CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Investigations

The 40 CTCAE v6.0 adverse events in Investigations, with grades 1 to 5.

Activated partial thromboplastin time prolonged

Investigations
  1. G1>ULN - 1.5 x ULN
  2. G2>1.5 - 2.5 x ULN
  3. G3>2.5 x ULN; bleeding
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results in which the partial thromboplastin time is found to be greater than the control value. As a possible indicator of coagulopathy, a prolonged partial thromboplastin time (PTT) may occur in a variety of diseases and disorders, both primary and related to treatment.

MedDRA code (LLT): 10000636 · CTCAE v6.0 (NCI), original English text.

Alanine aminotransferase increased

Investigations
  1. G1>ULN - 3.0 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
  2. G2>3.0 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 2.0 x baseline if baseline was >ULN
  3. G3>5.0 - 20.0 x ULN if baseline was normal or less than normal; >2.0 - 4.0 x baseline if baseline was >ULN up to 5 x ULN
  4. G4>20.0 x ULN if baseline was normal or less than normal; >4.0 x baseline if baseline was >ULN
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.

Navigational noteConsider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.

MedDRA code (LLT): 10001551 · CTCAE v6.0 (NCI), original English text.

Alkaline phosphatase increased

Investigations
  1. G1>Baseline and ULN
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase (ALP) in a blood specimen.

MedDRA code (LLT): 10001675 · CTCAE v6.0 (NCI), original English text.

Aspartate aminotransferase increased

Investigations
  1. G1>ULN - 3.0 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
  2. G2>3.0 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 2.0 x baseline if baseline was >ULN
  3. G3>5.0 - 20.0 x ULN if baseline was normal or less than normal; >2.0 - 4.0 x baseline if baseline was >ULN up to 5 x ULN
  4. G4>20.0 x ULN if baseline was normal or less than normal; >4.0 x baseline if baseline was >ULN
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.

Navigational noteConsider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.

MedDRA code (LLT): 10003481 · CTCAE v6.0 (NCI), original English text.

Blood antidiuretic hormone abnormal

Investigations
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Hospitalization indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate abnormal levels of antidiuretic hormone (ADH) in the blood specimen.

MedDRA code (LLT): 10005332 · CTCAE v6.0 (NCI), original English text.

Blood bicarbonate decreased

Investigations
  1. G1<LLN and no intervention initiated
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in levels of bicarbonate in a venous blood specimen.

Navigational noteConsider Metabolism and nutrition disorders: Acidosis, Alkalosis.

MedDRA code (LLT): 10005359 · CTCAE v6.0 (NCI), original English text.

Blood bilirubin increased

Investigations
  1. G1>ULN - 1.5 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
  2. G2>1.5 - 3.0 x ULN if baseline was normal or less than normal; >1.5 - 2.5 x baseline if baseline was >ULN
  3. G3>3.0 - 10.0 x ULN if baseline was normal or less than normal; >2.5 - 10.0 x baseline if baseline was >ULN
  4. G4>10.0 x ULN if baseline was normal or less than normal; >10.0 x baseline if baseline was >ULN
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an abnormally high level of total bilirubin in the blood. Excess bilirubin is associated with jaundice.

Navigational noteConsider Hepatobiliary disorders: Hepatic failure. Report Autoimmune hepatitis under Hepatobiliary disorders: Other, specify.

MedDRA code (LLT): 10005364 · CTCAE v6.0 (NCI), original English text.

Blood corticotrophin decreased

Investigations
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Hospitalization indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in the expected levels of corticotrophin (ACTH) in a blood specimen.

MedDRA code (LLT): 10005452 · CTCAE v6.0 (NCI), original English text.

Blood gonadotrophin abnormal

Investigations
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate abnormal levels of gonadotrophin hormone in a blood specimen.

MedDRA code (LLT): 10005561 · CTCAE v6.0 (NCI), original English text.

Blood lactate dehydrogenase increased

Investigations
  1. G1>ULN
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate increased levels of lactate dehydrogenase (LDH) in the blood specimen.

MedDRA code (LLT): 10005630 · CTCAE v6.0 (NCI), original English text.

Blood prolactin abnormal

Investigations
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate symptoms; 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 finding based on laboratory test results that indicate abnormal levels of prolactin hormone in a blood specimen.

MedDRA code (LLT): 10005778 · CTCAE v6.0 (NCI), original English text.

