MedDRA Distribution File
Format Document
Version 27.1

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Acknowledgements

ACKNOWLEDGEMENTS
MedDRA® trademark is registered by ICH.
COSTART Thesaurus Fifth Edition, Copyright © 1995 US Food and Drug Administration(FDA). Hoechst Adverse Reaction Terminology System (HARTS), Copyright © 1992
Aventis Pharma. ICD-9-CM, International Classification of Diseases, Ninth Revision,
Clinical Modification, Copyright© 1998 Medicode, Inc. ICD-10, Source: World HealthOrganization. WHO Adverse Reaction Terminology (WHO-ART), Copyright © 1998
World Health Organization Collaborating Centre for International Drug Monitoring.
Japanese Adverse Reaction Terminology (J-ART) is a product of the Ministry of Health,Labour and Welfare (MHLW).

Disclaimer and Copyright NoticeThis document is protected by copyright and may, with the exception of the MedDRA
and ICH logos, be used reproduced, incorporated into other works, adapted, modified,translated or distributed under a public license provided that ICH's copyright in the
document is acknowledged at all times. In case of any adaption, modification ortranslation of the document, reasonable steps must be taken to clearly label, demarcate
or otherwise identify that changes were made to or based on the original document. Any
impression that the adaption, modification or translation of the original document isendorsed or sponsored by the ICH must be avoided.
The document is provided "as is" without warranty of any kind. In no event shall the ICH
or the authors of the original document be liable for any claim, damages or other liability
arising from the use of the document.
The above-mentioned permissions do not apply to content supplied by third parties.
Therefore, for documents where the copyright vests in a third party, permission forreproduction must be obtained from this copyright holder.

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Table of Contents

TABLE OF CONTENTS
1.

INTRODUCTION .................................................................................................... 1

2.

GENERAL FILE INFORMATION ........................................................................... 2

3.

MedDRA SCHEMA ................................................................................................ 44.

TABLE DEFINITION .............................................................................................. 95.

TABLE JOINS...................................................................................................... 12

6.

DATA MODEL ..................................................................................................... 13

7.

CONSECUTIVE FILE INFORMATION ................................................................ 14

8.

MedDRA CONSECUTIVE FILE DESCRIPTIONS ............................................... 15

9.

CONSECUTIVE FIELD DEFINITIONS ................................................................ 19

LIST OF FIGURES
Figure 6-1. MedDRA Data Model ............................................................................................... 13

LIST OF TABLES
Table 2-1. MedDRA Files ............................................................................................................. 2
Table 2-2. MedDRA History File: meddra_history_english.asc .................................................. 3
Table 2-3. MedDRA Release File: meddra_release.asc ............................................................. 3
Table 3-1. 1_low_level_term Derived from MedDRA file: llt.asc ................................................. 4
Table 3-2. 1_pref_term Derived from MedDRA file: pt.asc ......................................................... 4
Table 3-3. 1_hlt_pref_term Derived from MedDRA file: hlt.asc................................................... 5
Table 3-4. 1_hlt_pref_comp Derived from MedDRA file: hlt_pt.asc ............................................ 5
Table 3-5. 1_hlgt_pref_term Derived from MedDRA file: hlgt.asc............................................... 5
Table 3-6. 1_hlgt_hlt_comp Derived from MedDRA file: hlgt_hlt.asc ......................................... 6
Table 3-7. 1_soc_term Derived from MedDRA file: soc.asc ........................................................ 6
Table 3-8. 1_soc_hlgt_comp Derived from MedDRA file: soc_hlgt.asc ....................................... 6
Table 3-9. 1_md_hierarchy Derived from MedDRA file: mdhier.asc ........................................... 7
Table 3-10. 1_soc_intl_order Derived from MedDRA file: intl_ord.asc ....................................... 7
Table 3-11. 1_smq_list Derived from MedDRA file: smq_list.asc ............................................... 7
Table 3-12. 1_smq_Content Derived from MedDRA file: smq_content.asc................................ 8
Table 4-1. Field Definitions in MedDRA Files ............................................................................ 11
Table 5-1. Joins between each of the files ................................................................................. 12
Table 7-1. MedDRA Consecutive Files ..................................................................................... 14
Table 8-1. MedDRA Consecutive File: llt.seq .......................................................................... 15
Table 8-2. MedDRA Consecutive File: pt.seq .......................................................................... 16
Table 8-3. MedDRA Consecutive File: hlt.seq ......................................................................... 16
Table 8-4. MedDRA Consecutive File: hlt_pt.seq .................................................................... 16
Table 8-5. MedDRA Consecutive File: hlgt.seq ....................................................................... 17
Table 8-6. MedDRA Consecutive File: hlgt_hlt.seq ................................................................. 17
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Table of Contents
Table 8-7. MedDRA Consecutive File: soc.seq ........................................................................ 17
Table 8-8. MedDRA Consecutive File: soc_hlgt.seq ................................................................ 18
Table 8-9. MedDRA Consecutive File: mdhier.seq .................................................................. 18
Table 8-10. MedDRA Consecutive File: intl_ord.seq ................................................................ 18
Table 9-1. Field Definitions in Consecutive Files ...................................................................... 22

