Common Terminology Criteria for Adverse Events …

1 Common Terminology Criteria for Adverse Events (CTCAE) Version Published: May 28, 2009 ( : Jun. 14, 2010) JCOG CTCAE - JCOG CTCAE MedDRA/J - 2011 4 25 1 CTCAE - JCOG CTCAE MedDRA/J 2011 4 25 Common Terminology Criteria for Adverse Events (CTCAE) Publish Date: May 28, 2009 ( : Jun. 14, 2010) JCOG CTCAE - JCOG CTCAE MedDRA/J - 2011 4 25 Quick Reference NCI AE AE Grade Components and Organization SOC MedDRA SOC : System Organ Class SOC SOC CTCAE MedDRA Primary SOC SOC Grade CTCAE CTCAE Terms AE AE CTCAE MedDRA LLT( ) Definition AE Grades Grade AE CTCAE Grade 1 5 AE Grade 1 ; , ; ; Grade 2 ; / / ; * Grade 3.

2 ; / ; ** Grade 4 ; Grade 5 AE Grade ; - Grade AE Grade AE Grade 5 Grade 5 AE Grade 5 2 CTCAE - JCOG CTCAE MedDRA/J 2011 4 25 Activities of Daily Living (ADL) * instrumental ADL ** self care ADL CTCAE MedDRA MedDRA the MedDRA MSSO Web site MedDRA MedDRA/J 3 CTCAE - JCOG CTCAE MedDRA/J 2011 4 25 JCOG CTCAE - JCOG JCOG CTCAE - JCOG 2009 5 National Cancer Institute NCI Cancer Therapy Evaluation Program CTEP Common Terminology Criteria for Adverse Events (CTCAE) CTCAE JCOG CTEP CTCAE URL #ctc_40 20 -6 JCOG Japan Clinical Oncology Group/ / CTCAE Steering Committee JCOG 2009 12 PDF Excel JCOG JCOG Excel PDF Grade MedDRA SOC CTCAE MedDRA/J CTCAE Medical Dictionary for Regulatory Activities MedDRA CTCAE MedDRA MedDRA MedDRA/J CTCAE Term CTCAE - JCOG CTCAE - JCOG

3 MedDRA/J MedDRA/J MedDRA/J CTCAE JCOG JCOG CTCAE - JCOG CTCAE MedDRA MedDRA/J CTCAE - JCOG CTCAE MedDRA MedDRA/J MedDRA/J Grading nearest match Nearest match Grade Grade Grade 3 Grade 3 Grade Grade indicated Grade what was actually done what should be done 4 CTCAE - JCOG CTCAE MedDRA/J 2011 4 25 medical opinion grading CTCAE AE Term Definition A disorder characterized by A disorder characterized by A disorder characterized by or ; or 1 or or.

4 / or / Grade 3 / disabling CTCAE disabling / Activities of Daily Living ADL self care ADL instrumental ADL Grade Grade JCOG JCOG 10002272 CTCAE Grade 3 Grade 4 JCOG CTCAE Grade 3 g/dL; mmol/L; 80 65 g/L Grade 4 g/dL; mmol/L; 65 g/L 10020943 CTCAE Grade 4 JCOG CTCAE Grade 4 5 CTCAE - JCOG CTCAE MedDRA/J 2011 4 25 Grade 4 10021018 CTCAE Grade 2 JCOG CTCAE Grade 2 Grade 2 Grade 3 mmol/L Grade 4 mmol/L CTCAE LLN ULN ANC AGC pRBC TPN IVR CNS CTCAE - JCOG CTCAE MedDRA MedDRA/J 2009 12 28 CTCAE MedDRA/J 2010 2 1 CTCAE MedDRA/J CTCAE 2010 9 11 CTCAE MedDRA/J CTCAE 2011 4 25 CTCAE MedDRA/J CTCAE JCOG 6 CTCAE - JCOG CTCAE MedDRA/J 2011 4 25

5 CTCAE Steering Committee/ JCOG JCOG JMO MedDRA/J JCOG JCOG / JCOG JCOG JCOG CTCAE - JCOG CTCAE MedDRA/J - 2011 4 25 CTCAE CodeCTCAE CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 CTCAE AE TermDefinition 10002272 Anemia g/dL; mmol/L; LLN-100 g/L g/dL; ; 100-80g/L ; mmol/L; 80 g/L; ; 100 mL JCOG 10048580 Bone marrowhypocellular 25% 25- 50% 50- 75% 2 10013442 Disseminatedintravascularcoagulation - ; 10016288 Febrileneutropenia --ANC 1,000/mm3 , , 1 C 101 F , 1 38 C F ; ANC 1,000/mm3 , , 1 C 101 F , 1 38 C F 10019491 Hemolysis : ; DAT;Coomb's; ; , 2g/dL.

6 10019515 Hemolytic uremicsyndrome - : , :CNS , / , 10024378 Leukocytosis -- 100,000 /mm3 ; 10025182 Lymph node pain ; ; -- 10041633 Spleen disorder : ; - ; 10043648 Thromboticthrombocytopenicpurpura - : , :CNS , / , CNS 10005329 Blood andlymphatic systemdisorders - Other,specify , ; ; ; / / ; , ; ; / ; ; 10051592 Acute coronarysyndrome - , ; ; , , , , Blood and lymphatic system disorders Cardiac disorders1 / 57 JCOG CTCAE - JCOG CTCAE MedDRA/J - 2011 4 25 CTCAE CodeCTCAE CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 CTCAE AE TermDefinition 10061589 Aortic valvedisease ; ; ; ; : , 10003586 Asystole ; , -- ; 10003658 Atrial fibrillation.

7 P 10003662 Atrial flutter , , , : ; 200-300 / 10003673 Atrioventricularblock complete - , , : ; AV 10003674 Atrioventricularblock first degree , ---AV 200 PR 10007515 Cardiac arrest --- ; 10008481 Chest pain -cardiac ; ; -- 10010276 Conductiondisorder ; ; ; 10010783 Constrictivepericarditis -- , 10019279 Heart failure , : BNP ; ; : 10069501 Left ventricularsystolicdysfunction -- ; 10061532 Mitral valvedisease ; ; ; ; : , 10027786 Mobitz (type) IIatrioventricularblock 2.

8 PR AV 2 / 57 JCOG CTCAE - JCOG CTCAE MedDRA/J - 2011 4 25 CTCAE CodeCTCAE CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 CTCAE AE TermDefinition 10027787 Mobitz type I 1 , ; , , : ; PR AV 10028596 Myocardialinfarction - , , ; ; ; ; 10028606 Myocarditis , : BNP ; ; : 10033557 Palpitations ; --- 10034040 Paroxysmal atrialtachycardia , ; ; ; 150-250 / 10034474 Pericardialeffusion - ; 10053565 Pericardialtamponade --- ; 10034484 Pericarditis , : : : ; 10061541 Pulmonary valvedisease ; ; ; ; : , 10038748 Restrictivecardiomyopathy -- , 10058597 Right ventriculardysfunction , : BNP.

9 10040639 Sick sinussyndrome , ; ; 10040741 Sinus bradycardia , , ; ; 60 / 10040752 Sinus tachycardia , ; -- 100 / 10042604 Supraventriculartachycardia , ; 100 / 10061389 Tricuspid valvedisease ; ; ; ; : , 3 / 57 JCOG CTCAE - JCOG CTCAE MedDRA/J - 2011 4 25 CTCAE CodeCTCAE CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 CTCAE AE TermDefinition 10047281 Ventriculararrhythmia , ; ; 10047290 Ventricularfibrillation.