CTCAE v4.0 Objectives

CTCAE v4.0
Common Terminology Criteria for Adverse Events
Presented by:
Vicki Duvall and Michele Copersino
May 28, 2010
Objectives
• Summarize use of CTCAE
• Describe rationale for CTCAE v3.0 revision
• Define MedDRA
• Identify status quo and minor changes CTCAE v3.0 to
CTCAE v4.0
• Review resources available for CTCAE v4.0 materials
2
CTCAE Definition, Rationale, Evolution
• List of Adverse Event (AE) terms commonly encountered
in oncology
• Each AE is accompanied by a grading (severity) scale
• CTCAE is the agreed upon terminology for the
designation, reporting and grading of AEs
• Evolution
• 1984 CTC v1.0
• 1998 CTC v2.0
• 2003 CTCAE v3.0
• 2009 CTCAE v4.0
49 AE terms
300 AE terms *
1059 AE terms*
790 AE Terms (MedDRA LLTs)
*Mapped to MedDRA (Medical Dictionary for Regulatory Activities) terminology
3
Impetus for 2009 Revision
•
2006 MedDRA Meeting
•
•
2007 NCI/CTEP, FDA discussions
•
•
AE Reporting: MedDRA vs. CTCAE
AE data analysis MedDRA vs. CTCAE
2008 Evaluation of CTCAE v3.0 as a standard terminology
•
Non-standardized AE terminology
•
Non-machine interpretable
•
No definitions
4
Relax!
v4.0 is fundamentally unchanged
5
CTCAE pdf
6
CTCAE v4.0 What’s the Same?
Components
v3.0
v4.0
7
Unchanged
CTCAE v4.0
Remains a list of AE terms
associated with a 5-point
Grading (severity) scale
8
CTCAE v4.0 What’s New?
Use of MedDRA
•
Introduction to MedDRA
•
Clinically validated international medical terminology used by
regulatory authorities and the biopharmaceutical industry
•
multiple languages
•
Hierarchical (terms arranged form highest to lowest level)
• System Organ Class (SOC) 26
CTCAE v4.0
• High Level Group Term (HLGT)
• High Level Term (HLT)
• Preferred Term (PT)
• Lowest Level Term (LLT) > 66,000
CTCAE v4.0 (small subset of total)
9
What’s New?
v3.0 Category is v4.0 SOC (System Organ Class)
CTCAE v3.0 CATEGORY
Count 28
CTCAE v4.0 SOC
Count 26
AUDITORY/EAR
Ear and labyrinth disorders
DERMATOLOGY/SKIN
Skin and subcutaneous tissue
disorders
ENDOCRINE
Endocrine disorders
INFECTION
Infections and infestations
PULMONARY/UPPER RESPIRATORY Respiratory and thoracic disorders
VASCULAR
Vascular disorders
What’s New?
v3.0 Category is v4.0 SOC (System Organ Class)
CTCAE v3.0 CATEGORY
CTCAE v4.0 SOC
CARDIAC ARRYTHMIA
Cardiac disorders
CARDIAC GENERAL
Nervous system disorders
NEUROLOGY
Psychiatric disorders
What’s New?
Some v3.0 Categories deleted in v4.0
CTCAE v3.0
CATEGORY
DEATH
CTCAE v4.0 SOC
General disorders and administration site conditions
(Death NOS; Death neonatal; Sudden death NOS)
Pregnancy, puerperium and perinatal conditions
(Fetal death)
GROWTH &
DEVELOPMENT
Musculoskeletal and connective tissue disorders
PAIN
System – specific SOC (Ear and labryinth disorders;
Gastrointestinal disorders; Renal and urinary disorders;
etc. )
HEMORRHAGE
SYNDROMES
Blood and lymphatic system disorders; Cardiac
disorders; Immune system disorders; Metabolism and
nutrition disorders; Neoplasms benign, malignant and
unspecified (incl cysts and polyps); etc.
What’s New?
Example of v4.0 use of MedDRA SOC
- SOC
General disorders and administration site conditions
- HLGT
General system disorders NEC
- HLT
Asthenic Conditions
- PT
Fatigue
- LLT
Fatigue (CTCAE v4 term)
Chronic fatigue
Exhaustion
Fatigue ability
Fatigue extreme
Tired all the time
Tiredness
Tired out
+ 13 more LLTs (related terms)
CTCAE v4.0 SOC replaces CATEGORY
v3.0
v4.0
14
What’s New?
v4.0 AE terms are MedDRA LLTs
v3.0
CTCAE v3.0 Multiple concepts were mapped to MedDRA: Fatigue 10016256
v4.0
CTCAE v4.0 AE terms are single concept MedDRA terms
15
What’s New?
v4.0 AE terms are MedDRA LLTs
CTCAE v3.0
CATEGORY
CTCAE v3.0 AE
Term
CTCAE
v4.0 SOC
CTCAE v4.0 AE
Term
PULMONARY/
UPPER RESPIRATORY
Voice changes/
dysarthria (e.g.,
hoarseness, loss or
alteration in voice,
laryngitis)
Respiratory,
thoracic and
mediastinal
disorders
Voice alteration
Hoarseness
Laryngeal inflammation
Nervous
system
disorders
Aphonia
Dysarthria
Infections
and
infestations
Laryngitis
What’s New?
v3.0 Infection + ANC combinations Deleted
What’s New?
Infection term - Select Deleted
What’s New?
Short Name Deleted
v3.0
v4.0
19
What’s New?
v3.0 Supra-ordinate term – Select Deleted
20
v4.0
v4.0
21
Summary
Comparison CTCAE v3.0 to v4.0
CTCAE v3.0
CTCAE v4.0
CATEGORY (28)
SOC (26)
Combination AE terms
Single concept MedDRA LLTs
Short Names
None
Supra-ordinate terms
None
1,059 AE terms (28 = Other, specify)
790 AE terms (26 = Other, specify)
Summary
CTCAE v4.0 AE Terms
•
Each AE term is
•
A MedDRA LLT
•
Listed within the LLT Primary SOC
•
Accompanied by a definition
•
Associated with ‘related terms’
CTCAE v4.0 Documentation
•
Publications
•
•
•
Limited number of handbooks
CTEP website
•
CTCAE v4.0 ‘pdf version’
•
CTCAE mapping v3.0 to v4.0
BiomedGT Wiki
•
CTCAE v4.0 ‘interactive version’
CTCAE on the CTEP website
25
Multiple formats of CTCAE
26
CTCAE v4.0 on BiomedGT Wiki
27
CTCAE Terms Organized by SOC
CTCAE SOCs
Example: Click on
Blood and lymphatic
system disorders
28
All AEs
within SOC
displayed
Example: Click on Febrile Neutropenia
29
Options regarding Febrile Neutropenia
30
Example: Click on Definition
31
Example: Click on Related Terms
32
Example: Click on Factbox
33
Click on FAQ to see if question or issues
issue has
beenbeen
has
previously
previously
addressed
addressed
34
For More Information
•
CTEP
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_v40
•
BiomedGT Wiki
http://biomegt.nci.nih.gov/wiki/index.php/CTCAE4
Special Thanks
•
Ann Setser, CBIIT, NCI