Summary of Changes to
MedDRA® DATA RETRIEVAL
AND PRESENTATION:
POINTS TO CONSIDER
ICH-Endorsed Guide for MedDRA Users on
Data Output
Release 3.3
Based on MedDRA Version 15.0
1 April 2012
The following is a listing of changes made between releases3.2 and 3.3 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 14.1 to Version 15.0
3)Update of examples based on MedDRA version changes
4)Links to the MSSO Web site have been updated
2.5.2 Granularity
The wording in the first paragraph:
Figure 1 illustrates how data coded to a single PT from another terminology may be coded to several PTs in MedDRA.
Was changed as follows (“PT” was replaced with the word “concept”):
Figure 1 illustrates how data coded to a single concept from another terminology may be coded to several PTs in MedDRA.
2.5.3 .1 Primary SOC assignment rules
The “Congenital Events” and “Infectious Events” examples tables:
Example
Congenital EventsAll terms for congenital events have as their primary SOC assignment SOC Congenital, familial and genetic disorders.
Example
Infectious EventsThe primary SOC assignment for PT Enterocolitis infectious is SOC Infections and infestations (with a secondary SOC assignment of SOC Gastrointestinal disorders) while the primary SOC assignment for PT Enterocolitis is SOC Gastrointestinal disorders.
Were consolidated into a single table, and a third example related to neoplastic disorders was added; additionally, a PT example (PT Congenital absence of bile ducts) was inserted for “Congenital” disorders:
Type of Disorder / Primary SOC Rule / Example / CommentCongenital / All terms for congenital disorders have as their primary SOC assignment SOC Congenital, familial and genetic disorders / PT Congenital absence of bile ducts has a primary SOC assignment of SOC Congenital, familial and genetic disorders and a secondary SOC assignment of SOC Hepatobiliary disorders / The secondary SOC assignment for these terms is their “site of manifestation” SOC
Infectious / All terms for infectious disorders have as their primary SOC assignment SOC Infections and infestations / PT Enterocolitis infectious has a primary SOC assignment of SOC Infections and infestations and a secondary SOC assignment of SOC Gastrointestinal disorders
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) / 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 / 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)
2.6 – MedDRA Versioning
The two example tables:
Example
Impact of Version Changes – Demoted PTPT Reflux oesophagitis was included in a query developed using terms in MedDRA Version 14.0. If the query had been re-run on data using MedDRA Version 14.1, these events would not have been found at the PT level because PT Reflux oesophagitis had been demoted to an LLT and linked to PT Gastrooesophageal reflux disease. See Figure 3.
Example
Impact of Version Changes – Change of Primary SOC AssignmentPT Corneal scar had a primary link to SOC Injury, poisoning and procedural complicationsand a secondary link to SOC Eye disordersin MedDRA Version 14.0. In Version 14.1, the primary SOC assignment was changed to SOC Eye disorders and the secondary assignment to SOC Injury, poisoning and procedural complications. In a primary SOC output of data, PT Corneal scar will seem to have “disappeared” from SOC Injury, poisoning and procedural complications.
Werechanged as follows:
Example
Impact of Version Changes – Demoted PTPT 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 AssignmentPT Diaphragmatic hernia had a primary link to SOC Respiratory, thoracic and mediastinal disordersand a secondary link to SOC Gastrointestinal disordersin 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 SOCRespiratory, thoracic and mediastinal disorders.
3.2.1 Overview by primary System Organ Class
Wording in the sixth paragraph:
Graphical displays (histograms, bar charts, pie charts, etc.) may facilitate understanding of data by the viewer. Figures 6 and 7 are examples of such displays.
Was changed as follows:
Data displays in tables or in graphical presentations may facilitate understanding by the viewer. Figures 6, 7 and 8 are examples of such displays.
4.5 – SMQs and MedDRA Version Changes
The example table in this Section:
Example
Consequence of Version Mismatch of Coded Data and SMQPT Diastolic dysfunction was added to SMQ Cardiac failurein MedDRA Version 14.1. Using Version 14.0 of this SMQ – which does not contain this PT – would fail to identify cases coded to this term in a database using
MedDRA Version 14.1.
