CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Renal and urinary disorders

The 25 CTCAE v6.0 adverse events in Renal and urinary disorders, with grades 1 to 5.

Acute kidney injury

Renal and urinary disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Hospitalization indicated
  4. G4Life-threatening consequences; dialysis indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by the acute loss of renal function (within 2 weeks).

Navigational noteConsider Investigations: Creatinine increased; Renal and urinary disorders: Tubulointerstitial nephritis.

MedDRA code (LLT): 10069339 · CTCAE v6.0 (NCI), original English text.

Bladder perforation

Renal and urinary disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; organ failure; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the bladder wall.

MedDRA code (LLT): 10063575 · CTCAE v6.0 (NCI), original English text.

Bladder spasm

Renal and urinary disorders
  1. G1Intervention not indicated
  2. G2Antispasmodics indicated
  3. G3Hospitalization indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sudden and involuntary contraction of the bladder wall.

MedDRA code (LLT): 10048994 · CTCAE v6.0 (NCI), original English text.

Chronic kidney disease

Renal and urinary disorders
  1. G1eGFR (estimated Glomerular Filtration Rate) or CrCl (creatinine clearance) <LLN - 60 ml/min/1.73 m2 or proteinuria 2+ present; urine protein/creatinine >0.5
  2. G2eGFR or CrCl <60 - 30 ml/min/1.73 m2
  3. G3eGFR or CrCl <30 - 15 ml/min/1.73 m2
  4. G4eGFR or CrCl <15 ml/min/1.73 m2; dialysis or renal transplant indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by loss of kidney function greater than three months duration.

MedDRA code (LLT): 10064848 · CTCAE v6.0 (NCI), original English text.

Cystitis noninfective

Renal and urinary disorders
  1. G1Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence
  2. G2Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Gross hematuria; transfusion, IV medications, or hospitalization indicated; elective invasive intervention indicated
  4. G4Life-threatening consequences; urgent invasive intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the bladder which is not caused by an infection of the urinary tract.

MedDRA code (LLT): 10063057 · CTCAE v6.0 (NCI), original English text.

Dysuria

Renal and urinary disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by painful urination.

Navigational noteIf associated with an infection, report the infection. For grades higher than Grade 1, consider Renal and urinary disorders: Bladder spasm, Cystitis noninfective; Infections and infestations: Urinary tract infection.

MedDRA code (LLT): 10013990 · CTCAE v6.0 (NCI), original English text.

Glomerulonephritis

Renal and urinary disordersNew in v6.0
  1. G1Asymptomatic; laboratory findings only
  2. G2Declining glomerular filtration rate (GFR); edema; hypertension; oral management indicated
  3. G3IV therapy indicated; immunosuppressant indicated; 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; renal replacement therapy
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the glomerulus, usually based on renal biopsy.

MedDRA code (LLT): 10018364 · CTCAE v6.0 (NCI), original English text.

Glucosuria

Renal and urinary disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate glucose in the urine.

MedDRA code (LLT): 10068405 · CTCAE v6.0 (NCI), original English text.

Hematuria

Renal and urinary disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; urinary catheter or bladder irrigation indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Gross hematuria; transfusion, IV medications, or hospitalization indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent invasive intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate blood in the urine.

MedDRA code (LLT): 10019450 · CTCAE v6.0 (NCI), original English text.

Hemoglobinuria

Renal and urinary disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate the presence of free hemoglobin in the urine.

Navigational noteReport underlying AE if > Grade 1.

MedDRA code (LLT): 10019489 · CTCAE v6.0 (NCI), original English text.

Nephrotic syndrome

Renal and urinary disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3IV therapy indicated; 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; renal replacement therapy; anasarca
  5. G5Death
Definition and note

DefinitionA disorder characterized by symptoms that include severe edema, proteinuria, and hypoalbuminemia; it is indicative of renal dysfunction.

MedDRA code (LLT): 10029164 · CTCAE v6.0 (NCI), original English text.