Carbon monoxide diffusing capacity decreased

Investigations
  1. G13 - 5 units below LLN if no baseline available; for follow-up, a decrease of 3 - 5 units (ml/min/mmHg) below the baseline value; asymptomatic and intervention not indicated
  2. G26 - 8 units below LLN if no baseline available; for follow-up, an asymptomatic decrease of >5 - 8 units (ml/min/mmHg) below the baseline value; symptomatic and intervention not indicated
  3. G3Asymptomatic decrease of >8 units drop; >5 units drop along with the presence of pulmonary symptoms (e.g., >Grade 2 hypoxia or >Grade 2 dyspnea); intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on lung function test results that indicate a decrease in the lung capacity to absorb carbon monoxide (DLCO or TLCO).

Navigational noteConsider Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.

MedDRA code (LLT): 10065906 · CTCAE v6.0 (NCI), original English text.

CD4 lymphocytes decreased

Investigations
  1. G1<LLN - 500/mm3; <LLN - 0.5 x 10^9/L
  2. G2<500 - 200/mm3; <0.5 - 0.2 x 10^9/L
  3. G3<200 - 50/mm3; <0.2 - 0.05 x 10^9/L
  4. G4<50/mm3; <0.05 x 10^9/L
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in levels of CD4 lymphocytes in a blood specimen.

MedDRA code (LLT): 10007839 · CTCAE v6.0 (NCI), original English text.

Cholesterol high

Investigations
  1. G1>ULN - 300 mg/dL; >ULN - 7.75 mmol/L
  2. G2>300 - 400 mg/dL; >7.75 - 10.34 mmol/L
  3. G3>400 - 500 mg/dL; >10.34 - 12.92 mmol/L
  4. G4>500 mg/dL; >12.92 mmol/L
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate higher than normal levels of cholesterol in a blood specimen.

MedDRA code (LLT): 10008661 · CTCAE v6.0 (NCI), original English text.

Creatinine clearance decreased

InvestigationsNew in v6.0
  1. G1Not applicable
  2. G226 - 49 ml/min
  3. G310 - 25 ml/min
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in creatinine clearance (CrCl) in a 24-hour urine collection.

Navigational noteReport Grade 4 and 5 as Renal and urinary disorders: Acute kidney injury or Chronic kidney disease.

MedDRA code (LLT): 10011363 · CTCAE v6.0 (NCI), original English text.

Creatinine increased

Investigations
  1. G1>ULN - 1.5 x ULN
  2. G2>1.5 - 3.0 x baseline if baseline is below LLN; >1.5 - 3.0 x ULN
  3. G3>3.0 x baseline if baseline is below LLN; >3.0 - 6.0 x ULN
  4. G4>6.0 x ULN
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.

Navigational noteConsider Renal and urinary disorders: Acute kidney injury, Glomerulonephritis, Tubulointerstitial nephritis.

MedDRA code (LLT): 10011368 · CTCAE v6.0 (NCI), original English text.

Electrocardiogram QT corrected interval prolonged

Investigations
  1. G1Average QTc 450 - 480 ms
  2. G2Average QTc 481 - 500 ms
  3. G3Average QTc >500 ms; >60 ms change from baseline
  4. G4Life-threatening consequences; Torsade de pointes; polymorphic ventricular tachycardia
  5. G5Not applicable
Definition and note

DefinitionA finding of a cardiac dysrhythmia characterized by an abnormally long corrected QT interval.

Navigational noteConsider Cardiac disorders: Ventricular arrhythmia, Ventricular fibrillation, Ventricular tachycardia.

MedDRA code (LLT): 10014383 · CTCAE v6.0 (NCI), original English text.

Fibrinogen decreased

Investigations
  1. G1<1.0 - 0.75 x LLN; if abnormal, <25% decrease from baseline
  2. G2<0.75 - 0.5 x LLN; if abnormal, 25 - <50% decrease from baseline
  3. G3<0.5 - 0.25 x LLN; if abnormal, 50 - <75% decrease from baseline
  4. G4<0.25 x LLN; if abnormal, 75% decrease from baseline; absolute value <50 mg/dL
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an decrease in levels of fibrinogen in a blood specimen.

MedDRA code (LLT): 10016596 · CTCAE v6.0 (NCI), original English text.

Forced expiratory volume decreased

Investigations
  1. G1FEV1% (percentages of observed FEV1 and FVC related to their respective predicted values) 99 - 70% predicted; Global Lung Function Initiative (GLI) Z-score -1.65 to -2.5
  2. G2FEV1% 60 - 69%; GLI Z-score <-2.5 to -4
  3. G3FEV1% 50 - 59%; GLI Z-score <-4
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on test results that indicate a relative decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.

Navigational noteConsider Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.

MedDRA code (LLT): 10016987 · CTCAE v6.0 (NCI), original English text.

