CTCAE v3.0 JCOG/JSCO v1.0 Instructions and Guidelines for Japanese CTCAE v3.0 by JCOG and JSCO JCOG JCOG JCOG JCOG 2004 5 13 2004 7 1 2004 10 1 2004 10 27 JCOG http://www.jcog.jpjcog
0. 0.1. NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 JCOG NCINational Cancer Institute CTCAE v3.0 CTCAE v3.0 Online Instructions and Guidelines 100 CTCAE v3.0 / 0.2. CTCAE v3.0 CTCAE v3.0 CTCAE v3.0 Grade 0.3. /report CRF(Case Report Form) report report/ 1
0.... 1 0.1.... 1 0.2. CTCAE v3.0... 1 0.3. /report... 1 1. CTCAE... 4 1.1. CATEGORY... 4 1.1.1. Navigation Note... 4 1.1.2. Other (Specify)... 4 1.2. Adverse Events... 4 1.2.1. Supra-Ordinate Terms... 4 1.2.2. Select AE... 5 1.2.3. Short Name... 5 1.2.4. Remark... 5 1.2.5. AE Also Consider... 5 1.3. Grade...6 1.3.1. Em Dash... 6 1.3.2. /... 6 1.3.3. Grade Alternate Grading Criteria... 7 1.4. Attribution... 7 2. Grade... 9 2.1. Activity of Daily Livings (ADLs)... 9 2.2. Hospitalization and Prolongation of Hospitalization... 9 2.3.... 9 2.4.... 9 2.5. Intervention... 9 2.6. vs. Indicated vs. Required... 10 2
3. CTCAEv3.0 JCOG/JSCO Using the CTCAE... 10 3.1. Introduction... 10 3.1.1. nearest match... 10 3.2....11 3.2.1. / Reporting Late Effects and Chronicity... 11 3.2.2. Start and Stop Dates... 11 3.2.3. AE Recurrence... 11 3.3.... 12 3.3.1. Multimodality Therapies... 12 3.3.2. Intervention... 12 3.3.3. / Reporting Pediatric AEs... 12 3.4. Grading... 12 3.4.1. Grading Grade Assignment Responsibility... 12 3.4.2. Grade5Death... 12 3.4.3. Disease Progression... 13 3.4.4. Baseline... 13 3.4.5. CTCAE v3.0 AEs not listed in the CTCAE v3.0... 13 3.4.6. Grade Consistency... 13 3.4.7. Dose-Limiting Adverse Event... 13 3.4.8. Acceptable vs Unacceptable AEs... 14 3.4.9. Grade What not to Grade... 14 3.4.10. Grading Information Sources for Grading AEs... 14 4. CTCv2.0 CTCAE v3.0... 15 4.1.... 15 4.1.1. DEATH... 15 4.1.2. GROWTH AND DEVELOPMENT... 15 4.1.3. / SURGERY/INTRA-OPERATIVE INJURY... 15 4.1.4. VASCULAR... 15 4.2. Deleted Components... 15 4.2.1. Modality-Specific AE Descriptions... 15 4.2.2. Population-Specific AE Descriptions... 16 4.2.3. Grade... 17 5. JCOG/JSCO... 18 5.1.... 18 3
1. CTCAE CTCAE v3.0 Grade 3 3 1.1. CATEGORY // 1.1.1. Navigation Note / CTCAE v3.0 * CARDIAC GENERAL * JCOG (http://www.jcog.jp) 1.1.2. Other (Specify) CTCAE v3.0 Grading CTCAE v3.0 / / / DERMATOLOGY/SKIN DEATH 1.2. Adverse Events 1.2.1. Supra-Ordinate Terms 4
Grading / - - 1.2.2. Select AE Grade Medical Dictionary for Regulatory Activities: MedDRA 1.2.3. Short Name Short NameCase Report Form: CRF 1.2.4. Remark 1.2.5. AE Also Consider grading AE Grading / 5
1.3. Grade Grade 05 6 Grade 0 CTCAE v3.0 Grade 0 Grade 0 Grade 5 Grade5 Grade Grade 0 Grade 1 / Grade 2 // Grade 3 /IVR/// Grade 4 / / IVR// Grade 5 1.3.1. Em Dash Grade 1.3.2. / Grade / () Grade2 ; (: ); 24 6
(: ) 24 1.3.3. Grade Alternate Grading Criteria Grade 1 Grade //Mucositis/stomatitis(functional/symptomatic) / Grade 2 Grade 3 Grade 1.4. Attribution (Attribution) 7
Grade4 1 / / 2 3 5 definite 4 probable 3 possible 2 unlikely 1 not related (unrelated) 8
2. Grade 2.1. Activity of Daily Livings (ADLs) 2.2. Hospitalization and Prolongation of Hospitalization (overnight stay)* *overnight stayso-called 23 hour observation 2.3. NCI-CTCv2.0 1 1 1 2,3 1 2.4. Grade3 prbc 4.5 ( 10 cc/kg) prbc 4.5 10cc/kg grading 2.5. Intervention CTCAE v3.0 intervention Medical intervention Operative intervention Intervention; Therapeutic intervention Invasive intervention Interventional radiology interventionivr 9
