CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Injury, poisoning and procedural complications

The 79 CTCAE v6.0 adverse events in Injury, poisoning and procedural complications, with grades 1 to 5.

Anesthetic complication

Injury, poisoning and procedural complicationsNew in v6.0
  1. G1Not applicable
  2. G2Any anesthesia effects requiring medical intervention for reversal of symptomatic effects and requiring unplanned hospitalization of <24 hours.
  3. G3Any anesthesia effects requiring medical intervention for reversal of symptomatic effects and requiring unplanned hospitalization of >=24 hours.
  4. G4Anesthesia effects with life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by reactions related to the administration of local or moderate sedation given for a procedure.

MedDRA code (LLT): 10054322 · CTCAE v6.0 (NCI), original English text.

Aortic injury

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Operative intervention not indicated
  3. G3Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of damage to the aorta.

MedDRA code (LLT): 10002899 · CTCAE v6.0 (NCI), original English text.

Arterial injury

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; repair or revision not indicated
  3. G3Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of damage to an artery.

MedDRA code (LLT): 10003162 · CTCAE v6.0 (NCI), original English text.

Biliary anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage of bile due to breakdown of a biliary anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10050458 · CTCAE v6.0 (NCI), original English text.

Bladder anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage of urine due to breakdown of a bladder anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065802 · CTCAE v6.0 (NCI), original English text.

Bruising

Injury, poisoning and procedural complications
  1. G1Localized or in a dependent area
  2. G2Generalized
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding of injury of the soft tissues or bone characterized by leakage of blood into surrounding tissues.

MedDRA code (LLT): 10006504 · CTCAE v6.0 (NCI), original English text.

Burn

Injury, poisoning and procedural complications
  1. G1Minimal symptoms; intervention not indicated
  2. G2Medical intervention; minimal debridement indicated
  3. G3Moderate to major debridement or reconstruction indicated
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA finding of impaired integrity to the anatomic site of an adverse thermal reaction. Burns can be caused by exposure to chemicals, direct heat, electricity, flames and radiation. The extent of damage depends on the length and intensity of exposure and time until provision of treatment.

MedDRA code (LLT): 10006634 · CTCAE v6.0 (NCI), original English text.

Dermatitis radiation

Injury, poisoning and procedural complications
  1. G1Faint erythema or dry desquamation
  2. G2Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
  3. G3Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
  4. G4Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
  5. G5Death
Definition and note

DefinitionA finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.

Navigational noteSynonym: Radiation induced skin toxicities (CTCAE v3.0 )

MedDRA code (LLT): 10061103 · CTCAE v6.0 (NCI), original English text.

Esophageal anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of an esophageal anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065961 · CTCAE v6.0 (NCI), original English text.

Fall

Injury, poisoning and procedural complications
  1. G1Minor with no resultant injuries; intervention not indicated
  2. G2Symptomatic; noninvasive intervention indicated
  3. G3Hospitalization indicated; invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding of sudden movement downward, usually resulting in injury.

MedDRA code (LLT): 10016173 · CTCAE v6.0 (NCI), original English text.

Fallopian tube anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a fallopian tube anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065788 · CTCAE v6.0 (NCI), original English text.

Fallopian tube perforation

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated (e.g., organ resection)
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture of the fallopian tube wall.

MedDRA code (LLT): 10065790 · CTCAE v6.0 (NCI), original English text.

Fracture

Injury, poisoning and procedural complications
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic but non-displaced; immobilization indicated
  3. G3Severe symptoms; displaced or open wound with bone exposure; operative intervention 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

DefinitionA state in which the continuity of the bone is broken.

MedDRA code (LLT): 10017076 · CTCAE v6.0 (NCI), original English text.

Gastric anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a gastric anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065893 · CTCAE v6.0 (NCI), original English text.

Gastrointestinal anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a gastrointestinal anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065879 · CTCAE v6.0 (NCI), original English text.

Gastrointestinal stoma necrosis

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Superficial necrosis; intervention not indicated
  3. G3Severe symptoms; hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the gastrointestinal tract stoma.

MedDRA code (LLT): 10065712 · CTCAE v6.0 (NCI), original English text.

