Common Terminology Criteria for Adverse Events (CTCAE) …

1 Common Terminology Criteria for Adverse Events (CTCAE) Version Published: May 28, 2009 ( : Jun. 14, 2010) jcog CTCAE - jcog CTCAE MedDRA/J - 2010 9 11 1 CTCAE - jcog CTCAE MedDRA/J 2010 9 11 Common Terminology Criteria for Adverse Events (CTCAE) Publish Date: May 28, 2009 ( : Jun. 14, 2010) jcog CTCAE - jcog CTCAE MedDRA/J - 2010 9 11 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 , ; ; / ; ** Grade 4 ; Grade 5 AE Grade.

2 - Grade AE Grade AE Grade 5 Grade 5 AE Grade 5 2 CTCAE - jcog CTCAE MedDRA/J 2010 9 11 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 2010 9 11 jcog CTCAE - jcog jcog CTCAE - jcog 2009 5 National Cancer Institute NCI Cancer Therapy Evaluation Program CTEP Common Terminology Criteria for Adverse Events (CTCAE)

3 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 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

4 Indicated Grade what was actually done what should be done 4 CTCAE - jcog CTCAE MedDRA/J 2010 9 11 medical opinion grading CTCAE AE Term Definition A disorder characterized by A disorder characterized by A disorder characterized by or ; or 1 or or ; / or / Grade 3 / disabling CTCAE disabling / Activities of Daily Living ADL self care ADL instrumental ADL Grade Grade jcog jcog 10002272 CTCAE Grade 3

5 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 2010 9 11 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

6 jcog 6 CTCAE - jcog CTCAE MedDRA/J 2010 9 11 CTCAE Steering Committee/ jcog jcog JMO MedDRA/J jcog jcog / jcog jcog jcog CTCAE - jcog CTCAE MedDRA/J - 2010 9 11 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.

7 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 : ; 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.

8 , , , , Blood and lymphatic system disorders Cardiac disorders1 / 57 jcog CTCAE - jcog CTCAE MedDRA/J - 2010 9 11 CTCAE CodeCTCAE CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 CTCAE AE TermDefinition 10061589 Aortic valvedisease ; ; ; ; : , 10003586 Asystole ; , -- ; 10003658 Atrial fibrillation , , , : ; P 10003662 Atrial flutter , , , : ; 200-300 / 10003673 Atrioventricularblock complete - , , : ; AV 10003674 Atrioventricularblock first degree , ---AV 200 PR 10007515 Cardiac arrest.

9 10008481 Chest pain -cardiac ; ; -- 10010276 Conductiondisorder ; ; ; 10010783 Constrictivepericarditis -- , 10019279 Heart failure , : BNP ; ; : 10069501 Left ventricularsystolicdysfunction -- ; 10061532 Mitral valvedisease ; ; ; ; : , 10027786 Mobitz (type) IIatrioventricularblock 2 , ; , , : ; PR AV 2 / 57