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Introduction

1. INTRODUCTION
The MedDRA Distribution File Format Document contains information regarding the
MedDRA file schema and the Consecutive files which may be used to upgrade an
existing installation to the current version of MedDRA. This document will support theuser in creating and populating a relational database with the MedDRA andConsecutive files. Users of this document should have some knowledge of relational
databases to successfully import the MedDRA data to a usable database format.
The first section of this document contains the following information about the MedDRA
files:• General File Information – Overview of the MedDRA files included in this package• The MedDRA Schema – Information on the structure and attributes of the
MedDRA tables to be imported to the relational database• MedDRA Table Definition – Definition of each field in the MedDRA databasetables• MedDRA Table Joins – Definition of the table joins necessary to associate the
MedDRA database tables with each other• MedDRA Data Model – The complete data model for the MedDRA database.
The second section of this document contains information about the MedDRA
Consecutive files including:•General File Information – overview of the MedDRA consecutive files•

The MedDRA Consecutive File Description – information on the structure andattributes of the consecutive files•

Field Definitions – definitions of each field in each consecutive file.

Note: The SMQ files (smq_list and smq_content) contain data elements within the *.asc
files that identify changes resulting from MedDRA version updates. See Section 3
MedDRA Schema for more details.
Prior to MedDRA Version 16.0, this document was named the “ASCII and Consecutive
File Documentation”. The name was changed to the “MedDRA Distribution File Format
Document” to better reflect the contents of the document as not all translations of
MedDRA are encoded with the extended ASCII format.

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General File Information

2. GENERAL FILE INFORMATIONThis section lists the MedDRA data files in this package. Each MedDRA file is inextended ASCII format for English and most of the Western European languagetranslations. All other supported languages use UTF-8 file format. Table 2-1 lists the
MedDRA files and associated tables. The record counts for the files in Table 2-1 for agiven release may be found in the corresponding “What’s New” document for that
release.
File Name1
hlgt.asc
hlgt_hlt.asc
hlt.aschlt_pt.asc
llt.asc
meddra_history_english.asc
meddra_release.asc
mdhier.asc
pt.ascsoc.ascsoc_hlgt.asc
intl_ord.asc
smq_list.asc
smq_content.asc

MedDRA Table
1_hlgt_pref_term
1_hlgt_hlt_comp
1_hlt_pref_term
1_hlt_pref_comp
1_low_level_term
N/A*
N/A*
1_md_hierarchy
1_pref_term
1_soc_term
1_soc_hlgt_comp
1_soc_intl_order
1_smq_list
1_smq_content

Table 2-1. MedDRA Files
1

Record counts for the files above may be found in the “What’s New” document.

Data fields in the files appear in the same order as indicated in the MedDRA Schema(Section 3) for each table. Data is delimited by “$.” There is no ”$“ at the beginning of
the first field, however, there is a “$” after the last field.
*The meddra_history_english.asc and meddra_release.asc files are optional files foruse with the MedDRA Desktop Browser (MDB) release 3.0.2 Beta and up. These files
are not part of the MedDRA schema.
The meddra_history_english.asc file contains information that allows the MDB to display
the history of term addition, term deletion, term level change, term name change, and
LLT currency change in MedDRA. When new versions of MedDRA are released, thehistory data may be used to update the MDB to keep up with new changes. The history
function is available in MDB Beta 3.0.2 for English MedDRA only. Newer MDB versions
support all available languages. The history file contains a field for the MedDRA code,
the term name, what version (e.g., 10.1) the term was added, the type of term (e.g., PT,
HLGT), its currency status if it is an LLT, and an action code. The action code can beeither A (Add), U (Update), or D (Delete). See the table below.

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General File Information

Field Name

Field Attributes

term_code
term_nameterm_addition_version
term_type
llt_currency
actionlong integer, not nullchar (100), not nullchar(5), not nullchar (4), not nullchar (1)char (1), not null

Table 2-2. MedDRA History File: meddra_history_english.asc
The meddra_release.asc file contains version and language information for theaccompanying set of files that allows the MDB (Beta version 3.0.2 and up) to identify a
specific version and language when loading the files. Specifically, there is a field for the
MedDRA version (e.g., 13.1), one for the language (e.g., English, German, etc.) andthree null fields reserved for future use. See the table below.