Infusion related reaction

Injury, poisoning and procedural complications
  1. G1Mild transient reaction; infusion interruption not indicated; intervention not indicated
  2. G2Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (e.g., antihistamines, NSAIDS, narcotics, IV fluids); prophylactic medications indicated for <=24 hrs
  3. G3Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.

Navigational noteIf the reaction is an allergic reaction related to an agent, consider reporting as Immune system disorders: Allergic reaction. Do not report both.

MedDRA code (LLT): 10051792 · CTCAE v6.0 (NCI), original English text.

Injury to carotid artery

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Repair or revision not indicated
  3. G3Severe symptoms (e.g., transient cerebral ischemia); repair or revision 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

DefinitionA finding of damage to the carotid artery.

MedDRA code (LLT): 10022161 · CTCAE v6.0 (NCI), original English text.

Injury to inferior vena cava

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; repair or revision not indicated
  3. G3Severe symptoms; repair or revision 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

DefinitionA finding of damage to the inferior vena cava.

MedDRA code (LLT): 10022213 · CTCAE v6.0 (NCI), original English text.

Injury to jugular vein

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Repair or revision not indicated
  3. G3Symptomatic; repair or revision 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

DefinitionA finding of damage to the jugular vein.

MedDRA code (LLT): 10065849 · CTCAE v6.0 (NCI), original English text.

Injury to superior vena cava

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; repair or revision not indicated
  3. G3Severe symptoms; repair or revision 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

DefinitionA finding of damage to the superior vena cava.

MedDRA code (LLT): 10022356 · CTCAE v6.0 (NCI), original English text.

Injury, poisoning and procedural complications - Other, specify

Injury, poisoning and procedural complications
  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): 10022117 · CTCAE v6.0 (NCI), original English text.

Intestinal stoma leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage of contents from an intestinal stoma (surgically created opening on the surface of the body).

MedDRA code (LLT): 10059095 · CTCAE v6.0 (NCI), original English text.

Intestinal stoma obstruction

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Self-limited; intervention not indicated
  3. G3Severe symptoms; IV fluids, tube feeding, or TPN indicated >=24 hrs; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the contents of the intestinal stoma.

MedDRA code (LLT): 10059094 · CTCAE v6.0 (NCI), original English text.

Intestinal stoma site bleeding

Injury, poisoning and procedural complications
  1. G1Minimal bleeding identified on clinical exam; intervention not indicated
  2. G2Moderate bleeding; medical intervention indicated
  3. G3Invasive intervention indicated; hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the intestinal stoma.

MedDRA code (LLT): 10049468 · CTCAE v6.0 (NCI), original English text.

Intraoperative arterial injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to an artery during a surgical procedure.

MedDRA code (LLT): 10065826 · CTCAE v6.0 (NCI), original English text.

Intraoperative breast injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the breast parenchyma during a surgical procedure.

MedDRA code (LLT): 10065831 · CTCAE v6.0 (NCI), original English text.

Intraoperative cardiac injury

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Not applicable
  3. G3Primary repair of injured organ/structure indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of damage to the heart during a surgical procedure.

MedDRA code (LLT): 10065843 · CTCAE v6.0 (NCI), original English text.

Intraoperative ear injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure indicated; limiting self-care ADL (e.g., impaired hearing; impaired balance) or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of damage to the ear during a surgical procedure.

MedDRA code (LLT): 10065844 · CTCAE v6.0 (NCI), original English text.

Intraoperative endocrine injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the endocrine gland during a surgical procedure.

MedDRA code (LLT): 10065834 · CTCAE v6.0 (NCI), original English text.

Intraoperative gastrointestinal injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the gastrointestinal system during a surgical procedure.

MedDRA code (LLT): 10065825 · CTCAE v6.0 (NCI), original English text.

Intraoperative head and neck injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the head and neck during a surgical procedure.

MedDRA code (LLT): 10065842 · CTCAE v6.0 (NCI), original English text.

Intraoperative hemorrhage

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Not applicable
  3. G3Postoperative invasive intervention indicated; hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of uncontrolled bleeding during a surgical procedure.

MedDRA code (LLT): 10055298 · CTCAE v6.0 (NCI), original English text.

