.0 (NCI), original English text.

Hypertrichosis

Skin and subcutaneous tissue disorders
  1. G1Increase in length, thickness or density of hair that the patient is either able to camouflage by periodic shaving or removal of hairs or is not concerned enough about the overgrowth to use any form of hair removal
  2. G2Increase in length, thickness or density of hair at least on the usual exposed areas of the body [face (not limited to beard/moustache area) plus/minus arms] that requires frequent shaving or use of destructive means of hair removal to camouflage; associated with psychosocial impact
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by hair density or length beyond the accepted limits of normal in a particular body region, for a particular age or race.

MedDRA code (LLT): 10020864 · CTCAE v6.0 (NCI), original English text.

Hypohidrosis

Skin and subcutaneous tissue disorders
  1. G1Not applicable
  2. G2Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Increase in body temperature; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by reduced sweating.

MedDRA code (LLT): 10021013 · CTCAE v6.0 (NCI), original English text.

Lichenoid dermatitis

Skin and subcutaneous tissue disordersNew in v6.0
  1. G1Present; topical intervention indicated
  2. G2oral intervention indicated
  3. G3IV intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a symmetric eruption of flat-topped, red or purple papules on the trunk and extremities.

MedDRA code (LLT): 10024441 · CTCAE v6.0 (NCI), original English text.

Nail changes

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a change in the nails.

MedDRA code (LLT): 10028689 · CTCAE v6.0 (NCI), original English text.

Nail discoloration

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a change in the color of the nail plate.

MedDRA code (LLT): 10028691 · CTCAE v6.0 (NCI), original English text.

Nail loss

Skin and subcutaneous tissue disorders
  1. G1Asymptomatic separation of the nail bed from the nail plate or nail loss
  2. G2Symptomatic separation of the nail bed from the nail plate or nail loss; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by loss of all or a portion of the nail.

MedDRA code (LLT): 10049281 · CTCAE v6.0 (NCI), original English text.

Nail ridging

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by vertical or horizontal ridges on the nails.

MedDRA code (LLT): 10062283 · CTCAE v6.0 (NCI), original English text.

Pain of skin

Skin and subcutaneous tissue disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the skin.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10033474 · CTCAE v6.0 (NCI), original English text.

Palmar-plantar erythrodysesthesia syndrome

Skin and subcutaneous tissue disorders
  1. G1Minimal skin changes or dermatitis (e.g., erythema, edema, or hyperkeratosis) without pain
  2. G2Skin changes (e.g., peeling, blisters, bleeding, fissures, edema, or hyperkeratosis) with pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe skin changes (e.g., peeling, blisters, bleeding, fissures, edema, or hyperkeratosis) with pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by redness, marked discomfort, swelling, and tingling in the palms of the hands or the soles of the feet. Also known as Hand-Foot Syndrome.

MedDRA code (LLT): 10054524 · CTCAE v6.0 (NCI), original English text.

Papulovesicular rash

Skin and subcutaneous tissue disordersNew in v6.0
  1. G1Asymptomatic
  2. G2Associated with psychosocial impact; mild symptoms
  3. G3Covering >50% BSA; moderate or severe symptoms
  4. G4Blisters covering >75% BSA; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by an eruption consisting of papules (a small, raised pimple) and vesicles (a small fluid filled blister).

MedDRA code (LLT): 10033740 · CTCAE v6.0 (NCI), original English text.

Photosensitivity

Skin and subcutaneous tissue disorders
  1. G1Painless erythema
  2. G2Tender erythema
  3. G3Erythema with blistering; oral corticosteroid therapy indicated; pain control indicated (e.g., narcotics or NSAIDs)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an increase in sensitivity of the skin to light.

MedDRA code (LLT): 10034966 · CTCAE v6.0 (NCI), original English text.

Pruritus

Skin and subcutaneous tissue disorders
  1. G1Mild or localized; topical intervention indicated
  2. G2Widespread and intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Widespread and constant; systemic corticosteroid or immunosuppressive therapy indicated; limiting sleep or self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an intense itching sensation.

MedDRA code (LLT): 10037087 · CTCAE v6.0 (NCI), original English text.

Purpura

Skin and subcutaneous tissue disorders
  1. G1Combined area of lesions covering <10% BSA
  2. G2Combined area of lesions covering 10 - 30% BSA
  3. G3Combined area of lesions covering >30% BSA
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA 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.

MedDRA code (LLT): 10037549 · CTCAE v6.0 (NCI), original English text.