Field Name

Field Attributes

versionlanguage
null_field
null_field
null_fieldchar (100), not nullchar (100), not nullchar (100)char (100)char (100)Table 2-3. MedDRA Release File: meddra_release.asc

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MedDRA Schema

3.

MedDRA SCHEMA

This section presents table and field information used for importing the MedDRA data toa relational database. Table Name, Field Names, Field Attributes, and Table Indexes
are provided for each MedDRA table. When importing the MedDRA data to a relational
database, create each table listed below and assign all field names and attributes
indicated. Field names should be applied in the order in which they appear in the file.
Indexes are also provided but may not be necessary depending on the software
package used.
Field Name
llt_code
llt_name
pt_codellt_whoart_code+
llt_harts_code+
llt_costart_sym+
llt_icd9_code+
llt_icd9cm_code+
llt_icd10_code+
llt_currency
llt_jart_code+
Index Name
ix1_pt_llt01
ix1_pt_llt02
ix1_pt_llt03

Field Attributes
long integer, not nullchar (100), not nulllong integer
char (7)long integer
char (21)char (8)char (8)char (8)char (1)char (6)Table Name
Field(s) to Index
1_low_level_term
llt_code
1_low_level_term
llt_name
1_low_level_term
pt_codeTable 3-1. 1_low_level_term Derived from MedDRA file: llt.asc+

Note: As of MedDRA v15.0 these fields contain no data. See section 4 for details.
Field Name
pt_codept_namenull_field
pt_soc_code
pt_whoart_code+
pt_harts_code+
pt_costart_sym+
pt_icd9_code+
pt_icd9cm_code+
pt_icd10_code+
pt_jart_code+
Index Name
ix1_pt01
ix1_pt02
ix1_pt03

Field Attributes
long integer, not nullchar (100), not nullchar (1)long integer
char (7)long integer
char (21)char (8)char (8)char (8)char (6)Table Name
1_pref_term
1_pref_term
1_pref_term

Field(s) to Index
pt_codept_namept_soc_code

Table 3-2. 1_pref_term Derived from MedDRA file: pt.asc+

Note: As of MedDRA v15.0 these fields contain no data. See section 4 for details.

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MedDRA Schema
Field Name
hlt_code
hlt_name
hlt_whoart_code+
hlt_harts_code+
hlt_costart_sym+
hlt_icd9_code+
hlt_icd9cm_code+
hlt_icd10_code+
hlt_jart_code+
Index Name
ix1_hlt01
ix1_hlt02

Field Attributes
long integer, not nullchar (100), not nullchar (7)long integer
char (21)char (8)char (8)char (8)char (6)Table Name
Field(s) to Index
1_hlt_pref_term
Hlt_code
1_hlt_pref_term
Hlt_name

Table 3-3. 1_hlt_pref_term Derived from MedDRA file: hlt.asc+

Note: As of MedDRA v15.0 these fields contain no data. See section 4 for details.

Field Name
hlt_code
pt_codeIndex Name
ix1_hlt_pt01
ix1_hlt_pt02

Field Attributes
long integer, not nulllong integer, not null
Table Name
Field(s) to Index
1_hlt_pref_comp
Hlt_code,pt_code
1_hlt_pref_comp
Pt_code, hlt_code

Table 3-4. 1_hlt_pref_comp Derived from MedDRA file: hlt_pt.asc
Field Name
hlgt_code
hlgt_namehlgt_whoart_code+
hlgt_harts_code+
hlgt_costart_sym+
hlgt_icd9_code+
hlgt_icd9cm_code+
hlgt_icd10_code+
hlgt_jart_code+
Index Name
ix1_hlgt01
ix1_hlgt02

Field Attributes
long integer, not nullchar (100), not nullchar (7)long integer
char (21)char (8)char (8)char (8)char (6)Table Name
Field(s) to Index
1_hlgt_pref_term
Hlgt_code
1_hlgt_pref_term
Hlgt_name

Table 3-5. 1_hlgt_pref_term Derived from MedDRA file: hlgt.asc+

Note: As of MedDRA v15.0 these fields contain no data. See section 4 for details.