Intraoperative hepatobiliary injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the hepatic parenchyma and/or biliary tract during a surgical procedure.

MedDRA code (LLT): 10065827 · CTCAE v6.0 (NCI), original English text.

Intraoperative musculoskeletal injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the musculoskeletal system during a surgical procedure.

MedDRA code (LLT): 10065829 · CTCAE v6.0 (NCI), original English text.

Intraoperative neurological injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the nervous system during a surgical procedure.

MedDRA code (LLT): 10065830 · CTCAE v6.0 (NCI), original English text.

Intraoperative ocular injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the eye during a surgical procedure.

MedDRA code (LLT): 10065841 · CTCAE v6.0 (NCI), original English text.

Intraoperative renal injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the kidney during a surgical procedure.

MedDRA code (LLT): 10065845 · CTCAE v6.0 (NCI), original English text.

Intraoperative reproductive tract injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the reproductive organs during a surgical procedure.

MedDRA code (LLT): 10065840 · CTCAE v6.0 (NCI), original English text.

Intraoperative respiratory injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the respiratory system during a surgical procedure.

MedDRA code (LLT): 10065832 · CTCAE v6.0 (NCI), original English text.

Intraoperative splenic injury

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Primary repair of injured organ/structure indicated
  3. G3Resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the spleen during a surgical procedure.

MedDRA code (LLT): 10065847 · CTCAE v6.0 (NCI), original English text.

Intraoperative urinary injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to the urinary system during a surgical procedure.

MedDRA code (LLT): 10065828 · CTCAE v6.0 (NCI), original English text.

Intraoperative venous injury

Injury, poisoning and procedural complications
  1. G1Primary repair of injured organ/structure indicated
  2. G2Partial resection of injured organ/structure indicated
  3. G3Complete resection or reconstruction of injured organ/structure 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

DefinitionA finding of damage to a vein during a surgical procedure.

MedDRA code (LLT): 10065848 · CTCAE v6.0 (NCI), original English text.

Kidney anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage of urine due to breakdown of a kidney anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065803 · CTCAE v6.0 (NCI), original English text.

Large intestinal anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the large intestine.

MedDRA code (LLT): 10065891 · CTCAE v6.0 (NCI), original English text.

Nerve injury

Injury, poisoning and procedural complicationsNew in v6.0
  1. G1Not applicable
  2. G2Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Invasive intervention indicated; hospitalization; 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 finding of damage to a nerve.

MedDRA code (LLT): 10052897 · CTCAE v6.0 (NCI), original English text.

Pancreatic anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a pancreatic anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10050457 · CTCAE v6.0 (NCI), original English text.

Pharyngeal anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a pharyngeal anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065705 · CTCAE v6.0 (NCI), original English text.

Post biopsy bleeding

Injury, poisoning and procedural complicationsNew in v6.0
  1. G1Not applicable
  2. G2Requiring additional observation
  3. G3Transfusion indicated; invasive intervention indicated; hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding as a result of a biopsy procedure.

MedDRA code (LLT): 10054113 · CTCAE v6.0 (NCI), original English text.

Postoperative hemorrhage

Injury, poisoning and procedural complications
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate bleeding requiring transfusion <2 units (10 cc/kg for pediatrics) of pRBCs
  3. G3Transfusion indicated of >=2 units (10 cc/kg for pediatrics) pRBCs; invasive intervention indicated; hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding occurring after a surgical procedure.

Navigational noteConsider Injury, poisoning and procedural complications: Post biopsy bleeding.

MedDRA code (LLT): 10055322 · CTCAE v6.0 (NCI), original English text.

Postoperative thoracic procedure complication

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Extubated within 24 - 72 hrs postoperatively
  3. G3Extubated >72 hrs postoperatively, but before tracheostomy indicated
  4. G4Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
  5. G5Death
Definition and note

DefinitionA finding of a previously undocumented problem that occurs after a thoracic procedure.

MedDRA code (LLT): 10056745 · CTCAE v6.0 (NCI), original English text.

Prolapse of intestinal stoma

Injury, poisoning and procedural complications
  1. G1Asymptomatic; reducible
  2. G2Recurrent after manual reduction; local irritation or stool leakage; difficulty to fit appliance; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; elective operative intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of protrusion of the intestinal stoma (surgically created opening on the surface of the body) above the abdominal surface.