Nocturia

Renal and urinary disordersNew in v6.0
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the need to get up at night on a regular basis to urinate.

MedDRA code (LLT): 10029446 · CTCAE v6.0 (NCI), original English text.

Renal and urinary disorders - Other, specify

Renal and urinary 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): 10038359 · CTCAE v6.0 (NCI), original English text.

Renal calculi

Renal and urinary disorders
  1. G1Asymptomatic or mild symptoms; occasional use of nonprescription analgesics indicated
  2. G2Symptomatic; oral antiemetics indicated; around the clock nonprescription analgesics or any oral narcotic analgesics indicated
  3. G3Hospitalization indicated; IV intervention (e.g., analgesics, antiemetics); elective invasive intervention indicated
  4. G4Life-threatening consequences; urgent invasive intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by the formation of crystals/kidney stones in the pelvis of the kidney.

MedDRA code (LLT): 10038385 · CTCAE v6.0 (NCI), original English text.

Renal colic

Renal and urinary disorders
  1. G1Mild pain not interfering with activity; nonprescription medication indicated
  2. G2Moderate pain; prescription medication indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Hospitalization indicated; 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 paroxysmal and severe flank marked discomfort radiating to the inguinal area. Often, the cause is the passage of crystals/kidney stones.

MedDRA code (LLT): 10038419 · CTCAE v6.0 (NCI), original English text.

Renal hemorrhage

Renal and urinary disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Analgesics and hematocrit monitoring indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the kidney.

MedDRA code (LLT): 10038463 · CTCAE v6.0 (NCI), original English text.

Tubulointerstitial nephritis

Renal and urinary disordersNew in v6.0
  1. G1Laboratory findings without increase in creatinine
  2. G2Increase in creatinine; oral management indicated with steroid
  3. G3IV therapy indicated; 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

DefinitionA disorder characterized by inflammation of the renal tubule and surrounding tissues.

MedDRA code (LLT): 10048302 · CTCAE v6.0 (NCI), original English text.

Urinary fistula

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

DefinitionA disorder characterized by an abnormal communication between any part of the urinary system and another organ or anatomic site.

MedDRA code (LLT): 10065368 · CTCAE v6.0 (NCI), original English text.

Urinary frequency

Renal and urinary disorders
  1. G1Present
  2. G2Medical management indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by urination at short intervals.

MedDRA code (LLT): 10046539 · CTCAE v6.0 (NCI), original English text.

Urinary incontinence

Renal and urinary disorders
  1. G1Occasional (e.g., with coughing, sneezing, etc.), pads not indicated
  2. G2Spontaneous; pads indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Intervention indicated (e.g., clamp, collagen injections); operative intervention indicated; 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 inability to control the flow of urine from the bladder.

MedDRA code (LLT): 10046543 · CTCAE v6.0 (NCI), original English text.

Urinary retention

Renal and urinary disorders
  1. G1Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual
  2. G2Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated
  3. G3Elective invasive intervention indicated; substantial loss of affected kidney function or mass
  4. G4Life-threatening consequences; organ failure; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by accumulation of urine within the bladder because of the inability to urinate.

MedDRA code (LLT): 10046555 · CTCAE v6.0 (NCI), original English text.

Urinary tract obstruction

Renal and urinary disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic but no hydronephrosis, sepsis, or renal dysfunction; urethral dilation, urinary or suprapubic catheter indicated
  3. G3Altered organ function (e.g., hydronephrosis or renal dysfunction); invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of contents of the urinary tract.

MedDRA code (LLT): 10061574 · CTCAE v6.0 (NCI), original English text.

Urinary tract pain

Renal and urinary 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 urinary tract.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10062225 · CTCAE v6.0 (NCI), original English text.

Urinary urgency

Renal and urinary disorders
  1. G1Present
  2. G2Medical management indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sudden compelling urge to urinate.

MedDRA code (LLT): 10046593 · CTCAE v6.0 (NCI), original English text.

Urine discoloration

Renal and urinary disorders
  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a change in the color of the urine.

MedDRA code (LLT): 10046628 · 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.