GGT increased

Investigations
  1. G1>ULN - 2.5 x ULN if baseline was normal or less than normal; 1.0 - 1.5 x baseline if baseline was >ULN
  2. G2>2.5 - 5.0 x ULN if baseline was normal or less than normal; >1.5 - 3.0 x baseline if baseline was >ULN
  3. G3>5.0 - 20.0 x ULN if baseline was normal or less than normal; >3.0 - 10.0 x baseline if baseline was >ULN
  4. G4>20.0 x ULN if baseline was normal or less than normal; >10.0 x baseline if baseline was >ULN
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate higher than normal levels of the enzyme gamma-glutamyltransferase in the blood specimen. GGT (gamma-glutamyltransferase ) catalyzes the transfer of a gamma glutamyl group from a gamma glutamyl peptide to another peptide, amino acids or water.

MedDRA code (LLT): 10056910 · CTCAE v6.0 (NCI), original English text.

Growth hormone abnormal

Investigations
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention 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 finding based on laboratory test results that indicate abnormal levels of growth hormone (GH) in a biological specimen.

MedDRA code (LLT): 10018748 · CTCAE v6.0 (NCI), original English text.

Haptoglobin decreased

Investigations
  1. G1<LLN
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an decrease in levels of haptoglobin (HP) in a blood specimen.

MedDRA code (LLT): 10019150 · CTCAE v6.0 (NCI), original English text.

HDL decreased

InvestigationsNew in v6.0
  1. G1<LLN
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in HDL in a blood specimen.

MedDRA code (LLT): 10019186 · CTCAE v6.0 (NCI), original English text.

Hemoglobin increased

Investigations
  1. G1Increase in >0 - 2 g/dL above ULN
  2. G2Increase in >2 - 4 g/dL above ULN
  3. G3Increase in >4 g/dL above ULN
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate increased levels of hemoglobin (Hgb) above normal.

MedDRA code (LLT): 10055599 · CTCAE v6.0 (NCI), original English text.

INR increased

Investigations
  1. G1>1.2 - 1.5; >1 - 1.5 x baseline if on anticoagulation; monitoring only indicated
  2. G2>1.5 - 2.5; >1.5 - 2.5 x baseline if on anticoagulation; dose adjustment indicated
  3. G3>2.5; >2.5 x baseline if on anticoagulation; bleeding
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in the ratio of the patient's prothrombin time (PT) to a control sample in the blood.

MedDRA code (LLT): 10022402 · CTCAE v6.0 (NCI), original English text.

Investigations - Other, specify

Investigations
  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): 10022891 · CTCAE v6.0 (NCI), original English text.

LDL increased

InvestigationsNew in v6.0
  1. G1>ULN
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in LDL in a blood specimen.

MedDRA code (LLT): 10024057 · CTCAE v6.0 (NCI), original English text.

Lipase increased

Investigations
  1. G1>ULN - 1.5 x ULN
  2. G2>1.5 - 3.0 x ULN; >3.0 - 5.0 x ULN and asymptomatic
  3. G3>3.0 - 5.0 x ULN with signs or symptoms; >5.0 x ULN and asymptomatic
  4. G4>5.0 x ULN and with signs or symptoms
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in the level of lipase in a biological specimen.

Navigational noteConsider Gastrointestinal disorders: Pancreatitis.

MedDRA code (LLT): 10024574 · CTCAE v6.0 (NCI), original English text.

Lymphocyte count increased

Investigations
  1. G1Not applicable
  2. G2>4000/mm3 - 20,000/mm3
  3. G3>20,000/mm3
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an abnormal increase in the number of lymphocytes in the blood, effusions or bone marrow.

MedDRA code (LLT): 10025258 · CTCAE v6.0 (NCI), original English text.

Neutrophil count decreased

Investigations
  1. G1<1500 - 1000/mm3; <1.5 - 1.0 x 10^9/L
  2. G2<1000 - 500/mm3; <1.0 - 0.5 x 10^9/L
  3. G3<500 - 100/mm3; <0.5 - 0.1 x 10^9/L
  4. G4<100/mm3; <0.1 x 10^9/L
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in number of neutrophils (ANC) in a blood specimen.

MedDRA code (LLT): 10029366 · CTCAE v6.0 (NCI), original English text.

Neutrophil count increased

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

DefinitionA finding based on laboratory test results that indicate an increase in number of neutrophils (ANC) in a blood specimen.

MedDRA code (LLT): 10029368 · CTCAE v6.0 (NCI), original English text.