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MedDRA Schema
Field Name
hlgt_code
hlt_code
Index Name
ix1_hlgt_hlt01
ix1_hlgt_hlt02

Field Attributes
long integer, not nulllong integer, not null
Table Name
Field(s) to Index
1_hlgt_hlt_comp
Hlgt_code, hlt_code
1_hlgt_hlt_comp
Hlt_code, hlgt_code

Table 3-6. 1_hlgt_hlt_comp Derived from MedDRA file: hlgt_hlt.asc
Field Name
soc_code
soc_name
soc_abbrev
soc_whoart_code+
soc_harts_code+
soc_costart_sym+
soc_icd9_code+
soc_icd9cm_code+
soc_icd10_code+
soc_jart_code+
Index Nameix1_soc01
ix1_soc02

Table Name
1_soc_term
1_soc_term

Field Attributes
long integer, not nullchar (100), not nullchar (5), not nullchar (7)long integer
char (21)char (8)char (8)char (8)char (6)Field(s) to Index
Soc_code
Soc_name

Table 3-7. 1_soc_term Derived from MedDRA file: soc.asc+

Note: As of MedDRA v15.0 these fields contain no data. See section 4 for details.

Field Name
soc_code
hlgt_code
Index Nameix1_soc_hlgt01
ix1_soc_hlgt02
ix1_soc_hlgt03

Field Attributes
long integer, not nulllong integer, not null
Table Name
Field(s) to Index
1_soc_hlgt_comp
Soc code, hlgt_code
1_soc_hlgt_comp
Soc_code
1_soc_hlgt_comp
Hlgt_code, soc_code

Table 3-8. 1_soc_hlgt_comp Derived from MedDRA file: soc_hlgt.asc

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MedDRA Schema
Field Name
pt_codehlt_code
hlgt_code
soc_code
pt_namehlt_name
hlgt_namesoc_name
soc_abbrev
null_field
pt_soc_code
primary_soc_fg
Index Name
ix1_md_hier01
ix1_md_hier02
ix1_md_hier03
ix1_md_hier04
ix1_md_hier05

Field Attributes
long integer, not nulllong integer, not nulllong integer, not nulllong integer, not nullchar (100), not nullchar (100), not nullchar (100), not nullchar (100), not nullchar (5), not nullchar (1)long integer
char (1)Table Name
Field(s) to Index
1_md_hierarchy
Pt_code1_md_hierarchy
Hlt_code
1_md_hierarchy
Hlgt_code
1_md_hierarchy
Soc_code
1_md_hierarchy
Pt_soc_code

Table 3-9. 1_md_hierarchy Derived from MedDRA file: mdhier.asc
Field Name
intl_ord_code
soc_code
Index Nameix1_intl_ord01

Field Attributes
long integer, not nulllong integer, not null
Table Name
Field(s) to Index
1_soc_intl_order
intl_ord_code, soc_code

Table 3-10. 1_soc_intl_order Derived from MedDRA file: intl_ord.asc

Field Name
smq_code
smq_name
smq_level
smq_description
smq_source
smq_note
MedDRA_version
statussmq_algorithm
Index Nameix1_smq_list01

Table Name
1_smq_list

Field Attributes
Long integer, not nullChar (100), not nullInteger, not null
VarChar*, not null
VarChar*
VarChar*Char (5), not nullChar (1), not null
VarChar, not null
Field(s) to Index
smq_code

Table 3-11. 1_smq_list Derived from MedDRA file: smq_list.asc*Note: The maximum field length of the variable character (VarChar) field is 2000 characters.

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MedDRA Schema

Field Name
smq_code
term_code
term_level
term_scope
term_categoryterm_weightterm_status
term_addition_version
term_last_ modified_version
Index Nameix1_smq_content01
ix1_smq_content02

Table Name
1_smq_content
1_smq_content

Field Attributes
Long integer, not nullLong integer, not nullInteger, not nullInteger, not nullChar (1), not nullInteger, not nullChar (1), not nullChar (5), not nullChar (5), not null
Field(s) to Index
smq_code
term_code

Table 3-12. 1_smq_Content Derived from MedDRA file: smq_content.asc

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Table Definition

4. TABLE DEFINITION
This section defines the fields in each MedDRA table.
Table Name
1_low_level_term

Field Name
llt_code
llt_name
pt_codellt_whoart_code+
llt_harts_code+
llt_costart_sym+
llt_icd9_code+
llt_icd9cm_code+

llt_icd10_code+
llt_currency

1_pref_term

llt_jart_code+
pt_codept_namenull_field
pt_soc_code
pt_whoart_code+
pt_harts_code+
pt_costart_sym+
pt_icd9_code+
pt_icd9cm_code+

pt_icd10_code+

1_hlt_pref_term

pt_jart_code+
hlt_code
hlt_name
hlt_whoart_code+
hlt_harts_code+
hlt_costart_sym+
hlt_icd9_code+
hlt_icd9cm_code+

