Summary of Changes to
MedDRA® DATA RETRIEVAL
AND PRESENTATION:
POINTS TO CONSIDER
ICH-Endorsed Guide for MedDRA Users on
Data Output
Release 3.4
Based on MedDRA Version 15.1
1 October 2012
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The following is a listing of changes made between releases 3.3 and 3.4 of Data
Retrieval and Presentation: Points to Consider:
Throughout document
1) Correction of general spelling, punctuation, spacing, figure numbering,
and format errors
2) Replacement of references to MedDRA Version 15.0 to Version 15.1
3) Update of examples based on MedDRA version changes
Title page
The original copyright statement and IFPMA contact information has been
replaced with an updated disclaimer, copyright notice and MedDRA trademark
statement.
2.5.3.1 Primary SOC assignment rules
In the Example table:
Example
Type of Disorder
Congenital
Infectious
Primary SOC Rule
Example
PT Congenital
All terms for
absence of bile
congenital
disorders have as ducts has a primary
their primary SOC SOC assignment of
SOC Congenital,
assignment SOC
Congenital, familial familial and genetic
and genetic
disorders and a
disorders
secondary SOC
assignment of SOC
Hepatobiliary
disorders
PT Enterocolitis
All terms for
infectious has a
infectious
disorders have as
primary SOC
their primary SOC assignment of SOC
Comment
The secondary SOC
assignment for these
terms is their “site of
manifestation” SOC
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Type of Disorder
Primary SOC Rule
assignment SOC
Infections and
infestations
Neoplastic
All terms for
malignant and
benign neoplasms
(except cysts and
polyps) have as
their primary SOC
assignment SOC
Neoplasms benign,
malignant and
unspecified (incl
cysts and polyps)
Example
Infections and
infestations and a
secondary SOC
assignment of SOC
Gastrointestinal
disorders
PT Skin cancer has
a primary SOC
assignment of SOC
Neoplasms benign,
malignant and
unspecified (incl
cysts and polyps)
and a secondary
SOC assignment of
SOC Skin and
subcutaneous
tissue disorders
Comment
Cyst and polyp terms
are an exception to
this rule. The primary
SOC assignment for
cyst and polyp terms is
the “site of
manifestation” SOC,
and the secondary SOC
is SOC Neoplasms
benign, malignant and
unspecified (incl cysts
and polyps)
The order of the entries in the “Type of Disorder” column was changed as
follows:
Example
Type of Disorder
Congenital
Primary SOC Rule
Example
PT Congenital
All terms for
absence of bile
congenital
disorders have as ducts has a primary
their primary SOC SOC assignment of
SOC Congenital,
assignment SOC
Congenital, familial familial and genetic
and genetic
disorders and a
disorders
secondary SOC
assignment of SOC
Hepatobiliary
disorders
Comment
The secondary SOC
assignment for these
terms is their “site of
manifestation” SOC
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Type of Disorder
Neoplastic
Primary SOC Rule
All terms for
malignant and
benign neoplasms
(except cysts and
polyps) have as
their primary SOC
assignment SOC
Neoplasms benign,
malignant and
unspecified (incl
cysts and polyps)
Infectious
All terms for
infectious
disorders have as
their primary SOC
assignment SOC
Infections and
infestations
Example
PT Skin cancer has
a primary SOC
assignment of SOC
Neoplasms benign,
malignant and
unspecified (incl
cysts and polyps)
and a secondary
SOC assignment of
SOC Skin and
subcutaneous
tissue disorders
PT Enterocolitis
infectious has a
primary SOC
assignment of SOC
Infections and
infestations and a
secondary SOC
assignment of SOC
Gastrointestinal
disorders
Comment
Cyst and polyp terms
are an exception to
this rule. The primary
SOC assignment for
cyst and polyp terms is
the “site of
manifestation” SOC,
and the secondary SOC
is SOC Neoplasms
benign, malignant and
unspecified (incl cysts
and polyps)
The secondary SOC
assignment for these
terms is their “site of
manifestation” SOC
In addition, the following wording was added after the Example table:
If a PT links to more than one of these three SOCs, the following priority is
used to determine the primary SOC:



SOC Congenital, familial and genetic disorders
SOC Neoplasms benign, malignant and unspecified (incl cysts and
polyps)
SOC Infections and infestations
2.6 – MedDRA Versioning
Wording in the third paragraph:
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Both simple and complex changes impact retrieval and presentation
strategies. Users should read the documentation provided with each
MedDRA release, especially the What’s New document and the MedDRA
version report. These documents, provided by the MSSO and JMO, list
MedDRA changes in detail. Organizations should plan and document
their strategy for handling MedDRA version updates. When planning or
performing data retrieval and presentation, the MedDRA version used
should be documented.
Was changed as follows:
Both simple and complex changes impact retrieval and presentation
strategies. Users should read the documentation provided with each
MedDRA release, especially the What’s New document. The MSSO and
JMO provide tools to assist the user in comparing the changes between
MedDRA versions. The Version Report (provided by the MSSO and JMO)
is a spreadsheet listing all changes between the current version of
MedDRA and the one previous to it; this spreadsheet is provided with
each new release of MedDRA. The MSSO also provides the MedDRA
Version Analysis Tool (MVAT) that facilitates identification and
understanding of the impact of changes between any two MedDRA
versions, including non-consecutive ones. (See Appendix, Section 6.1 of
this document; also, see Section 4.1.1 of the MedDRA Term Selection:
Points to Consider document).