Serum amylase increased

Investigations
  1. G1>ULN - 1.5 x ULN
  2. G2>1.5 - 2.0 x ULN; >2.0 - 5.0 x ULN and asymptomatic or with mild signs or symptoms
  3. G3>2.0 - 5.0 x ULN with moderate or severe signs or symptoms; >5.0 x ULN and asymptomatic
  4. G4>5.0 x ULN and with signs or symptoms
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate an increase in the levels of amylase in a serum specimen.

Navigational noteConsider Gastrointestinal disorders: Pancreatitis.

MedDRA code (LLT): 10040139 · CTCAE v6.0 (NCI), original English text.

Thyroid stimulating hormone increased

Investigations
  1. G1TSH increased and no intervention indicated
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an increase in thyroid stimulating hormone (TSH).

Navigational noteIf intervention initiated or symptomatic, report as Endocrine disorders: Hypothyroidism.

MedDRA code (LLT): 10043770 · CTCAE v6.0 (NCI), original English text.

Urinary protein increased

InvestigationsNew in v6.0
  1. G1Adult: 1+ proteinuria; urinary protein ≥ULN - <1.0 g/24 hrs; P/C <1; Pediatric: 1 + proteinuria
  2. G2Adult: 2+ and 3+ proteinuria; urinary protein 1.0 - <3.5 g/24 hrs; P/C 1 - 3.5; Pediatric: Urine P/C (Protein/Creatinine) ratio 0.5 - 1.9; 2 - 3+ proteinuria
  3. G3Adult: Urinary protein >=3.5 g/24 hrs; 4+ proteinuria; P/C >3.5; Pediatric: Urine P/C (Protein/Creatinine) ratio >1.9, 4+ proteinuria
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate the presence of excessive protein in the urine. It is predominantly albumin, but also globulin.

Navigational note24-hour urine collection takes precedence over dipstick.

MedDRA code (LLT): 10046553 · CTCAE v6.0 (NCI), original English text.

Urine output decreased

Investigations
  1. G1Not applicable
  2. G2Not applicable
  3. G3Adult: Oliguria (<80 ml in 8 hr); Infants: <1 ml/kg/hour; Children: <0.5 ml/kg/hour
  4. G4Adult: Anuria (<240 ml in 24 hr); Pediatric: No urine output over 12 hours
  5. G5Not applicable
Definition and note

DefinitionA finding based on test results that indicate urine production is less relative to previous output.

MedDRA code (LLT): 10059895 · CTCAE v6.0 (NCI), original English text.

Vital capacity abnormal

Investigations
  1. G190 - 75% of predicted value
  2. G2<75 - 50% of predicted value; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3<50% of predicted value; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on pulmonary function test results that indicate an abnormal vital capacity (VC) (amount of exhaled after a maximum inhalation) when compared to the predicted value.

Navigational noteConsider Investigations: Forced expiratory volume decreased; Respiratory, thoracic and mediastinal disorders: Dyspnea, Respiratory failure.

MedDRA code (LLT): 10047580 · CTCAE v6.0 (NCI), original English text.

Vitamin D decreased

InvestigationsNew in v6.0
  1. G1Vitamin D decreased <LLN
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a low concentration of Vitamin D in the blood.

MedDRA code (LLT): 10062189 · CTCAE v6.0 (NCI), original English text.

Weight gain

Investigations
  1. G15 - <10% from baseline
  2. G210 - <20% from baseline
  3. G3>=20% from baseline
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding characterized by an unexpected or abnormal increase in overall body weight; for pediatrics, percentages represent the absolute increase above that expected from the baseline growth curve (not change in growth percentiles).

MedDRA code (LLT): 10047896 · CTCAE v6.0 (NCI), original English text.

Weight loss

Investigations
  1. G15 - <10% from baseline; intervention not indicated
  2. G210 - <20% from baseline; nutritional support indicated
  3. G3>=20% from baseline; tube feeding or TPN indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve.

MedDRA code (LLT): 10047900 · CTCAE v6.0 (NCI), original English text.

White blood cell decreased

Investigations
  1. G1<LLN - 3000/mm3; <LLN - 3.0 x 10^9/L
  2. G2<3000 - 2000/mm3; <3.0 - 2.0 x 10^9/L
  3. G3<2000 - 1000/mm3; <2.0 - 1.0 x 10^9/L
  4. G4<1000/mm3; <1.0 x 10^9/L
  5. G5Not applicable
Definition and note

DefinitionA finding based on laboratory test results that indicate a decrease in number of white blood cells (WBC) in a blood specimen.

MedDRA code (LLT): 10049182 · CTCAE v6.0 (NCI), original English text.

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