hlt_icd10_code+

1_hlt_pref_comp
1_hlgt_pref_term

hlt_jart_code+
hlt_code
pt_codehlgt_code

Description
8-digit code to identify the Lowest Level Term
Full name of the Lowest Level Term
8-digit code to identify the Preferred Term
Code allocated by the WHO-ART© terminology
Code allocated by the HARTS© terminology
Symbol allocated by the COSTART© terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases, ICD-9
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification, ICD-9-CM©
Code allocated by the 10th Revision of theInternational Classification of Diseases, ICD-10©
Indicates whether the Lowest Level Term is current
or non-current
Code allocated by the J-ART terminology
8-digit code to identify the Preferred Term
Full name of the Preferred Term
This field is null
The primary System Organ Class to which thePreferred Term is linked
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology
8-digit code to identify the High Level Term
Full name of the High Level Term
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology
8-digit code to identify the High Level Term
8-digit code to identify the Preferred Term
8-digit code to identify the High Level Group Term

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Table Definition
Table Name

Field Name
hlgt_namehlgt_whoart_code+
hlgt_harts_code+
hlgt_costart_sym+
hlgt_icd9_code+
hlgt_icd9cm_code+

hlgt_icd10_code+

1_hlgt_hlt_comp
1_soc_term

hlgt_jart_code+
hlgt_code
hlt_code
soc_code
soc_name
soc_abbrev
soc_whoart_code+
soc_harts_code+
soc_costart_sym+
soc_icd9_code+
soc_icd9cm_code+

soc_icd10_code+

1_soc_hlgt_comp
1_md_hierarchy

1_soc_intl_order

soc_jart_code+
soc_code
hlgt_code
pt_codehlt_code
hlgt_code
soc_code
pt_namehlt_name
hlgt_namesoc_name
soc_abbrev
null_field
pt_soc_code
primary_soc_fg
intl_ord_code
soc_code

1_smq_list

smq_code
smq_name

Description
Full name of the High Level Group Term
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology
8-digit code to identify the High Level Group Term
8-digit code to identify the High Level Term
8-digit code to identify the System Organ Class
Full name of the System Organ Class
System Organ Class abbreviation
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology
8-digit code to identify the System Organ Class
8-digit code to identify the High Level Group Term
8-digit code to identify the Preferred Term
8-digit code to identify the High Level Term
8-digit code to identify the High Level Group Term
8-digit code to identify the System Organ Class
Full name of the Preferred Term
Full name of the High Level Term
Full name of the High Level Group Term
Full name of the System Organ Class
System Organ Class abbreviation
This field is null
The primary System Organ Class to which thePreferred Term is linked
Flag set to Y/N to indicate Primary SOC
Serial code for international System Organ Class
sort order8-digit code to identify the System Organ Class
Term
Eight-digit numeric code assigned to the SMQ,
which starts with “2”Name for the SMQ, each SMQ carries “(SMQ)” at
the end of the name

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Table Definition
Table Name

Field Name
smq_level

smq_description
smq_source
smq_note

MedDRA_version
statussmq_algorithm

1_smq_content

smq_code
term_code
term_level
term_scope

term_categoryterm_weightterm_status

term_addition_versi
onterm_last_modified_version

Description
Value between 1 and 5 identifying the level of the
SMQ within the hierarchy of SMQs; 1 is the mostgeneral, 5 is the most narrow
Description of the SMQ
Source for the development of the SMQ (e.g.,
medical references)
Note for users to better understand the scope anddevelopment process for the SMQ. The descriptionof the algorithm used is included (if applicable), as
well as the definition of categories
MedDRA version to use in conjunction with thisSMQ
Status of the SMQ. “A” = An active SMQ; “I” = An
inactive SMQ
If the SMQ was developed for use with an algorithm,
the Boolean expression of the algorithm is included.
“N” if the SMQ does not utilize an algorithm
Eight-digit code assigned to the SMQ
Subordinate term code; it could be a code for
MedDRA PT, LLT, or child SMQ
MedDRA hierarchy level of the term (4=PT, 5=LLT)
or 0 (zero) for a child SMQ
Defines the MedDRA term as a member of thebroad scope (1), narrow scope (2) of the SMQ
search, or a child SMQ (0) (zero)
The category is assigned a single alphabetical letter
depending upon the algorithm applied. If the SMQ
does not use algorithms, then all Term_category
values are assigned "A." For a child SMQ, this field
is assigned "S.”Term weight is used for some SMQ algorithms. “0”is used as default
Identifies a term as active within this SMQ orinactive within this SMQ. When a term is added toan SMQ, the value is set to “A” for Active. The term
can be flagged as “I” for inactive if the term is nolonger used in the SMQ.
Identifies the version of MedDRA in which this term
was added to the SMQ
Identifies the version of MedDRA in which this term
was last modified in this SMQ

Table 4-1. Field Definitions in MedDRA Files+

Note: As of MedDRA v15.0, the data in the legacy code fields (i.e., COSTART, WHO-ART, ICD-9, ICD9-CM, ICD-10, HARTS, and J-ART) have been removed from the MedDRA files. No MedDRA termnames or MedDRA codes have been modified or removed and the structure of the MedDRA files has notchanged. The removal of the codes is reflected in the consecutive files for MedDRA v15.0. A list of
MedDRA terms with the removed codes is available on the MedDRA Web site (login required) for
reference by MedDRA users.