Pustular drug eruption

Skin and subcutaneous tissue disordersNew in v6.0
  1. G1Asymptomatic
  2. G2Associated with psychosocial impact; oral antibiotics or steroid indicated; local intervention indicated (e.g., topical antibiotic, antifungal, or antiviral); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; IV antibiotic or steroid indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by the development of nonfollicular, sterile pustules on an erythematous base.

MedDRA code (LLT): 10082061 · CTCAE v6.0 (NCI), original English text.

Rash maculo-papular

Skin and subcutaneous tissue disorders
  1. G1Asymptomatic
  2. G2Mild symptoms
  3. G3Macules/papules covering >50% BSA; moderate or severe symptoms
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA 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 pruritis.

Navigational noteConsider Skin and subcutaneous tissue disorders: Pustular drug eruption.

MedDRA code (LLT): 10037868 · CTCAE v6.0 (NCI), original English text.

Scalp pain

Skin and subcutaneous tissue disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the skin covering the top and the back of the head.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10049120 · CTCAE v6.0 (NCI), original English text.

Skin and subcutaneous tissue disorders - Other, specify

Skin and subcutaneous tissue disorders
  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

MedDRA code (LLT): 10040785 · CTCAE v6.0 (NCI), original English text.

Skin atrophy

Skin and subcutaneous tissue disorders
  1. G1Associated with telangiectasias or changes in skin color
  2. G2Associated with striae or adnexal structure loss
  3. G3Associated with ulceration
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the degeneration and thinning of the epidermis and dermis.

MedDRA code (LLT): 10040799 · CTCAE v6.0 (NCI), original English text.

Skin hyperpigmentation

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Associated with psychosocial impact
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by darkening of the skin due to excessive melanin deposition.

MedDRA code (LLT): 10040865 · CTCAE v6.0 (NCI), original English text.

Skin hypopigmentation

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Associated with psychosocial impact
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by loss of skin pigment (e.g., vitiligo).

MedDRA code (LLT): 10040868 · CTCAE v6.0 (NCI), original English text.

Skin induration

Skin and subcutaneous tissue disorders
  1. G1Mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up)
  2. G2Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Generalized; associated with signs or symptoms of impaired breathing or feeding
  5. G5Death
Definition and note

DefinitionA disorder characterized by an area of hardness in the skin.

MedDRA code (LLT): 10051837 · CTCAE v6.0 (NCI), original English text.

Skin ulceration

Skin and subcutaneous tissue disorders
  1. G1Combined area of ulcers <1 cm; nonblanchable erythema of intact skin with associated warmth or edema
  2. G2Combined area of ulcers 1 - 2 cm; partial thickness skin loss involving skin or subcutaneous fat
  3. G3Combined area of ulcers >2 cm; full-thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to fascia
  4. G4Any size ulcer with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the skin.

MedDRA code (LLT): 10040947 · CTCAE v6.0 (NCI), original English text.

Stevens-Johnson syndrome

Skin and subcutaneous tissue disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Skin sloughing covering <10% BSA
  4. G4Skin sloughing covering >=10% BSA; life-threatening consequences
  5. G5Death
Definition and note

DefinitionA 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.

MedDRA code (LLT): 10042033 · CTCAE v6.0 (NCI), original English text.

Subcutaneous emphysema

Skin and subcutaneous tissue disorders
  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by air in the subcutaneous tissue.

MedDRA code (LLT): 10042344 · CTCAE v6.0 (NCI), original English text.

Telangiectasia

Skin and subcutaneous tissue disorders
  1. G1Present
  2. G2Associated with psychosocial impact
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by local dilatation of small vessels resulting in red discoloration of the skin or mucous membranes.

MedDRA code (LLT): 10043189 · CTCAE v6.0 (NCI), original English text.

Toxic epidermal necrolysis

Skin and subcutaneous tissue disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Skin sloughing covering >=30% BSA with associated symptoms (e.g., erythema, purpura, or epidermal detachment); life-threatening consequences
  5. G5Death
Definition and note

DefinitionA 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.

MedDRA code (LLT): 10044223 · CTCAE v6.0 (NCI), original English text.

Urticaria

Skin and subcutaneous tissue disorders
  1. G1Topical intervention indicated
  2. G2Oral intervention indicated
  3. G3IV intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an itchy skin eruption characterized by wheals with pale interiors and well-defined red margins.

Navigational noteConsider Immune system disorders: Allergic reaction, Anaphylaxis.

MedDRA code (LLT): 10046735 · CTCAE v6.0 (NCI), original English text.

From the same authorCódigo OncoCódigo Onco (in Portuguese): Brazilian public health system (SUS) codes for systemic cancer treatment.