MedDRA code (LLT): 10065745 · CTCAE v6.0 (NCI), original English text.

Prolapse of urostomy

Injury, poisoning and procedural complications
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Local care or maintenance; minor revision indicated
  3. G3Dysfunctional stoma; elective operative intervention or major stomal revision indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of displacement of the urostomy.

MedDRA code (LLT): 10065822 · CTCAE v6.0 (NCI), original English text.

Radiation recall reaction (dermatologic)

Injury, poisoning and procedural complications
  1. G1Faint erythema or dry desquamation
  2. G2Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
  3. G3Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
  4. G4Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
  5. G5Death
Definition and note

DefinitionA finding of acute skin inflammatory reaction caused by drugs, especially chemotherapeutic agents, for weeks or months following radiotherapy. The inflammatory reaction is confined to the previously irradiated skin and the symptoms disappear after the removal of the pharmaceutical agent.

MedDRA code (LLT): 10037767 · CTCAE v6.0 (NCI), original English text.

Rectal anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a rectal anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065894 · CTCAE v6.0 (NCI), original English text.

Seroma

Injury, poisoning and procedural complications
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; simple aspiration indicated
  3. G3Symptomatic, elective invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding of tumor-like collection of serum in the tissues.

MedDRA code (LLT): 10040102 · CTCAE v6.0 (NCI), original English text.

Small intestinal anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of an anastomosis (surgical connection of two separate anatomic structures) in the small bowel.

MedDRA code (LLT): 10065892 · CTCAE v6.0 (NCI), original English text.

Spermatic cord anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a spermatic cord anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065897 · CTCAE v6.0 (NCI), original English text.

Stenosis of gastrointestinal stoma

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Symptomatic; IV fluids indicated <24 hrs; manual dilation at bedside
  3. G3Severely altered GI function; tube feeding, TPN or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of narrowing of the gastrointestinal stoma (surgically created opening on the surface of the body).

MedDRA code (LLT): 10065898 · CTCAE v6.0 (NCI), original English text.

Stomal ulcer

Injury, poisoning and procedural complications
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; elective operative intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the jejunal mucosal surface close to the anastomosis site following a gastroenterostomy procedure.

MedDRA code (LLT): 10042127 · CTCAE v6.0 (NCI), original English text.

Systemic post-immunization reaction

Injury, poisoning and procedural complicationsNew in v6.0
  1. G1Mild pain; erythema 2.5 - 5 cm; induration/swelling 2.5 - 5 cm; does not interfere with activity
  2. G2Moderate pain; erythema >5 - 10 cm; Induration/swelling >5 - 10 cm; lipodystrophy; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; erythema >10 cm; Induration/swelling >10 cm; necrosis; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a systemic manifestation that occurs after the injection of a substance with antigenic properties, administered to activate the immune system.

MedDRA code (LLT): 10089920 · CTCAE v6.0 (NCI), original English text.

Tissue injury

Injury, poisoning and procedural complicationsNew in v6.0
  1. G1Not applicable
  2. G2Limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Invasive intervention indicated; hospitalization; 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 finding of damage to an organ or tissue as a result of a procedure.

MedDRA code (LLT): 10080903 · CTCAE v6.0 (NCI), original English text.

Tracheal hemorrhage

Injury, poisoning and procedural complications
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the trachea.

MedDRA code (LLT): 10062548 · CTCAE v6.0 (NCI), original English text.

Tracheal obstruction

Injury, poisoning and procedural complications
  1. G1Partial asymptomatic obstruction on examination (e.g., visual, radiologic or endoscopic)
  2. G2Symptomatic (e.g., noisy airway breathing), no respiratory distress; medical intervention indicated (e.g., steroids); limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Stridor or respiratory distress; invasive intervention indicated (e.g., stent, laser); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the lumen of the trachea.

MedDRA code (LLT): 10044291 · CTCAE v6.0 (NCI), original English text.

Tracheostomy site bleeding

Injury, poisoning and procedural complications
  1. G1Minimal bleeding identified on clinical exam; intervention not indicated
  2. G2Moderate bleeding; medical intervention indicated
  3. G3Invasive intervention indicated; hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the tracheostomy site.

