Table 1:
Grading of cutaneous adverse events according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE)6
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
---|---|---|---|---|---|
Overall | Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated | Moderate; minimal, local or noninvasive intervention indicated; limiting age- appropriate instrumental activities of daily living (ADL) | Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL | Life-threatening consequences; urgent intervention indicated | Death related to adverse event |
Pruritus | Mild or localized; topical intervention indicated | Widespread and intermittent; skin changes from scratching; oral intervention indicated; limiting instrumental ADL | Widespread and constant; limiting self-care ADL or sleep; systemic corticosteroid or immunosuppressive therapy indicated | X | X |
Maculopapular Rash | Macules/papules covering <10% BSA with or without symptoms | Macules/papules covering 10–30% BSA with or without symptoms; limiting instrumental ADL; rash covering >30% BSA with or without mild symptoms | Macules/papules covering >30% BSA with moderate or severe symptoms; limiting self-care ADL | X | X |
Lichenoid reactions | Covering < 10% BSA and no associated symptom | Covering 10–30% BSA and associated with erythema or pruritus; limiting instrumental ADL | Covering >30% BSA and associated with pruritus; limiting self-care ADL | X | X |
Vitiligo-like depigmentation | Hypopigmentation or depigmentation covering <10% BSA; no psychosocial impact | Hypopigmentation or depigmentation covering >10% BSA; associated with psychosocial impact | x | X | X |
Blistering adverse events | 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 |
Stevens-Johnson syndrome | X | X | Skin sloughing covering <10% BSA with associated signs (erythema, purpura, epidermal detachment, and mucous membrane detachment) | Skin sloughing covering 10-30% BSA with associated signs (like in grade 3) | Death |
Toxic epidermal necrolysis | X | X | X | Skin sloughing covering >=30% BSA with associated symptoms (erythema, purpura or epidermal detachment) | Death |
Alopecia | Hair loss less than 50% normal for that individual, not obvious from a distance | Hair loss >= 50% of normal, readily apparent to others and requiring a wig | X | X | X |
Nail changes | Clinical or diagnostic observation of discoloration; asymptomatic separation of the nail bed from the nail plate or nail loss | Symptomatic separation of the nail bed; limiting instrumental ADL | X | X | X |