3/28/2024

Data Analysis and Query

Building with MedDRA

MedDRA was developed under the auspices of the

International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use
(ICH). The activities of the MedDRA Maintenance
and Support Services Organization (MSSO) are
overseen by an ICH MedDRA Management
Committee, which is composed of the ICH parties,
the Medicines and Healthcare products Regulatory
Agency (MHRA) of the UK, Health Canada, and the
WHO (as Observer).

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Disclaimer &
Copyright Notice

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Course Overview

• Discuss topics in the MedDRA Data Retrieval and

Presentation: Points to Consider document
• Discuss applications of MedDRA in data retrieval,
presentation, and analysis
• Discuss and demonstrate the use of MedDRA for
developing queries
• Conclude with a question and answer session

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MedDRA Data Retrieval and

Presentation: Points to Consider
Document

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MedDRA Data Retrieval and

Presentation: Points to Consider
(DRP:PTC)

• Provides data retrieval and

presentation options for
industry or regulatory purposes
• Most effective when used in
conjunction with MedDRA Term
Selection: PTC document
• Recommended to be used as
basis for individual
organization’s own data
retrieval conventions

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MedDRA Data Retrieval and

Presentation: PTC (cont)
• Developed by a working group of the ICH
Management Committee
• Updated annually in March
• Complete versions available in
– English, Japanese, Chinese, Korean, Spanish, and Russian
• Condensed versions available for other MedDRA
languages*
• Available on MedDRA and JMO websites

*Arabic, Brazilian Portuguese, Czech, Dutch, French, German, Hungarian, Italian,

Portuguese
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Data Retrieval and

Presentation : PTC
Points Addressed
• General Principles
– Quality of Source Data
– Documentation of Data Retrieval and Presentation Practices
– Do Not Alter MedDRA
– Organisation-Specific Data Characteristics
– Characteristics of MedDRA that Impact Data Retrieval and Analysis
– MedDRA Versioning
• General Queries and Retrieval
• Standardised MedDRA Queries
• Customised Searches

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DRP:PTC General Principles

• Quality of Source Data

• High quality data output is dependent on maintaining

quality of original information reported
(Refer to MedDRA Term Selection: Points to Consider document)

• Method of conversion of data into MedDRA might impact

retrieval and presentation
– Legacy data conversion using verbatims
– Legacy data conversion using coded terms

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DRP:PTC General Principles

• Documentation of Data Retrieval

and Presentation Practices
• Organisation-specific guidelines
– Consistent with Points to Consider documents
– Coding conventions
– Data retrieval and output strategies (including SMQs)
– Quality assurance procedures
– MedDRA version used for search
– Search strategy methods
– Version update processes
– Processes for customised MedDRA queries
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DRP:PTC General Principles

• Do Not Alter MedDRA

• MedDRA is a standardized terminology with a pre-

defined term hierarchy
• Users must not make ad hoc structural alterations,
including changing the primary SOC allocation

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DRP:PTC General Principles

• Organisation-Specific Data Characteristics

• Database structure (storage and use of hierarchy)

• Data storage (level of term, synonym/reported term)
• Data conversion (if applicable)
• Coding practices over time
• Limitations/restrictions (inability to view secondary SOCs)
• Term selection principles
– More than one term selected increases counts
– Diagnosis term only selected reduces counts
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DRP:PTC General Principles

• Impact of MedDRA’s Characteristics – Grouping
Terms
HLGTs and HLTs provide clinically relevant groupings

SOC Cardiac disorders

HLGT
Cardiac arrhythmias

HLT  Cardiac conduction disorders

 Rate and rhythm disorders NEC
 Supraventricular arrhythmias
 Ventricular arrhythmias and cardiac arrest

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DRP:PTC General Principles

• Impact of MedDRA’s Characteristics – Grouping
Terms
Ensure all terms are relevant to output

HLT Vascular tests NEC (incl blood pressure)

PT Blood pressure decreased
PT Blood pressure increased

Related PTs in different locations in SOC

HLT Bullous conditions

PT Stevens-Johnson syndrome

HLT Exfoliative conditions

PT Dermatitis exfoliative
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Multi-Axiality
Primary SOC allocation rules affect the way data
are distributed across the terminology

Impact on frequencies of medical condition of

interest should be considered

Example: For renal abnormality, search in

 SOC Renal and urinary disorders,
 SOC Investigations (laboratory test terms associated with renal disease),
 SOC Surgical and medical procedures (e.g., PT Renal transplant)
 SOC Social circumstances (e.g., PT Artificial kidney device user)

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Multi-Axiality (cont)

Main presentation is by Primary SOC

Secondary SOCs used for alternate views and

presentation of data

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Which Level? –
SOC Investigations
Adverse Event (MedDRA v23.0) 25 mg MyDrug Placebo
(N=44) (N=15)
SOC Investigations 13 (29.5%) 2 (13.3%)
PT Aspartate aminotransferase increased 6 0
PT Alanine aminotransferase increased 5 0
PT Gamma-glutamyltransferase increased 4 0
PT Blood creatine phosphokinase increased 2 1
PT Blood alkaline phosphatase increased 2 0
PT Blood glucose increased 1 1
PT Blood lactate dehydrogenase increased 2 0
PT Lipase increased 2 0
PT White blood cell count decreased 2 0
PT Amylase increased 1 0
PT Faecal fat increased 0 1

