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1 CTCAE v3.0 JCOG/JSCO v1.0 Instructions and Guidelines for Japanese CTCAE v3.0 by JCOG and JSCO JCOG JCOG JCOG JCOG JCOG
2 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
3 CTCAE v /report CTCAE CATEGORY Navigation Note Other (Specify) Adverse Events Supra-Ordinate Terms Select AE Short Name Remark AE Also Consider Grade Em Dash / Grade Alternate Grading Criteria Attribution Grade Activity of Daily Livings (ADLs) Hospitalization and Prolongation of Hospitalization Intervention vs. Indicated vs. Required
4 3. CTCAEv3.0 JCOG/JSCO Using the CTCAE Introduction nearest match / Reporting Late Effects and Chronicity Start and Stop Dates AE Recurrence Multimodality Therapies Intervention / Reporting Pediatric AEs Grading Grading Grade Assignment Responsibility Grade5Death Disease Progression Baseline CTCAE v3.0 AEs not listed in the CTCAE v Grade Consistency Dose-Limiting Adverse Event Acceptable vs Unacceptable AEs Grade What not to Grade Grading Information Sources for Grading AEs CTCv2.0 CTCAE v DEATH GROWTH AND DEVELOPMENT / SURGERY/INTRA-OPERATIVE INJURY VASCULAR Deleted Components Modality-Specific AE Descriptions Population-Specific AE Descriptions Grade JCOG/JSCO
5 1. CTCAE CTCAE v3.0 Grade CATEGORY // Navigation Note / CTCAE v3.0 * CARDIAC GENERAL * JCOG ( Other (Specify) CTCAE v3.0 Grading CTCAE v3.0 / / / DERMATOLOGY/SKIN DEATH 1.2. Adverse Events Supra-Ordinate Terms 4
6 Grading / Select AE Grade Medical Dictionary for Regulatory Activities: MedDRA Short Name Short NameCase Report Form: CRF Remark AE Also Consider grading AE Grading / 5
7 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 Em Dash Grade / Grade / () Grade2 ; (: ); 24 6
8 (: ) Grade Alternate Grading Criteria Grade 1 Grade //Mucositis/stomatitis(functional/symptomatic) / Grade 2 Grade 3 Grade 1.4. Attribution (Attribution) 7
9 Grade4 1 / / definite 4 probable 3 possible 2 unlikely 1 not related (unrelated) 8
10 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-CTCv , Grade3 prbc 4.5 ( 10 cc/kg) prbc cc/kg grading 2.5. Intervention CTCAE v3.0 intervention Medical intervention Operative intervention Intervention; Therapeutic intervention Invasive intervention Interventional radiology interventionivr 9
11 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 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
12 / Reporting Late Effects and Chronicity CTCAE v3.0 v RTOG/EORTC CTCAE v3.0 CTCAE v3.0 duration Grading grade grade /CTCAE v3.0 grade / / / // / interval Start and Stop Dates [Adverse Event Expedited Reporting SystemAdEERS]* Day 5 =grade 4; Day10 = grade 3; *AdEERS FDA(Food and Drug Administration) AE Recurrence 1 / 2 grade / 11
13 Multimodality Therapies CTCAEv3.0 grade grading CTCAE v3.0 grading Intervention / / / / Reporting Pediatric AEs grade 3.4. Grading Grading Grade Assignment Responsibility grading / CTCAE 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
14 grade3/4 grade5 CTCAEv3.0 1 grade5 1 1 Grade Disease Progression CTCAE v3.0 progressive diseaserecist WHO -- grading RECIST WHO - - grading Baseline grade CTCAE v3.0 grading grade CTCAE v3.0 AEs not listed in the CTCAE v3.0 CTCAE v3.0 grade15 grading Grade Consistency Grade grade grade3 grade Dose-Limiting Adverse Event Dose-Limiting Adverse Event: DLT: grade3 13
15 Acceptable vs Unacceptable AEs CTCAE grade1,2 grade3,4 I grade3, Grade What not to Grade (Treatment delivery system malfunctions) grading 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
16 4. CTCv2.0 CTCAE v DEATH grade5 / grade5 grade5 / grade5 CTCAE - Death NOS; - Disease progression NOS; Multi-organ failure; Sudden death GROWTH AND DEVELOPMENT () / SURGERY/INTRA-OPERATIVE INJURY / VASCULAR CTC v2.0 CTCAE v Deleted Components Modality-Specific AE Descriptions CTCAE v.3.0 RTOG/EORTC 90 / 15
17 1) : / DERMATOLOGY/SKIN 2) 3 /(/) Population-Specific AE Descriptions CTC v2.0 CTCAE v3.0 1 (BMT) CTCAE v3.0 Veno-Occlusive Disease:VOD (Hepatic enlargement) 16
18 Grade CTC v2.0 CTCAE v3.0 grading 1 Grading / BLOOD/BONE MARROW Grade 3 4 CTC v2.0: Platelets CTCAE v3.0: Platelets x 10 9 /L /mm 3 50,00025,000 /mm /L 10.0 x 10 9 /L /mm 3 25,000 /mm /L 2 DIC CTC v2.0 grade3grade4 CTCAE v3.0 grade2grade3 grade4 COAGULATION Grade CTC v2.0: DIC( CTCAE v3.0: DIC /: 3 QTc CTCAE v3.0 grading CARDIAC ARRHYTHMIA Grade CTC v.2.0: QTc (CHF 0.48 Prolonged QTc ) interval CTCAE v3.0: QTc QTc QTc QTc0.50 QTc0.50 ; Prolonged QTc interval ; : 0.06 ;Torsade de pointe 17
19 5. JCOG/JSCO CTCAEv3.0 grade grading CTCAEv3.0 JCOG NCI CTCAE 5.1. / / Grade34 Grade 1 2 grade 4 JCOG 18
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19 CSPOR CRC/2009.8.8-9 2009 8 8 ( ) - CSPOR CRC SEMINAR- twatanab@oncoloplan.com http://www.oncoloplan.com - Toru Watanabe MD - 2 Phase I: Dose Finding trial Phase II : Efficacy and Safety trial Phase
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