MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
3. MedDRA Definition
MedDRA is a clinically-validated
international medical terminology used by
regulatory authorities and the regulated
biopharmaceutical industry. The terminology
is used through the entire regulatory process,
from pre-marketing to post-marketing and for
data entry, retrieval, evaluation and
presentation
3
4. Scope
OUT
Drug product terms
IN
Diseases Population-level qualifiers
Diagnoses
Signs
Symptoms
Patient demographic Therapeutic indications Numerical values for
terms Investigation names & qualitative results
results
Medical & surgical procedures
Medical, social, family history
Terms from:
COSTART
Device failure terms WHO-ART Severity descriptors
HARTS
Equipment, device,
diagnostic product terms
Clinical trial study design terms
5. MedDRA Structure and Growth
Version 2.1 Version 7.0 Version 8.0
26 26 26 System Organ Class
334 332 332 High-Level Group Term
1,663 1,681 1,683 High-Level Term
11,193 16,449 16,751 Preferred Term
35,065 44,755 45,597 Lowest-Level Term
5
6. MedDRA Structure and Growth
Version 8.0 Version 8.1
26 26 System Organ Class
332 332 High-Level Group Term
1,683 1,683 High-Level Term
16,751 16,976 Preferred Term
45,597 45,974 Lowest-Level Term
6
7. System Organ Class
Highest level of the hierarchy
SOCs identified by
Anatomical or physiological system
Etiology
Purpose
7
8. System Organ Class
Blood and lymphatic system Musculoskeletal and connective
disorders tissue disorders
Cardiac disorders Neoplasms benign, malignant and
Congenital, familial and genetic unspecified (incl cysts and polyps)
disorders Nervous system disorders
Ear and labyrinth disorders Pregnancy, puerperium and
Endocrine disorders perinatal conditions
Eye disorders Psychiatric disorders
Gastrointestinal disorders Renal and urinary disorders
General disorders and Reproductive system and breast
administration site conditions disorders
Hepatobiliary disorders Respiratory, thoracic and
Infections and infestations mediastinal disorders
Immune system disorders Skin and subcutaneous tissue
disorders
Injury, poisoning and procedural Social circumstances
complications
Investigations Surgical and medical procedures
Metabolism and nutrition disorders Vascular disorders
8
9. High Level Group Term
Subordinate only to System Organ
Classes and superordinate descriptor for
one or more HLTs
SOC
Gastrointestinal disorders
HLGT HLGT HLGT
Dental and Gastrointestinal Gastrointest
gingival infections inal vascular
conditions conditions
10. High Level Term
Subordinate to HLGTs and superordinate
descriptors for the PTs linked to it
SOC
Gastrointestinal
disorders
HLGT
Gastrointestinal infections
HLT
HLT
Gastrointestinal HLT
Intestinal
infections, site Peritoneal infections
infections
unspecified
11. Preferred Term
Each Preferred Term represents a single
medical concept:
• SOC Gastrointestinal disorders – HLGT Gastrointestinal
infections – HLT - Gastrointestinal infections, site unspecified
- PTs Abdominal sepsis, Amoebic dysentery, Tuberculosis
gastrointestinal, Gastrointestinal anthrax . . .
11
12. Preferred Term
PT Characteristics
• No limit to the amount of LLTs that can be
associated with a single PT
• An identical LLT is created for every PT
• Each path to a SOC from a PT should have exactly
one HLT and HLGT (one route)
PT → HLT → HLGT → SOC
• PTs can be represented in multiple SOCs
(multiaxality)
12
13. Lowest Level Term
LLT Characteristics: Developed to
support consistent coding
• An LLT has one or more of the following
relationships to a PT:
– Synonym
– Lexical variant
– Quasi-synonym (colloquial terms)
• Many terms from included terminologies
are represented at the LLT level
13
14. Lowest Level Term
LLT Characteristics cont.