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Table Joins

5. TABLE JOINSThis section describes the table joins for the MedDRA tables developed using the
MedDRA Schema. In the database, join the field listed for Table 1 to the field listed forTable 2.
Join Table 1
1_hlt_pref_comp
1_md_hierarchy
1_pref_term
1_hlgt_hlt_comp
1_hlgt_hlt_comp
1_soc_hlgt_comp
1_soc_term
1_md_hierarchy
1_hlt_pref_comp
1_soc_term
1_soc_intl_order
1_smq_list
1_smq_list
1_pref_term
1_low_level_term

Join Table 2
1_pref_term
1_low_level_term
1_low_level_term
1_hlt_pref_term
1_hlgt_pref_term
1_hlgt_pref_term
1_soc_hlgt_comp
1_pref_term
1_hlt_pref_term
1_pref_term
1_soc_term
1_smq_content
1_smq_content
1_smq_content
1_smq_content

Table 1 Field Name
pt_codept_codept_codehlt_code
hlgt_code
hlgt_code
soc_code
pt_codehlt_code
soc_code
soc_code
smq_code
smq_code
pt_codellt_code

Table 2 Field Name
pt_codept_codept_codehlt_code
hlgt_code
hlgt_code
soc_code
pt_codehlt_code
pt_soc_code
soc_code
smq_code
term_code
term_code
term_code

Table 5-1. Joins between each of the files

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Data Model

6. DATA MODEL
The MedDRA Data Model shows all tables and table joins for a complete MedDRA
database. Compare this model to the relational database created from the MedDRA
Schema and Table Joins to ensure accuracy.

soc_code

1_soc_intl_ order

1_soc_term
soc_code
soc_code

1_soc_
h lgt_comp

1_smq_list

hlgt_code
smq_code
1_hlgt_p ref_term

smq_code
term_code

hlgt_code
1_smq_
content

1_hlgt_hlt_comp
hlt_code

term_code

1_hlt_
pref_term
hlt_code
1_hlt_
pref_comp
pt_codept_soc_code
1_pref_term

llt_code
1_low_
level_term

pt_code1_md_hierarchy
pt_codept_codept_codeFigure 6-1. MedDRA Data Model

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Consecutive File Information

7. CONSECUTIVE FILE INFORMATIONThis section lists the MedDRA consecutive files. Each consecutive file is in extended
ASCII format for English and most of the Western European language translations. Allother supported languages use UTF-8 file format. Table 7-1 lists the consecutive files
and associated MedDRA tables. The record counts for the files in Table 7-1 for a given
release may be found in the corresponding “What’s New” document for that release.
File Name1
hlgt.seq
hlgt_hlt.seq
hlt.seq
hlt_pt.seq
llt.seq
mdhier.seq
pt.seqsoc.seq
soc_hlgt.seq
intl_ord.seq

MedDRA Table
1_hlgt_pref_term
1_hlgt_hlt_comp
1_hlt_pref_term
1_hlt_pref_comp
1_low_level_term
1_md_hierarchy
1_pref_term
1_soc_term
1_soc_hlgt_comp
1_soc_intl_order

Table 7-1. MedDRA Consecutive Files
1

Record counts for the files above may be found in the “What’s New” document.

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MedDRA Consecutive File Descriptions

8. MedDRA CONSECUTIVE FILE DESCRIPTIONSThis section describes the MedDRA consecutive files. MedDRA consecutive release
files contain only records that have changed since the last MedDRA release. Each fileconsists of records containing a version date for the new release and an action code
designating that the record was either “A” – added, “D” – removed, or “M” – modified.
Consecutive files can be identified by the *.seq extension to the file name. The filenames match the regular consolidated MedDRA data files that are also distributed withthe *.asc extension.
The "mod_fld_num" field, in the third position of each record, indicates which field(s)was modified. Only records with an action code of “M” have this field populated. For
records that do not contain "M" in the action field, the “mod_fld_num” field is left empty($$). Records with multiple modified fields have multiple numbers in this new field
separated by a space such as ($5 7$).
File name, field names, and field attributes for each MedDRA consecutive file areprovided below. Field definitions are provided in the next section of this document.
Data fields are delimited by “$.” There is no “$“ at the beginning of the first field,
however, there is a “$“ after the last field. Field names are listed in the order in which
the data appears in the file. With the exception of the first three fields per file, thesefiles have the same structure as the MedDRA data files (see Section 3. MedDRASCHEMA in this document for more information).
Field Names
llt_version_date
llt_action_code
llt_mod_fld_num
llt_code
llt_name
pt_codellt_whoart_code
llt_harts_code
llt_costart_sym
llt_icd9_code
llt_icd9cm_code
llt_icd10_code
llt_currency
llt_jart_code

