Alice Chen, MD, FACP Investigational Drug Branch, CTEP, DCTD National Cancer Institute CTCAE Version...
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Transcript of Alice Chen, MD, FACP Investigational Drug Branch, CTEP, DCTD National Cancer Institute CTCAE Version...
Alice Chen, MD, FACP Investigational Drug Branch, CTEP, DCTDNational Cancer Institute
CTCAE Version 4
CTCAE v3.0 Issues & MedDRA
CTCAE v3.0 Terms– Multiple concepts– One/many element of Grade description is
critical AE concept– Not all MedDRA terms
• 72% CTCAE = mapped to a single MedDRA term/code
• 28% CTCAE = CTEP-only code (with meaning to no one outside CTEP)
CTCAE Revision Status
Phase 1: – Represent terms as single concept – MedDRA terms– Address CTCAE v3.0 Terms only
Phase 2: • Address Grading (severity) scales• Add new terms (Working with MedDRA)
– CTEP Help Desk Requests; Others– Definitions for terms– caBIG VCDE conformity
Public Review: Phase 3:
– Working Group; Steering Committee; Advisory Board Review
Final: May 27 - Publication
General Characteristics of Grading Scale
• Grade 0 No AE or within normal limits. • Grade 1 Mild AE (minor; no specific medical
intervention; asymptomatic laboratory findings only, radiographic findings only; marginal clinical relevance)
• Grade 2 Moderate AE (minimal intervention; local
intervention; noninvasive intervention [packing, cautery] indicated); AE limiting instrumental ADL (e.g., shopping, laundry, transportation, ability to conduct finances).
General Characteristics of Grading Scale
• Severe AE (medically significant but not life-threatening). AEs• in which initial inpatient hospitalization or prolongation of existing
hospitalization is indicated; • that are important medical events that may not be immediately life-
threatening; • that do not result in death. • that do not result in hospitalization but may jeopardize the patient or may
require intervention either to prevent hospitalization or to prevent the AE from becoming life-threatening or potentially resulting in death.
• that are disabling (result in persistent or significant disability or incapacity). • Limit performance of basic activities of self care (getting in and out of
bed, dressing, eating, getting around inside, bathing, or using the toilet).
Grade 3
General Characteristics of Grading Scale
Grade 4 Life-threatening AE (the patient is at risk of death at the time of the event if immediate intervention is not undertaken)
Grade 5 Fatal Adverse Event
AE Terms: Draft 1
• Single concept MedDRA terms that are common in oncology practice
• ~66% of CTCAE v3.0 terms appear in Draft 1 exactly as mapped to MedDRA
• ~33% of CTCAE v3.0 terms have been deleted– Infection with/without/with unknown ANC + site-
specific infections• ~70 New terms• Remainder = Edits
INFECTION CATEGORY
• Infection with unknown ANC – Conjunctiva– MedDRA: Conjunctivitis infective -10010742
• Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) – Conjunctiva
• Infection with normal ANC or Grade 1 or 2 neutrophils - Conjunctiva
CTEP - only
codes
Comparison CTCAE v3.0 to Draft 1
CTCAE v3.0 Draft 1
Broad Grouping of Terms CATEGORY SOC
AE Terms Multiple concepts; non-MedDRA
Single concept MedDRA
Number of Terms 1,059 ~800
Grading Scale 0 – 5 0 - 5
Other Components
Short Name Yes No
Also Consider Yes TBD
Navigation Note Yes TBD
Representation as a Formal Vocabulary
No Yes
Definitions No Yes
Formal Ongoing Governance
No Yes
Summary CTCAE v4.0
• All AEs are MedDRA LLT terms that are common in oncology practice
• AE Terms will be organized by Primary SOC• Grading scales • CTCAE v4.0 DRAFT posted for public review /
comment March 23 – April 10, 2009• Listed on the CTEP website• CTCAE v4.0 publication May 27, 2009• Long term Governance being established