Common Terminology Criteria for Adverse Events (CTCAE)

1 Common Terminology Criteria for Adverse Events (CTCAE) version Published: May 28, 2009 ( : Sept. 15, 2009) JCOG CTCAE - JCOG CTCAE - 2010 2 1 1 CTCAE - JCOG CTCAE 2010 2 1 Common Terminology Criteria for Adverse Events (CTCAE) Publish Date: May 28, 2009 ( : Sept. 15, 2009) JCOG CTCAE - JCOG CTCAE - 2010 2 1 Quick Reference NCI AE AE Grade Components and Organization SOC MedDRA SOC.

2 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.

3 - Grade AE Grade AE Grade 5 Grade 5 AE Grade 5 2 CTCAE - JCOG CTCAE 2010 2 1 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 2010 2 1 JCOG CTCAE - JCOG JCOG CTCAE - JCOG 2009 5 National Cancer Institute NCI Cancer Therapy Evaluation Program CTEP Common Terminology Criteria for Adverse Events

4 (CTCAE) CTCAE JCOG CTEP CTCAE URL #ctc_40 20 -6 JCOG Japan Clinical Oncology Group/ / CTCAE Steering Committee JCOG PDF Excel JCOG JCOG Excel PDF Grade

5 CTCAE Term MedDRA 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 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 4 CTCAE - JCOG CTCAE 2010 2 1 what

6 Was actually done what should be done 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 CTCAE

7 LLN ULN ANC AGC pRBC TPN IVR CNS CTCAE - JCOG CTCAE MedDRA MedDRA/J 2009 12 28 CTCAE 2010 2 1 CTCAE CTCAE JCOG 5 CTCAE - JCOG CTCAE 2010 2 1 CTCAE Steering Committee/ JCOG JCOG JMO MedDRA/J JCOG JCOG / JCOG JCOG JCOG CTCAE - JCOG CTCAE - 2010 2 1 CTCAE CodeCTCAE CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Grade

8 5 CTCAE AE TermDefinition 10002272 Anemia LLN g/dL; LLN mmol/L; LLN 100 g/L g/dL; ; 100 80g/L g/dL; ; 80 65g/L ; 100mL 10048580 Bone marrowhypocellular 25 25 50 50 75 2 10013442 Disseminatedintravascularcoagulation - ; 10016288 Febrileneutropenia -- ; 10019491 Hemolysis : ; DAT;Coomb's; ; , 2g/dl , : ; 10019515 Hemolytic uremicsyndrome - : , : , / , 10024378 Leukocytosis -- 100,000/mm3.

9 10025182 Lymph node pain ; ; -- 10041633 Spleen disorder : ; - ; 10043648 Thromboticthrombocytopenicpurpura - : , : , / , 10005329 Blood andlymphatic systemdisorders - Other,specify , ; ; ; / / ; , ; ; / ; ; 10051592 Acute coronarysyndrome - , ; ; , , , , 10061589 Aortic valvedisease.

10 : , Blood and lymphatic system disorders Cardiac disorders1 / 58 JCOG CTCAE - JCOG CTCAE - 2010 2 1 CTCAE CodeCTCAE CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 CTCAE AE TermDefinition 10003586 Asystole