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nullchar (100), not nulllong integer
char (7)long integer
char (21)char (8)char (8)char (8)char (1)char (6)Table 8-1. MedDRA Consecutive File: llt.seq

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MedDRA Consecutive File Descriptions
Field Names
pt_version_date
pt_action_code
pt_mod_fld_num
pt_codept_namenull_field
pt_soc_code
pt_whoart_code
pt_harts_code
pt_costart_sym
pt_icd9_code
pt_icd9cm_code
pt_icd10_code
pt_jart_code

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nullchar (100), not nullchar (1)long integer
char (7)long integer
char (21)char (8)char (8)char (8)char (6)Table 8-2. MedDRA Consecutive File: pt.seq
Field Names
hlt_version_date
hlt_action_code
hlt_mod_fld_num
hlt_code
hlt_name
hlt_whoart_code
hlt_harts_code
hlt_costart_sym
hlt_icd9_code
hlt_icd9cm_code
hlt_icd10_code
hlt_jart_code

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nullchar (100), not nullchar (7)long integer
char (21)char (8)char (8)char (8)char (6)Table 8-3. MedDRA Consecutive File: hlt.seq
Field Names
h_p_version_date
h_p_action_code
h_p_mod_fld_num
hlt_code
pt_codeField Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nulllong integer, not null

Table 8-4. MedDRA Consecutive File: hlt_pt.seq

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MedDRA Consecutive File Descriptions
Field Names
hlgt_version_date
hlgt_action_code
hlgt_mod_fld_num
hlgt_code
hlgt_namehlgt_whoart_code
hlgt_harts_code
hlgt_costart_sym
hlgt_icd9_code
hlgt_icd9cm_code
hlgt_icd10_code
hlgt_jart_code

Field Attributes
date, not null, dd/mm/yyyy
char (1)char (20)long integer, not nullchar (100), not nullchar (7)long integer
char (21)char (8)char (8)char (8)char (6)Table 8-5. MedDRA Consecutive File: hlgt.seq
Field Names
h_h_version_date
h_h_action_code
h_h_mod_fld_num
Hlgt_code
hlt_code

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nulllong integer, not null

Table 8-6. MedDRA Consecutive File: hlgt_hlt.seq

Field Names
soc_version_date
soc_action_code
soc_mod_fld_num
soc_code
soc_name
soc_abbrev
soc_whoart_code
soc_harts_code
soc_costart_sym
soc_icd9_code
soc_icd9cm_code
soc_icd10_code
soc_jart_code

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nullchar (100), not nullchar (5), not nullchar (7)long integer
char (21)char (8)char (8)char (8)char (6)Table 8-7. MedDRA Consecutive File: soc.seq

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MedDRA Consecutive File Descriptions
Field Names
s_h_version_date
s_h_action_code
s_h_mod_fld_num
soc_code
hlgt_code

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nulllong integer, not null

Table 8-8. MedDRA Consecutive File: soc_hlgt.seq
Field Names
md_version_datemd_action_code
md_mod_fld_num
pt_codehlt_code
hlgt_code
soc_code
pt_namehlt_name
hlgt_namesoc_name
soc_abbrev
null_field
pt_soc_code
primary_soc_fg

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nulllong integer, not nulllong integer, not nulllong integer, not nullchar (100), not nullchar (100), not nullchar (100), not nullchar (100), not nullchar (5), not nullchar (1)long integer
char (1)Table 8-9. MedDRA Consecutive File: mdhier.seq
Field Names
Intl_ord_version_date
Intl_ord_action_code
Intl_ord_mod_fld_num
Intl_ord_code
soc_code

Field Attributes
date, not null, dd/mm/yyyy
char (1), not nullchar (20)long integer, not nulllong integer, not null

Table 8-10. MedDRA Consecutive File: intl_ord.seq

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9. CONSECUTIVE FIELD DEFINITIONSThis section defines the fields in each MedDRA consecutive file.
File Names
llt.seq