Organizations should plan and document their strategy for handling
MedDRA version updates. When planning or performing data retrieval
and presentation, the MedDRA version used should be documented.
In addition, the Example tables in this section:
Example
Impact of Version Changes – Demoted PT
PT Operative haemorrhage was included in a query developed using terms in
MedDRA Version 14.1. If the query had been re-run on data using MedDRA
Version 15.0, these events would not have been found at the PT level
because PT Operative haemorrhage had been demoted to an LLT and linked
to PT Procedural haemorrhage. See Figure 3.
Example
Impact of Version Changes – Change of Primary SOC Assignment
PT Diaphragmatic hernia had a primary link to SOC Respiratory, thoracic and
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Impact of Version Changes – Change of Primary SOC Assignment
mediastinal disorders and a secondary link to SOC Gastrointestinal disorders
in MedDRA Version 14.1. In Version 15.0, the primary SOC assignment was
changed to SOC Gastrointestinal disorders and the secondary assignment to
SOC Respiratory, thoracic and mediastinal disorders. In a primary SOC
output of data, PT Diaphragmatic hernia will seem to have “disappeared”
from SOC Respiratory, thoracic and mediastinal disorders.
Were changed as follows:
Example
Impact of Version Changes – Demoted PT
PT Cytolytic hepatitis was included in a query developed using terms in
MedDRA Version 15.0. If the query had been re-run on data using MedDRA
Version 15.0, these events would not have been found at the PT level
because PT Cytolytic hepatitis had been demoted to an LLT and linked to PT
Hepatitis. See Figure 3.
Example
Impact of Version Changes – Change of Primary SOC Assignment
PT Oropharyngeal scar had a primary link to SOC Gastrointestinal disorders
and a secondary link to SOC Respiratory, thoracic and mediastinal disorders
in MedDRA Version 15.0. In Version 15.1, the primary SOC assignment was
changed to SOC Respiratory, thoracic and mediastinal disorders and the
secondary assignment to SOC Gastrointestinal disorders. In a primary SOC
output of data, PT Oropharyngeal scar will seem to have “disappeared” from
SOC Gastrointestinal disorders.
4.5 – SMQs and MedDRA Version Changes
The Example table in this section:
Example
Consequence of Version Mismatch of Coded Data and SMQ
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Consequence of Version Mismatch of Coded Data and SMQ
PT Prerenal failure was added to SMQ Acute renal failure in MedDRA
Version 15.0. Using Version 14.1 of this SMQ – which does not contain this
PT – would fail to identify cases coded to this term in a database using
MedDRA Version 15.0.
Was changed as follows:
Example
Consequence of Version Mismatch of Coded Data and SMQ
PT Uveitic glaucoma was added to SMQ Glaucoma in MedDRA Version 15.1.
Using Version 15.0 of this SMQ – which does not contain this PT – would fail
to identify cases coded to this term in a database using
MedDRA Version 15.1.
6.1 – Links and References
Two new links were added to this table as follows:
Document
MedDRA Version
Report (lists all
changes in new
version) *
MedDRA Version
Analysis Tool
(compares any
two versions) *
Link
https://meddramsso.com/secure/subscriber_download_tr
anslations.asp
http://www.meddramsso.com/subscriber_download_tools
_mvat.asp
* Requires user ID and password to access
6.2.1 Current members of the ICH Points to Consider Working Group
Morell David’s name was replaced by Sarah Vaughan’s for the Commission of
the European Communities membership.
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The names of Nogusa Takahara, Daisuke Tanaka and Go Yamamato were
replaced by Shinichi Okamura, Makiko Isozaki, Hideyuki Kondou and Shinichi
Watanabe for the Ministry of Health, Labour and Welfare membership.
Susan M. Lorenski’s name was replaced by Anna-Lisa Kleckner for the
Pharmaceutical Research and Manufacturers of America membership.
Toni Piazza-Hepp’s name was removed for the US Food and Drug
Administration membership.
6.2.2 Former members of the ICH Points to Consider Working Group
Morell David’s name was added for the Commission of the European
Communities membership.
The names of Nogusa Takahara, Daisuke Tanaka and Go Yamamato were
added for the Ministry of Health, Labour and Welfare membership.
Susan M. Lorenski’s name was added for the Pharmaceutical Research and
Manufacturers of America membership.
Toni Piazza-Hepp’s name was added for the US Food and Drug Administration
membership.
6.3 Figures
Figure 3: The examples (related to MedDRA version changes) for this figure:
Preferred Terms
Operative
haemorrhage
Events/Cases
Version 14.1
Version 15.0
15
0 (no
longer a
PT)
Procedural
haemorrhage
5
Comment
In MedDRA Version 14.1,
Operative haemorrhage was a PT
and in Version 15.0 it was
demoted to an LLT under PT
Procedural haemorrhage
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Figure 3 – Impact of MedDRA version changes – demotion of a PT
Were changed as follows:
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Preferred Terms
Cytolytic hepatitis
Hepatitis
Events/Cases
Comment
Version 15.0
Version 15.1
In MedDRA Version 15.0,
15
0 (no
Cytolytic hepatitis was a PT and in
longer a
PT)
Version 15.1 it was demoted to an
LLT under PT Hepatitis.
5
20
Figure 3 – Impact of MedDRA version changes – demotion of a PT
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