MedDRA code (LLT): 10065749 · CTCAE v6.0 (NCI), original English text.

Ureteric anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a ureteral anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065814 · CTCAE v6.0 (NCI), original English text.

Urethral anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a urethral anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065815 · CTCAE v6.0 (NCI), original English text.

Urostomy leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage of contents from a urostomy.

MedDRA code (LLT): 10065882 · CTCAE v6.0 (NCI), original English text.

Urostomy obstruction

Injury, poisoning and procedural complications
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; dilation or endoscopic repair or stent placement indicated
  3. G3Altered organ function (e.g., sepsis or hydronephrosis, or renal dysfunction); elective operative intervention indicated
  4. G4Life-threatening consequences; organ failure; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the urostomy.

MedDRA code (LLT): 10065883 · CTCAE v6.0 (NCI), original English text.

Urostomy site bleeding

Injury, poisoning and procedural complications
  1. G1Minimal bleeding identified on clinical exam; intervention not indicated
  2. G2Moderate bleeding; medical intervention indicated
  3. G3Invasive intervention indicated; hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the urostomy site.

MedDRA code (LLT): 10065748 · CTCAE v6.0 (NCI), original English text.

Urostomy stenosis

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Symptomatic but no hydronephrosis, sepsis, or renal dysfunction; dilation or endoscopic repair or stent placement indicated
  3. G3Symptomatic (e.g., hydronephrosis, or renal dysfunction); elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of narrowing of the opening of a urostomy.

MedDRA code (LLT): 10065885 · CTCAE v6.0 (NCI), original English text.

Uterine anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a uterine anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065886 · CTCAE v6.0 (NCI), original English text.

Uterine perforation

Injury, poisoning and procedural complications
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the uterine wall.

MedDRA code (LLT): 10046810 · CTCAE v6.0 (NCI), original English text.

Vaginal anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a vaginal anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065887 · CTCAE v6.0 (NCI), original English text.

Vas deferens anastomotic leak

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of leakage due to breakdown of a vas deferens anastomosis (surgical connection of two separate anatomic structures).

MedDRA code (LLT): 10065888 · CTCAE v6.0 (NCI), original English text.

Vascular access complication

Injury, poisoning and procedural complications
  1. G1TPA administration into line with no intent for systemic therapy indicated
  2. G2Device dislodgement, blockage, leak, or malposition; device replacement indicated
  3. G3Pulmonary embolism, deep vein or cardiac thrombosis; intervention indicated
  4. G4Life-threatening consequences with hemodynamic or neurologic instability
  5. G5Death
Definition and note

DefinitionA finding of a previously undocumented problem related to the vascular access site.

MedDRA code (LLT): 10062169 · CTCAE v6.0 (NCI), original English text.

Venous injury

Injury, poisoning and procedural complications
  1. G1Asymptomatic diagnostic finding; intervention not indicated
  2. G2Symptomatic (e.g., claudication); repair or revision not indicated
  3. G3Severe symptoms; repair or revision indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA finding of damage to a vein.

MedDRA code (LLT): 10047228 · CTCAE v6.0 (NCI), original English text.

Wound complication

Injury, poisoning and procedural complications
  1. G1Observation only; topical intervention indicated
  2. G2Bedside local care indicated
  3. G3Operative intervention indicated
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA finding of development of a new problem at the site of an existing wound.

Navigational notePrior to using this term consider Injury, poisoning and procedural complications: Wound dehiscence or Infections and infestations: Wound infection.

MedDRA code (LLT): 10053692 · CTCAE v6.0 (NCI), original English text.

Wound dehiscence

Injury, poisoning and procedural complications
  1. G1Incisional separation, intervention not indicated
  2. G2Incisional separation, local care (e.g., suturing) or medical intervention indicated (e.g., analgesic)
  3. G3Fascial disruption or dehiscence without evisceration; revision by operative intervention indicated
  4. G4Life-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicated
  5. G5Death
Definition and note

DefinitionA finding of separation of the approximated margins of a surgical wound.

Navigational noteConsider Infections and infestations: Wound infection.

MedDRA code (LLT): 10048031 · 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.