Field Names
llt_version_date
llt_action_code
llt_mod_fld_num

llt_code
llt_name
pt_codellt_whoart_code
llt_harts_code
llt_costart_sym
llt_icd9_code
llt_icd9cm_code

llt_icd10_code
llt_currency

pt.seqllt_jart_code
pt_version_date
pt_action_code
pt_mod_fld_num

pt_codept_name
Null_field
pt_soc_code
pt_whoart_code
pt_harts_code
pt_costart_sym
pt_icd9_code
pt_icd9cm_code

pt_icd10_code
pt_jart_code

Description
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the Lowest Level Term
Full name of the Lowest Level Term
8-digit code to identify the Preferred Term
Code allocated by the WHO-ART© terminology
Code allocated by the HARTS© terminology
Symbol allocated by the COSTART© terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases, ICD-9©
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification, ICD-9-CM©
Code allocated by the 10th Revision of theInternational Classification of Diseases, ICD-10©
Indicates whether the Lowest Level Term is current
or non-current
Code allocated by the J-ART terminology
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the Preferred Term
Full name of the Preferred Term
This field is null
The primary System Organ Class to which thePreferred Term is linked
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology

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Consecutive Field Definitions
File Names
hlt.seq

Field Names
hlt_version_date
hlt_action_code
hlt_mod_fld_num

hlt_code
hlt_name
hlt_whoart_code
hlt_harts_code
hlt_costart_sym
hlt_icd9_code
hlt_icd9cm_code

hlt_icd10_code

hlt_pt.seq

hlt_jart_code
h_p_version_date
h_p_action_code
h_p_mod_fld_num

hlgt.seq

hlt_code
pt_codehlgt_version_date
hlgt_action_code
hlgt_mod_fld_num

hlgt_code
hlgt_namehlgt_whoart_code
hlgt_harts_code
hlgt_costart_sym
hlgt_icd9_code
hlgt_icd9cm_code

hlgt_icd10_code
hlgt_jart_code

Description
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the High Level Term
Full name of the High Level Term
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the High Level Term
8-digit code to identify the Preferred Term
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the High Level Group Term
Full name of the High Level Group Term
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology

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Consecutive Field Definitions
File Names
hlgt_hlt.seq

Field Names
h_h_version_date
h_h_action_code
h_h_mod_fld_num

soc.seq

hlgt_code
hlt_code
soc_version_date
soc_action_code
soc_mod_fld_num

soc_code
soc_name
soc_abbrev
soc_whoart_code
soc_harts_code
soc_costart_sym
soc_icd9_code
soc_icd9cm_code

soc_icd10_code

soc_hlgt.seq

soc_jart_code
s_h_version_date
s_h_action_code
s_h_mod_fld_num

md_hier.seq

soc_code
hlgt_code
md_version_datemd_action_code
md_mod_fld_num

pt_codehlt_code
hlgt_code

Description
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the High Level Group Term
8-digit code to identify the High Level Term
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the System Organ Class
Full name of the System Organ Class
System Organ Class abbreviation
Code allocated by the WHO-ART terminology
Code allocated by the HARTS terminology
Symbol allocated by the COSTART terminology
Code allocated by the 9th Revision of theInternational Classification of Diseases
Code allocated by the 9th Revision of theInternational Classification of Diseases, Clinical
Modification
Code allocated by the 10th Revision of theInternational Classification of Diseases
Code allocated by the J-ART terminology
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the System Organ Class
8-digit code to identify the High Level Group Term
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains a "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty. See
Section 8 for more information.
8-digit code to identify the Preferred Term
8-digit code to identify the High Level Term
8-digit code to identify the High Level Group Term

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Consecutive Field Definitions
File Names

Intl_ord.seq

Field Names
soc_code
pt_namehlt_name
hlgt_namesoc_name
soc_abbrev
null_field
pt_soc_code
primary_soc_fg
intl_ord_version_date
Intl_ord_action_code
Intl_ord_mod_fld_num

intl_ord_code
soc_code

Description
8-digit code to identify the System Organ Class
Full name of the Preferred Term
Full name of the High Level Term
Full name of the High Level Group Term
Full name of the System Organ Class
System Organ Class abbreviation
This field is null
The primary System Organ Class to which thePreferred Term is linked
Flag set to Y/N to indicate Primary SOC
Date when MedDRA version was released,
dd/mm/yyyy
Indicates record was added, deleted, or modified
Indicates a field number for each field that is
modified when the record contains an "M" in theaction field of the record. Records that do notcontain "M" in the action field will be left empty
Serial code for international SOC sort order8-digit code to identify the System Organ Class

Table 9-1. Field Definitions in Consecutive Files

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