• Constitutes the entry level of the
terminology and is linked to a single PT
• Can have current or non-current status
• Culturally unique terms are found at this
level
14
15. NEC = Not Elsewhere Classified
For specific, yet miscellaneous, terms that do not readily fit into
hierarchical classifications, used only at the HLT and HLGT
levels
HLT
Congenital disorders NEC
PT
PT Hereditary
Congenital PT PT PT
angioedema
abnormality Conjoined Hereditary Umbilical
twins disorders malformation
16. MedDRA Codes
Each MedDRA term assigned an 8-digit numeric code
The code is non-expressive
Codes can fulfill a data field in various electronic
submission types (e.g., E2b)
Initially assigned alphabetically by term starting with
10000001
New terms are assigned sequentially
Codes are never reused
Supplemental terms are assigned codes
16
17. Anatomy (Body System)
Blood and lymphatic system disorders
Cardiac disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
Hepatobiliary disorders
Immune system disorders
Musculoskeletal and connective tissue disorders
Nervous system disorders
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Vascular disorders
17
18. Other (Cause/Association)
Congenital, familial and genetic disorders
General disorders and administration site conditions
Infections and infestations
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pregnancy, puerperium and perinatal conditions
Social circumstances
Surgical and medical procedures
18
19. General disorders and administration site
conditions
SOC specific topics:
SOC includes terms that are very general in nature
e.g.. Pain, Mass, Tenderness etc.
Administration site conditions all grouped here
(also in Injury SOC).
• Application
• Injection
• Implant
Much of this SOC is not multi-axial
19
20. Congenital, familial and genetic
disorders
SOC specific topics:
Primary SOC for all congenital conditions
Primary SOC for all congenital conditions
Congenital = any condition present at birth,
whether genetically inherited or acquired in utero
definition used for placement into this SOC
HLGTs categorized either by an anatomical basis
following the naming conventions of the SOCs
Look here for the congenital condition, look in the
anatomy SOC for grouping with non-congenital
conditions
20
21. Injury, poisoning and procedural
complications
SOC specific topics:
Can be considered the “due to SOC”
HLGTs are representing either the agent
that caused the injury or anatomy
Only SOC where cardiac and vascular are
considered together (cardiovascular
injuries)
Overdose, poisoning, misadministrations
etc are located here
21
22. Investigations
SOC specific topics:
Single axial SOC
Represents only the results of tests (no
interpretation)
HLGTs represent various large groupings of tests
PTs naming convention is: Test identifier,
specimen type, qualifier
• Qualifiers include: normal, increased,
decreased, abnormal NOS (no direction of
abnormality specified)
– There will always be an investigation term
without any qualifier to be used when no value
is given (e.g., PT: Hematocrit)
22
23. Infections and infestations
SOC specific topics:
All infections are primary to the Infection SOC
HLGTs categorized either infectious agent or on an
anatomical basis under pathogen class unknown.
HLGT refers to taxonomy of pathogen e.g..
Bacterial, Fungal etc.
HLT references the genus
PT refers to genus plus anatomy
LLT references the species
23
24. Metabolism and nutrition disorders
SOC specific topics:
HLGTs represent metabolic disorders
divided by substance being metabolized or
nutritional disorders
This SOC is based upon substance, cause
would be represented in anatomical or
congenital SOCs
24
25. Neoplasms benign, malignant and
unspecified (incl cysts and polyps)
SOC specific topics:
Primary SOC for all Neoplasms
Secondary SOC for all Cysts and Polyps
Developed with the help of National Cancer
Institute (CTEP)
Applies international naming conventions
HLGTs classify anatomy
HLTs distinguish staging
Includes very specific as well as very general
terms
25
26. Pregnancy, puerperium and perinatal
conditions
SOC specific topics:
Contains terms for classifying disorders as well as
normal conditions
Age is important in using this SOC e.g.. Neonatal
Topics of mother and child are covered within this
SOC
The HLGT Abortion and stillbirth includes
spontaneous and abnormal conditions, procedures
and complications
26
27. Social circumstances
SOC specific topics:
Contains terms for categorizing life style factors
Does not contain disorders
Single axial
Drug and chemical abuse does not include alcohol
Coding with this SOC requires full understanding
of the SOC and its interpretation
27
28. Surgical and Medical Procedures
SOC specific topics:
HLGTs are broken down by anatomy or procedural
type
Only section of the terminology where Ear, nose
and throat are grouped.
Single axial
Represents only procedures, complications are
represented in the Injury, poisoning and
procedural complications SOC, the reason for the
procedure is represented in the disorders SOC
28
29. In what SOC would you find the
following:
Hypoglycemia
Decreased heart rate
Drug addict
Bacterial infection
Pneumonitis
Broken leg
Injection site pain
29
30. Using MedDRA’s Hierarchy
Important functions of a hierarchy are as follows:
Provides a grouping scheme for data analysis
Defines the meaning of word and its relationship to terms
associated with it
Defines/limits the meaning of lateral terms
Serves as a pre-developed method of grouping data for
analysis
Supports consistent data representation
Supports standardized data reporting.
MedDRA is NOT a taxonomy.
Be careful to understand the interaction of the hierarchy and
multiaxiality.