Was changed as follows:
Example
Consequence of Version Mismatch of Coded Data and SMQPT Prerenal failure was added to SMQ Acute renal failurein 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.
4.10.1Narrow and broad searches
A reference to a new Figure 12 was added to the end of the first paragraph in this section.
5.1 – Modified MedDRA Query Based on an SMQ
The following wording related to a combination product (related to “Additional PTs are needed”) was removed from the example table:
A combination product (drug and device) is being investigated for possible lack of efficacy. SMQ Lack of efficacy/effect does not include PT Device failure. When documenting a search, indicate that PT Device failure has been added.
6.1 – Links and References
The links for the MedDRA Introductory Guide and for the Introductory Guide for Standardised MedDRA Queries:
Document / LinkMedDRA Introductory Guide /
Introductory Guide for Standardised MedDRA Queries (SMQs) /
Were changed as follows:
Document / LinkMedDRA Introductory Guide /
Introductory Guide for Standardised MedDRA Queries (SMQs) /
6.2.1 Current members of the ICH Points to Consider Working Group
Carmen Kreft-Jais’s name was replaced by Maria Luisa Casini’s for the Commission of the European Communities membership.
Judy Harrison’s name was addedfor the MedDRA MSSO membership.
Izuma Oba’s name was replaced by Nogusa Takahara’s for the Ministry of Health, Labour and Welfare membership.
Go Yamamoto’s name was addedfor the Ministry of Health, Labour and Welfare membership.
6.2.2 Former members of the ICH Points to Consider Working Group
Carmen Kreft-Jais’s name was addedfor the Commission of the European Communities membership.
Izuma Oba’s name was added for the Ministry of Health, Labour and Welfare membership.
6.3 Figures
Figure 1: The wording in the caption:
How data coded to a single PT from another terminology may be expressed by several PTs in MedDRA
Was changed as follows (“PT” was replaced with the word “concept”):
How data coded to a single concept from another terminology may be expressed by several PTs in MedDRA
Figure 3: The examples (related to MedDRA version changes), caption wording, and format of this figure:
MedDRA Version 14.0 / Number of Eventsat PT Level
Reflux oesophagitis (PT) / 15
Gastrooesophageal reflux disease / 5
MedDRA Version 14.1 / Number of Events
at PT Level
Reflux oesophagitis (no longer a PT) / 0
Gastrooesophageal reflux disease / 20
Figure 3 – In MedDRA Version 14.0, Reflux oesophagitiswas a PT and in Version 14.1 it was demoted to an LLT
Were changed as follows:
Preferred Terms / Events/Cases / CommentVersion 14.1 / Version 15.0
Operative haemorrhage / 15 / 0
(no longer
a PT) / 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
Procedural haemorrhage / 5 / 20
Figure 3 – Impact of MedDRA version changes – demotion of a PT
Figure 4: The existing figure:
SOC Cardiac disorders 22
HLGT Cardiac arrhythmias
HLT Supraventricular arrhythmias
PT Atrial tachycardia 22
LLT Paroxysmal atrialtachycardia 9
LLT Tachycardia atrial 10
LLT Tachycardia paroxysmal atrial 3
SOC Investigations 10
HLGT Enzyme investigations NEC
HLT Skeletal and cardiac muscle analyses
PT Blood creatine phosphokinase MB increased 10
LLT Blood creatine phosphokinase MB increased 2
LLT CPK-MB increased 2
LLT Plasma creatine phosphokinase MB increased 5
LLT Serum creatine phosphokinase MB increased 1
Figure 4 – Primary SOC output listing - example
