Category:CTCAE4 Musculoskeletal and connective tissue disorders

From BiomedGT

Adverse Event	Grade1	Grade2	Grade3	Grade4	Grade5
Abdominal soft tissue necrosis	-	Local wound care; medical intervention indicated (e.g., dressings or topical medications)	Operative debridement or other invasive intervention indicated (e.g. tissue reconstruction, flap or grafting)	Life-threatening consequences; urgent intervention indicated	Death
Arthralgia	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Arthritis	Mild pain with inflammation, erythema, or joint swelling	Moderate pain associated with signs of inflammation, erythema, or joint swelling; limiting instrumental ADL	Severe pain associated with signs of inflammation, erythema, or joint swelling; irreversible joint damage; disabling; limiting self care ADL	-	-
Avascular necrosis	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic; limiting instrumental ADL	Severe symptoms; limiting self care ADL, elective operative intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Back pain	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Bone pain	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Buttock pain	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Chest wall pain	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Exostosis	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic; limiting instrumental ADL	Severe symptoms; limiting self care ADL, elective operative intervention indicated	-	-
Fibrosis deep connective tissue	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 or orifice movement (e.g. mouth, anus); limiting self care ADL	Generalized; associated with signs or symptoms of impaired breathing or feeding	Death
Flank pain	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Generalized muscle weakness	Symptomatic; weakness perceived by patient but not evident on physical exam	Symptomatic; weakness evident on physical exam; weakness limiting instrumental ADL	Weakness limiting self care ADL; disabling	-	-
Growth suppression	Reduction in growth velocity by 10 - 29% ideally measured over the period of a year	Reduction in growth velocity by 30-49% ideally measured over the period of a year or 0 - 49% reduction in growth from the baseline growth curve	Reduction in growth velocity of >=50% ideally measured over the period of a year	-	-
Head soft tissue necrosis	-	Local wound care; medical intervention indicated (e.g., dressings or topical medications)	Operative debridement or other invasive intervention indicated (e.g. tissue reconstruction, flap or grafting)	Life-threatening consequences; urgent intervention indicated	Death
Joint effusion	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic; limiting instrumental ADL	Severe symptoms; limiting self care ADL; elective operative intervention indicated; disabling	-	-
Joint range of motion decreased	<=25% loss of ROM (range of motion); decreased ROM limiting athletic activity	>25 - 50% decrease in ROM; limiting instrumental ADL	>50% decrease in ROM; limiting self care ADL; disabling	-	-
Joint range of motion decreased cervical spine	Mild restriction of rotation or flexion between 60 - 70 degrees	Rotation <60 degrees to right or left; <60 degrees of flexion	Ankylosed/fused over multiple segments with no C-spine rotation	-	-
Joint range of motion decreased lumbar spine	Stiffness; difficulty bending to the floor to pick up a very light object but able to do athletic activity	Pain with range of motion (ROM) in lumbar spine; requires a reaching aid to pick up a very light object from the floor	<50% lumbar spine flexion; associated with symptoms of ankylosis or fused over multiple segments with no L-spine flexion (e.g., unable to reach to floor to pick up a very light object)	-	-
Kyphosis	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Moderate accentuation; limiting instrumental ADL	Severe accentuation; operative intervention indicated; limiting self care ADL	-	-
Lordosis	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Moderate accentuation; limiting instrumental ADL	Severe accentuation; operative intervention indicated; limiting self care ADL	-	-
Muscle weakness left-sided	Symptomatic; perceived by patient but not evident on physical exam	Symptomatic; evident on physical exam; limiting instrumental ADL	Limiting self care ADL; disabling	-	-
Muscle weakness lower limb	Symptomatic; perceived by patient but not evident on physical exam	Symptomatic; evident on physical exam; limiting instrumental ADL	Limiting self care ADL; disabling	-	-
Muscle weakness right-sided	Symptomatic; perceived by patient but not evident on physical exam	Symptomatic; evident on physical exam; limiting instrumental ADL	Limiting self care ADL; disabling	-	-
Muscle weakness trunk	Symptomatic; perceived by patient but not evident on physical exam	Symptomatic; evident on physical exam; limiting instrumental ADL	Limiting self care ADL; disabling	-	-
Muscle weakness upper limb	Symptomatic; perceived by patient but not evident on physical exam	Symptomatic; evident on physical exam; limiting instrumental ADL	Limiting self care ADL; disabling	-	-
Musculoskeletal and connective tissue disorder - 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
Musculoskeletal deformity	Cosmetically and functionally insignificant hypoplasia	Deformity, hypoplasia, or asymmetry able to be remediated by prosthesis (e.g., shoe insert) or covered by clothing	Significant deformity, hypoplasia, or asymmetry, unable to be remediated by prosthesis or covered by clothing; disabling	-	-
Myalgia	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Myositis	Mild pain	Moderate pain associated with weakness; pain limiting instrumental ADL	Pain associated with severe weakness; limiting self care ADL	-	-
Neck pain	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Neck soft tissue necrosis	-	Local wound care; medical intervention indicated (e.g., dressings or topical medications)	Operative debridement or other invasive intervention indicated (e.g. tissue reconstruction, flap or grafting)	Life-threatening consequences; urgent intervention indicated	Death
Osteonecrosis of jaw	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated (e.g., topical agents); limiting instrumental ADL	Severe symptoms; limiting self care ADL; elective operative intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Osteoporosis	Radiologic evidence of osteoporosis or Bone Mineral Density (BMD) t-score -1 to -2.5 (osteopenia); no loss of height or intervention indicated	BMD t-score <-2.5; loss of height <2 cm; anti-osteoporotic therapy indicated; limiting instrumental ADL	Loss of height >=2 cm; hospitalization indicated; limiting self care ADL	-	-
Pain in extremity	Mild pain	Moderate pain; limiting instrumental ADL	Severe pain; limiting self care ADL	-	-
Pelvic soft tissue necrosis	-	Local wound care; medical intervention indicated (e.g., dressings or topical medications)	Operative debridement or other invasive intervention indicated (e.g. tissue reconstruction, flap or grafting)	Life-threatening consequences; urgent intervention indicated	Death
Scoliosis	<20 degrees; clinically undetectable	>20 - 45 degrees; visible by forward flexion; limiting instrumental ADL	>45 degrees; scapular prominence in forward flexion; operative intervention indicated; limiting self care ADL; disabling	-	-
Soft tissue necrosis lower limb	-	Local wound care; medical intervention indicated (e.g., dressings or topical medications)	Operative debridement or other invasive intervention indicated (e.g. tissue reconstruction, flap or grafting)	Life-threatening consequences; urgent intervention indicated	Death
Soft tissue necrosis upper limb	-	Local wound care; medical intervention indicated (e.g., dressings or topical medications)	Operative debridement or other invasive intervention indicated (e.g. tissue reconstruction, flap or grafting)	Life-threatening consequences; urgent intervention indicated	Death
Superficial soft tissue fibrosis	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 or orifice movement (e.g. mouth, anus); limiting self care ADL	Generalized; associated with signs or symptoms of impaired breathing or feeding	Death
Trismus	Decreased ROM (range of motion) without impaired eating	Decreased ROM requiring small bites, soft foods or purees	Decreased ROM with inability to adequately aliment or hydrate orally	-	-
Unequal limb length	Mild length discrepancy <2 cm	Moderate length discrepancy 2 - 5 cm; shoe lift indicated; limiting instrumental ADL	Severe length discrepancy >5 cm; limiting self care ADL; disabling; operative intervention indicated	-	-