30
31. A Multi-Axial Terminology
Multi-axial = the representation of a
medical concept in multiple SOCs
Allows terms to be grouped by different
classifications
Allows retrieval and presentation via different data
sets
Allows an automatic assignment of pre-defined term
groupings
31
32. Primary SOC Allocation
Every PT is assigned to a Primary SOC
Purpose of Primary SOC
– Determines which SOC will represent a PT
during cumulative data outputs
– Is used to support consistent data
presentation for reporting
– Secondary SOCs are used for additional
scientific analysis
32
33. Rules for
Primary SOC Allocation
PTs relating to diseases or signs and symptoms
are assigned to the SOC that best represents
the primary manifestation site
PT: Appendicitis = Primary SOC:
Gastrointestinal disorders
PT: Dry Skin = Primary SOC:
Skin & subcutaneous tissue disorders
PT: Nausea = Primary SOC:
Gastrointestinal disorders
33
34. Exceptions for
Primary SOC Allocation
All congenital and hereditary anomalies
are placed in the Congenital, familial
and genetic disorders SOC as their
Primary SOC
34
35. Exceptions for
Primary SOC Allocation
Primary SOC Congenital and familial/genetic
disorders
Example PT
Congenital rubella infection
Secondary SOC
Pregnancy, puerperium and perinatal conditions
Infections and infestations
35
36. Exceptions for
Primary SOC Allocation
All neoplasms are placed in the
Neoplasms benign and malignant
(including cysts and polyps) SOC as their
Primary SOC
36
37. Exceptions for
Primary SOC Allocation
Primary SOC Neoplasms benign,malignant and
unspecified (including cysts and polyps)
Example PT
Benign lung neoplasm
Secondary SOC
Respiratory, thoracic
and mediastinal disorders
37
38. Exceptions for
Primary SOC Allocation
Exception:
Cysts and polyps are placed in the
prime manifestation site as their
Primary SOC
38
39. Exceptions for
Primary SOC Allocation
Primary SOC Ear and labyrinth disorders
Example PT Secondary SOC
Aural polyp Neoplasms benign,
malignant and
unspecified
(including cysts and
polyps)
39
40. Exceptions for
Primary SOC Allocation
All infections and infestations are placed
in the Infections and infestations SOC
as their Primary SOC
40
41. Exceptions for
Primary SOC Allocation
Primary SOC Infections and infestations
Example PTs Secondary SOC
Hepatitis C Hepato-biliary disorders
Nervous system disorders
Encephalitis
Respiratory, thoracic and
Pneumonia mediastinal disorders
41
42. A Multiaxial Terminology
PTs in the following SOCs only appear
in that particular SOC:
Investigations
Social circumstances
Surgical and medical procedures.
42
45. Using MedDRA to Your Benefit
Multiaxiality
SOC= Infection and SOC = Hepatobiliary
infestations disorders
HLGT = Viral HLGT = Hepatic
disease disorders
HLT = Hepatic
viral infection
PT = Hepatitis C
45
46. Using MedDRA to Your Benefit
Multiaxiality (Continued)
SOC = Hepatobiliary
disorders
HLGT = Hepatic
disorders
HLT = Hepatic HLT = Hepatic signs
viral infection and symptoms
PT = Hepatitis C PT = Hepatomegaly
46
47. Using MedDRA to Your Benefit
Multiaxiality (Continued)
Impact of multiaxiality on analysis:
PTs are represented in more than one
SOC.
Secondary path is used in SOC analysis.
Use of multiaxiality.
Double counting is prevented.
Multiple data representation is supported.
Related terms in different SOCs are
revealed. 47
48. In what SOC would the following
terms be primary:
Community acquired pneumonia
Congenital HIV infection
Kaposi’s Sarcoma
HIV wasting syndrome
Wasting
Intestinal polyp
Endometrial sarcoma
48
49. Special Search Category
Standardizes frequently used searches
Helps define the syndromes/diseases
Facilitates analysis across SOCs
Groups PTs at the PT level
(horizontally)
Will be retired with MedDRA version 10
49
51. Standardized MedDRA Query
Standardizes frequently used searches
Helps define the syndromes/diseases
Facilitates analysis across SOCs
Allows for broad and narrow searches
(sensitivity vs. specificity)
Is tested by MedDRA subscribers
Is maintained by the MedDRA MSSO
51
52. Acknowledgement
MedDRA® is a registered trademark of the International
Federation of Pharmaceutical Manufacturers & Associations
(IFPMA)
52