Category:CTCAE4 Injury, poisoning and procedural complications

From BiomedGT

Adverse Event	Grade1	Grade2	Grade3	Grade4	Grade5
Ankle fracture	Mild; non-surgical intervention indicated	Limiting instrumental ADL; operative intervention indicated	Limiting self care ADL; elective surgery indicated	-	-
Aortic injury	-	-	Severe symptoms; limiting self care ADL; disabling; repair or revision indicated	Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated	Death
Arterial injury	Asymptomatic diagnostic finding; intervention not indicated	Symptomatic (e.g., claudication); repair or revision not indicated	Severe symptoms; limiting self care ADL; disabling; repair or revision indicated	Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated	Death
Biliary anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Bladder anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Bruising	Localized or in a dependent area	Generalized	-	-	-
Burn	Minimal symptoms; intervention not indicated	Medical intervention; minimal debridement indicated	Moderate to major debridement or reconstruction indicated	Life-threatening consequences	Death
Dermatitis radiation	Faint erythema or dry desquamation	Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema	Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion	Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated	Death
Esophageal anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Fall	Minor with no resultant injuries; intervention not indicated	Symptomatic; noninvasive intervention indicated	Hospitalization indicated	-	-
Fallopian tube anastomotic leak	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Fallopian tube perforation	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic and intervention not indicated	Severe symptoms; elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated (e.g., organ resection)	Death
Fracture	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic but non-displaced; immobilization indicated	Severe symptoms; displaced or open wound with bone exposure; disabling; operative intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Gastric anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Gastrointestinal anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Gastrointestinal stoma necrosis	-	Superficial necrosis; intervention not indicated	Severe symptoms; hospitalization or elective operative intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Hip fracture	-	Hairline fracture; mild pain; limiting instrumental ADL; non-surgical intervention indicated	Severe pain; hospitalization or intervention indicated for pain control (e.g., traction); operative intervention indicated	Life-threatening consequences; symptoms associated with neurovascular compromise	-
Injury to carotid artery	-	-	Severe symptoms; limiting self care ADL (e.g., transient cerebral ischemia); repair or revision indicated	Life-threatening consequences; urgent intervention indicated	Death
Injury to inferior vena cava	-	-	-	Life-threatening consequences; urgent intervention indicated	Death
Injury to jugular vein	-	-	Symptomatic limiting self care ADL; disabling; repair or revision indicated	Life-threatening consequences; urgent intervention indicated	Death
Injury to superior vena cava	Asymptomatic diagnostic finding; intervention not indicated	Symptomatic; repair or revision not indicated	Severe symptoms; limiting self care ADL; disabling; repair or revision indicated	Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated	Death
Injury, poisoning and procedural complications - 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
Intestinal stoma leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Intestinal stoma obstruction	-	Self-limited; intervention not indicated	Severe symptoms; IV fluids, tube feeding, or TPN indicated >=24 hrs; elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Intestinal stoma site bleeding	Minimal bleeding identified on clinical exam; intervention not indicated	Moderate bleeding; medical intervention indicated	Severe bleeding; transfusion indicated; radiologic or endoscopic intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative arterial injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative breast injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative cardiac injury	-	-	Primary repair of injured organ/structure indicated	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative ear injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection of injured organ/structure indicated; disabling (e.g., impaired hearing; impaired balance)	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative endocrine injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative gastrointestinal injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative head and neck injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative hemorrhage	-	-	Postoperative radiologic, endoscopic, or operative intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative hepatobiliary injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative musculoskeletal injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative neurological injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative ocular injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative renal injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative reproductive tract injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative respiratory injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative skin injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative splenic injury	-	Primary repair of injured organ/structure indicated	Resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative urinary injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Intraoperative venous injury	Primary repair of injured organ/structure indicated	Partial resection of injured organ/structure indicated	Complete resection or reconstruction of injured organ/structure indicated; disabling	Life-threatening consequences; urgent intervention indicated	Death
Kidney anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Large intestinal anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Pancreatic anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Pharyngeal anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Postoperative hemorrhage	Minimal bleeding identified on clinical exam; intervention not indicated	Moderate bleeding; radiologic, endoscopic, or operative intervention indicated	Transfusion indicated of >=2 units (10 cc/kg for pediatrics) pRBCs beyond protocol specification; urgent radiologic, endoscopic, or operative intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Postoperative thoracic procedure complication	-	Extubated within 24 - 72 hrs postoperatively	Extubated >72 hrs postoperatively, but before tracheostomy indicated	Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)	Death