Was deleted and replaced with a new Figure 4 as follows (note that the caption wording also changed):
Figure 4 – Primary SOC output listing – example. Note that some PTs are multi-axial, however, this figure shows only the primary SOC assignments
Figure 6: The existing figure:
Figure 6 – Example of a graphical display (frequency by primary SOC)
Was deleted and replaced with a new Figure 6 as follows:
Figure 6 – Example of a graphical display (frequency by primary SOC)
Figure 8: This new figure was added:
Figure 8 – Example of a tabular display (frequency by primary SOC)
Figure 10: The existing figure:
Incidence of treatment-emergent adverse events coded by MedDRA 14.1
Population: Patients Valid for Safety
System Organ Class / Active / ControlHigh Level Term / (N=21) / (N=19)
Preferred Term
Any System Organ Class
Any High Level Term
Any event / 3 / 14.3% / 1 / 5.3%
Cardiac disorders
Any High Level Term
Any event / 2 / 9.5% / 1 / 5.3%
Ventricular arrhythmias and cardiac arrest
Any event / 2 / 9.5% / 1 / 5.3%
[2] Sudden death / 2 / 9.5% / 1 / 5.3%
General disorders and administration site conditions
Any High Level Term
Any event / 3 / 14.3% / 1 / 5.3%
Any primary path / 2 / 9.5% / 1 / 5.3%
Death and sudden death
Any event / 2 / 9.5% / 1 / 5.3%
Any primary path / 2 / 9.5% / 1 / 5.3%
[1] Sudden death / 2 / 9.5% / 1 / 5.3%
Febrile disorders
Any event / 2 / 9.5% / 0 / 0.0%
[2] Postoperative fever / 2 / 9.5% / 0 / 0.0%
Injury, poisoning and procedural complications
Any High Level Term
Any event / 2 / 9.5% / 0 / 0.0%
Any primary path / 2 / 9.5% / 0 / 0.0%
Non-site specific procedural complications
Any event / 2 / 9.5% / 0 / 0.0%
Any primary path / 2 / 9.5% / 0 / 0.0%
[1] Postoperative fever / 2 / 9.5% / 0 / 0.0%
Note:Sorted first by System Organ Class (alphab. order), then by High Level Term (alphab. order), then by Preferred Term (alphab. order).
Note:The table presents MedDRA terms of all paths.
Note:[1] means primary path, [2] means secondary path.
Figure 10 – Primary and secondary SOC output
Was deleted.
Figure 12 was added as follows:
Asthma/bronchospasm (SMQ) Cases – Narrow Search
(since 1-JAN-2008)
ID MedDRA_PT REPORT_VERBATIM DATE_CREATED
------
045AsthmaAsthma attack01-APR-2008
063AsthmaSevere asthma10-JUN-2008
060Asthma exercise induced Asthma when exercising30-MAY-2008
091 BronchospasmSpasms, bronchial 12-AUG-2008
074BronchospasmBronchoconstriction 03-JUL-2008
100Bronchial hyperreactivityAirways hyperreactive20-SEP-2008
069Bronchial hyperreactivityReactive airways disease21-JUN-2008
Asthma/bronchospasm (SMQ) Cases – Broad Search
(since 1-JAN-2008)
ID MedDRA_PT REPORT_VERBATIM DATE_CREATED
------
023Allergic respiratory disease Respiratory (allergy) disorder18-FEB-2008
045AsthmaAsthma attack01-APR-2008
063AsthmaSevere asthma10-JUN-2008
060Asthma exercise induced Asthma when exercising30-MAY-2008
016 Bronchial obstructionBronchial obstruct.16-JAN-2008
039Bronchial obstructionBronchus obstruction 14-MAR-2008
091 BronchospasmSpasms, bronchial 12-AUG-2008
074BronchospasmBronchoconstriction 03-JUL-2008
100Bronchial hyperreactivityAirways hyperreactive20-SEP-2008
069Bronchial hyperreactivityReactive airways disease21-JUN-2008
088Obstructive airways disorder Obstructive airways disorder29-JUL-2008
049Obstructive airways disorder Obstructed airways dis.20-APR-2008
022WheezingWheeze16-FEB-2008
031WheezingWheezes02-MAR-2008
106WheezingWheezing28-SEP-2008
046WheezingWheezing (acute)06-APR-2008
Figure 12 – Results of Narrow and Broad SMQ Searches
1