CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Hepatobiliary disorders

The 20 CTCAE v6.0 adverse events in Hepatobiliary disorders, with grades 1 to 5.

Bile duct stenosis

Hepatobiliary disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; IV fluids indicated <24 hrs
  3. G3Severely altered GI function; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the bile duct.

MedDRA code (LLT): 10051341 · CTCAE v6.0 (NCI), original English text.

Biliary fistula

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the bile ducts and another organ or anatomic site.

MedDRA code (LLT): 10004665 · CTCAE v6.0 (NCI), original English text.

Biliary obstruction

Hepatobiliary disordersNew in v6.0
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; IV fluids indicated <24 hrs
  3. G3Symptomatic and severely altered GI function; hospitalization indicated; non-emergent 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 normal flow of bile.

MedDRA code (LLT): 10084247 · CTCAE v6.0 (NCI), original English text.

Budd-Chiari syndrome

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Medical management indicated
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; asterixis; mild encephalopathy
  4. G4Life-threatening consequences; moderate to severe encephalopathy; coma
  5. G5Death
Definition and note

DefinitionA disorder characterized by occlusion of the hepatic veins and typically presents with abdominal pain, ascites and hepatomegaly.

MedDRA code (LLT): 10006537 · CTCAE v6.0 (NCI), original English text.

Cholecystitis

Hepatobiliary disorders
  1. G1Not applicable
  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 disorder characterized by inflammation involving the gallbladder. It may be associated with the presence of gallstones.

MedDRA code (LLT): 10008612 · CTCAE v6.0 (NCI), original English text.

Gallbladder fistula

Hepatobiliary disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the gallbladder and another organ or anatomic site.

MedDRA code (LLT): 10017631 · CTCAE v6.0 (NCI), original English text.

Gallbladder necrosis

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Life-threatening consequences; urgent invasive intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the gallbladder.

MedDRA code (LLT): 10059446 · CTCAE v6.0 (NCI), original English text.

Gallbladder obstruction

Hepatobiliary disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; IV fluids indicated <24 hrs
  3. G3Symptomatic and severely altered GI function; hospitalization indicated; non-emergent 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 gallbladder.

MedDRA code (LLT): 10017636 · CTCAE v6.0 (NCI), original English text.

Gallbladder pain

Hepatobiliary 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 gallbladder region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10017638 · CTCAE v6.0 (NCI), original English text.

Gallbladder perforation

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the gallbladder wall.

MedDRA code (LLT): 10017639 · CTCAE v6.0 (NCI), original English text.

Hepatic failure

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Asterixis; mild encephalopathy; drug-induced liver injury (DILI); limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; moderate to severe encephalopathy; coma
  5. G5Death
Definition and note

DefinitionA disorder characterized by the inability of the liver to metabolize chemicals in the body. Laboratory test results reveal abnormal plasma levels of ammonia, bilirubin, lactic dehydrogenase, alkaline phosphatase, aminotransferase, and/or prolongation of prothrombin time (INR.) Drug-induced liver injury (DILI) as defined by Hy's Law.

MedDRA code (LLT): 10019663 · CTCAE v6.0 (NCI), original English text.

Hepatic hemorrhage

Hepatobiliary disorders
  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 liver.

MedDRA code (LLT): 10019678 · CTCAE v6.0 (NCI), original English text.

Hepatic necrosis

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Life-threatening consequences; urgent invasive intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the hepatic parenchyma.

MedDRA code (LLT): 10019692 · CTCAE v6.0 (NCI), original English text.

Hepatic pain

Hepatobiliary 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 liver region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10019705 · CTCAE v6.0 (NCI), original English text.

Hepatitis

Hepatobiliary disordersNew in v6.0
  1. G1Not applicable
  2. G2Moderate symptoms; medical intervention indicated
  3. G3Symptomatic liver dysfunction; compensated cirrhosis; hospitalization or prolongation of existing hospitalization indicated
  4. G4Life-threatening consequences; severe decompensated liver function (e.g., coagulopathy, encephalopathy, coma)
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the liver.

Navigational noteConsider Infections and infestations: Hepatitis viral, Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.

MedDRA code (LLT): 10019717 · CTCAE v6.0 (NCI), original English text.

Hepatobiliary disorders - Other, specify

Hepatobiliary 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): 10019805 · CTCAE v6.0 (NCI), original English text.

Perforation bile duct

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the wall of the extrahepatic or intrahepatic bile duct.

MedDRA code (LLT): 10034405 · CTCAE v6.0 (NCI), original English text.

Portal hypertension

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Decreased portal vein flow
  3. G3Reversal/retrograde portal vein flow; associated with varices and/or ascites
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an increase in blood pressure in the portal venous system.

MedDRA code (LLT): 10036200 · CTCAE v6.0 (NCI), original English text.

Portal vein thrombosis

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Intervention not indicated
  3. G3Medical intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by the formation of a thrombus (blood clot) in the portal vein.

MedDRA code (LLT): 10036206 · CTCAE v6.0 (NCI), original English text.

Sinusoidal obstruction syndrome

Hepatobiliary disorders
  1. G1Not applicable
  2. G2Blood bilirubin 2 - 5 mg/dL; minor interventions required (i.e., blood product, diuretic, oxygen)
  3. G3Blood bilirubin >5 mg/dL; coagulation modifier indicated (e.g., defibrotide); reversal of flow on ultrasound
  4. G4Life-threatening consequences (e.g., ventilatory support, dialysis, plasmapheresis, peritoneal drainage)
  5. G5Death
Definition and note

DefinitionA disorder characterized by severe hepatic injury as a result of the blood vessels of the liver becoming inflamed and/or blocked.

MedDRA code (LLT): 10063675 · 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.