Prolapse of intestinal stoma	Asymptomatic; reducible	Recurrent after manual reduction; local irritation or stool leakage; difficulty to fit appliance; limiting instrumental ADL	Severe symptoms; elective operative intervention indicated; limiting self care ADL	Life-threatening consequences; urgent operative intervention indicated	Death
Prolapse of urostomy	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Local care or maintenance; minor revision indicated	Dysfunctional stoma; elective operative intervention or major stomal revision indicated	Life-threatening consequences; urgent intervention indicated	Death
Radiation recall reaction (dermatologic)	Faint erythema or dry desquamation	Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema	Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion	Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated	Death
Rectal anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Seroma	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic; simple aspiration indicated	Symptomatic, elective radiologic or operative intervention indicated	-	-
Small intestinal anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Spermatic cord anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Spinal fracture	Mild back pain; non-prescription analgesics indicated	Moderate back pain; prescription analgesics indicated; limiting instrumental ADL	Severe back pain; hospitalization or intervention indicated for pain control (e.g., vertebroplasty); limiting self care ADL; disability	Life-threatening consequences; symptoms associated with neurovascular compromise	Death
Stenosis of gastrointestinal stoma	-	Symptomatic; IV fluids indicated <24 hrs; manual dilatation at bedside	Severely altered GI function; tube feeding, TPN or hospitalization indicated; elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Stomal ulcer	Asymptomatic; clinical or diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; elective operative intervention indicated	-	-
Tracheal hemorrhage	Minimal bleeding identified on clinical or diagnostic exam; intervention not indicated	Moderate bleeding; medical intervention indicated	Severe bleeding; transfusion indicated; radiologic or endoscopic intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Tracheal obstruction	Partial asymptomatic obstruction on examination (e.g., visual, radiologic or endoscopic)	Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL	Stridor; radiologic or endoscopic intervention indicated (e.g., stent, laser); limiting self care ADL	Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)	Death
Tracheostomy site bleeding	Minimal bleeding identified on clinical exam; intervention not indicated	Moderate bleeding; medical intervention indicated	Severe bleeding; transfusion indicated; radiologic or endoscopic intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Ureteric anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Urethral anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Urostomy leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Urostomy obstruction	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; dilation or endoscopic repair or stent placement indicated	Altered organ function (e.g., sepsis or hydronephrosis, or renal dysfunction); elective operative intervention indicated	Life-threatening consequences; organ failure; urgent operative intervention indicated	Death
Urostomy site bleeding	Minimal bleeding identified on clinical exam; intervention not indicated	Moderate bleeding; medical intervention indicated	Severe bleeding; transfusion indicated; radiologic or endoscopic intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Urostomy stenosis	-	Symptomatic but no hydronephrosis, no sepsis or no renal dysfunction; dilation or endoscopic repair or stent placement indicated	Symptomatic (e.g., hydronephrosis, or renal dysfunction); elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Uterine anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Uterine perforation	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic and intervention not indicated	Severe symptoms; elective operative intervention indicated	Life-threatening consequences; urgent intervention indicated	Death
Vaginal anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Vas deferens anastomotic leak	Asymptomatic diagnostic observations only; intervention not indicated	Symptomatic; medical intervention indicated	Severe symptoms; radiologic, endoscopic or elective operative intervention indicated	Life-threatening consequences; urgent operative intervention indicated	Death
Vascular access complication	-	Device dislodgement, blockage, leak, or malposition; device replacement indicated	Deep vein or cardiac thrombosis; intervention indicated (e.g., anticoagulation, lysis, filter, invasive procedure)	Embolic event including pulmonary embolism or life-threatening thrombus	Death
Venous injury	Asymptomatic diagnostic finding; intervention not indicated	Symptomatic (e.g., claudication); repair or revision not indicated	Severe symptoms; limiting self care ADL; repair or revision indicated; disabling	Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated	Death
Wound complication	Incisional separation of <=25% of wound, no deeper than superficial fascia	Incisional separation >25% of wound; local care indicated	Hernia without evidence of strangulation; fascial disruption/dehiscence; primary wound closure or revision by operative intervention indicated	Hernia with evidence of strangulation; major reconstruction flap, grafting, resection, or amputation indicated	Death
Wound dehiscence	Incisional separation of <=25% of wound, no deeper than superficial fascia	Incisional separation >25% of wound with local care; asymptomatic hernia or symptomatic hernia without evidence of strangulation	Fascial disruption or dehiscence without evisceration; primary wound closure or revision by operative intervention indicated	Life-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicated	Death
Wrist fracture	Mild; non-surgical intervention indicated	Limiting instrumental ADL; operative intervention indicated	Limiting self care ADL; elective surgery indicated	-	-