Endoscopic intervention Localized, local intervention Antiviral intervention 2.6. vs. Indicated vs. Required CTCAE v3.0 grade indicatedrequired indicated=required= / indicated= what was actually done what should be done grading 3. CTCAEv3.0 JCOG/JSCO Using the CTCAE 3.1. Introduction CTCAE v3.0 / 2 1 / / 2 / / 1.4. Attribution 3.1.1. nearest match NCI-CTC JCOG 2 CTC NCI Common Toxicity Criteria Manualnearest match grade3 grade3 NCI-CTC JCOG 2 CTCAEv3.0 grade grade nearest matchindicated vs. required 10
3.2. 3.2.1. / Reporting Late Effects and Chronicity CTCAE v3.0 v2.0 90 RTOG/EORTC CTCAE v3.0 CTCAE v3.0 duration 1 1 1 Grading grade grade /CTCAE v3.0 grade / / / 21 1 20 // / interval 2 35 610 1130 30 3190 91360 3.2.2. Start and Stop Dates [Adverse Event Expedited Reporting SystemAdEERS]* Day 5 =grade 4; Day10 = grade 3; *AdEERS FDA(Food and Drug Administration) 3.2.3. AE Recurrence 1 / 2 grade / 11
3.3. 3.3.1. Multimodality Therapies CTCAEv3.0 grade grading CTCAE v3.0 grading 3.3.2. Intervention / / / 3.3.3. / Reporting Pediatric AEs grade 3.4. Grading 3.4.1. Grading Grade Assignment Responsibility grading / CTCAE 3.4.2. Grade5Death CTCAE v3.0 / 1. CTCAE grade5 2. CTCAE - grade5 3. CTCAE -grade 5 1.CTC v2.0 grade3/4 grade5 CTCAE v3.0 1 grade5 2. DEATH1. grade5 3.-grade5 NCI CTCv2.0 12
grade3/4 grade5 CTCAEv3.0 1 grade5 1 1 Grade5 3.4.3. Disease Progression CTCAE v3.0 progressive diseaserecist WHO -- grading RECIST WHO - - grading 3.4.4. Baseline grade CTCAE v3.0 grading grade 1 1 3.4.5. CTCAE v3.0 AEs not listed in the CTCAE v3.0 CTCAE v3.0 grade15 grading 3.4.6. Grade Consistency Grade grade grade3 grade3 3.4.7. Dose-Limiting Adverse Event Dose-Limiting Adverse Event: DLT: grade3 13
3.4.8. Acceptable vs Unacceptable AEs CTCAE grade1,2 grade3,4 I grade3, 3.4.9. Grade What not to Grade (Treatment delivery system malfunctions) grading 3.4.10. Grading Information Sources for Grading AEs Grading 1 Patient Diary Reports of Adverse Event 2 History and Physical Exam CTCAEv3.0 AE 3 Clinical Emergency grading grading 14
4. CTCv2.0 CTCAE v3.0 4.1. 4.1.1. DEATH grade5 / grade5 grade5 / grade5 CTCAE - Death NOS; - Disease progression NOS; Multi-organ failure; Sudden death 4.1.2. GROWTH AND DEVELOPMENT () 4.1.3. / SURGERY/INTRA-OPERATIVE INJURY / 4.1.4. VASCULAR CTC v2.0 CTCAE v3.0 4.2. Deleted Components 4.2.1. Modality-Specific AE Descriptions CTCAE v.3.0 RTOG/EORTC 90 / 15
1) : / DERMATOLOGY/SKIN 2) 3 /(/) 4.2.2. Population-Specific AE Descriptions CTC v2.0 CTCAE v3.0 1 (BMT) CTCAE v3.0 Veno-Occlusive Disease:VOD (Hepatic enlargement) 16
4.2.3. Grade CTC v2.0 CTCAE v3.0 grading 1 Grading / BLOOD/BONE MARROW Grade 3 4 CTC v2.0: Platelets CTCAE v3.0: Platelets 10.050.0 x 10 9 /L 1000050000/mm 3 50,00025,000 /mm 3 50.025.010 9 /L 10.0 x 10 9 /L 10000 /mm 3 25,000 /mm 3 25.010 9 /L 2 DIC CTC v2.0 grade3grade4 CTCAE v3.0 grade2grade3 grade4 COAGULATION Grade 1 2 3 4 CTC v2.0: DIC( CTCAE v3.0: DIC /: 3 QTc CTCAE v3.0 grading CARDIAC ARRHYTHMIA Grade 1 2 3 4 CTC v.2.0: QTc (CHF 0.48 Prolonged QTc ) interval CTCAE v3.0: QTc QTc QTc 0.470.50 QTc0.50 QTc0.50 ; Prolonged QTc interval 0.450.47 ; : 0.06 ;Torsade de pointe 17
5. JCOG/JSCO CTCAEv3.0 grade grading CTCAEv3.0 JCOG NCI CTCAE 5.1. / / Grade34 Grade 1 2 grade 4 JCOG 18