Patients may have more than one event reported

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Which Level? –
SOC Investigations (cont)
Adverse Event (MedDRA v23.0) 25 mg MyDrug Placebo
(N=44) (N=15)
SOC Investigations 13 (29.5%) 2 (13.3%)
PT Blood pressure increased 1 0
PT Blood urea increased 1 0
PT Occult blood positive 1 0
PT Liver function test abnormal 1 0
PT Monocyte count decreased 1 0
PT Protein urine present 1 0

Patients may have more than one event reported

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Which Level? –
SOC Investigations (cont)
Adverse Event (MedDRA v23.0) 25 mg MyDrug Placebo
(N=44) (N=15)
SOC Investigations 13 (29.5%) 2 (13.3%)
HLT Liver function analyses 16 0
HLT Tissue enzyme analyses NEC 4 0
HLT Digestive enzymes 3 0
HLT White blood cell analyses 3 0
HLT Skeletal and cardiac muscle analyses 2 1
HLT Carbohydrate tolerance analyses (incl 1 1
diabetes)
HLT Faecal analyses NEC 1 1
HLT Vascular tests NEC (incl blood pressure) 1 0
HLT Renal function analyses 1 0
HLT Urinalysis NEC 1 0
Patients may have more than one event reported

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DRP:PTC General Principles

• MedDRA Versioning

• MedDRA is updated twice a year

– 1 March X.0 release (all levels)
– 1 September X.1 release (LLT and PT levels only)
• Version used in data retrieval and presentation
should be documented
• Resources:
– “What’s New” document
– Version report
– MedDRA Version Analysis Tool (MVAT)
• Terms used for queries should be in same version as
data being queried
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MedDRA Versioning (cont):

Effect of PT Demotion

MedDRA Version 22.1 Number of Events at

PT Level

Fractured ischium (PT) 15

Pelvic fracture 5

MedDRA Version 23.0 Number of Events at

PT Level

Fractured ischium (no longer a PT) 0

Pelvic fracture 20

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MedDRA Versioning (cont):

Effect of Primary SOC
Change
MedDRA Version 22.1 Number of Events

SOC Psychiatric disorders 20

PT Vascular cognitive impairment

MedDRA Version 23.0 Number of Events

SOC Psychiatric disorders 0

SOC Nervous system disorders 20

PT Vascular cognitive impairment

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MedDRA Version Analysis

Tool (MVAT)

• Web-based (https://tools.meddra.org/mvat)
• Free to all users
• Features
– Version Report Generator (produces exportable report
comparing any two versions)
– Data Impact Report (identifies changes to a specific set
of MedDRA terms or codes uploaded to MVAT)
– Search Term Change (identifies changes to a single
MedDRA term or code)

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MedDRA Version Analysis

Tool (MVAT) (cont)

• User interface and report output available in all

MedDRA languages
• Ability to run reports on supplemental changes
• Option to run reports on secondary SOC changes
• Watch the two-part webinar on the use of MVAT under
“Tools” tab on the “Training Materials” page of
MedDRA website
https://www.meddra.org/training-materials

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MVAT Demonstration (Optional)

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Use of MedDRA in Data Retrieval,

Presentation, and Analysis

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Overview by Primary SOC

• Use Internationally Agreed Order of SOCs when

applicable, e.g., the EU SPC guideline
– See MedDRA Introductory Guide, ASCII files
• Consider use of HLTs and HLGTs
• Line listings, tables, graphs
Benefits - Broad overview, PTs displayed only once

Limitations - Incomplete groupings due to SOC

allocation rules, lengthy output
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Primary SOC Graphical

Display Example

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Primary SOC Output

Listing Example
SOC Nervous system disorders 8
HLGT Mental impairment disorders
HLT Mental impairment (excl dementia and memory loss)
PT Disturbance in attention 1
HLGT Movement disorders (incl Parkinsonism)
HLT Dyskinesias and movement disorders NEC
PT Psychomotor hyperactivity 2
HLT Tremor (excl congenital)
PT Tremor 3
HLGT Neurological disorders NEC
HLT Disturbances in consciousness NEC
PT Somnolence 1
HLT Neurological signs and symptoms NEC
PT Dizziness 1

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Focused Searches
Useful when further investigating concepts of interest

• Secondary SOC assignments

– Programming required if database does not allow automated output by
secondary SOC
– Benefits - more comprehensive view of medically related events
– Limitations - display by primary and secondary SOC could lead to
double counting
• Grouping terms (HLGT/HLT)
• SMQ
• Customized search
– Modified SMQ
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How Many Cases of

Autoimmune Diseases?
Adverse Event (MedDRA v27.0) No. of cases

SOC Blood and lymphatic system disorders

PT Anaemia 5
PT Autoimmune neutropenia 5
PT Evans syndrome 1
PT Platelet anisocytosis 1
PT Platelet toxicity 2
SOC Cardiac disorders
PT Autoimmune myocarditis 4
PT Myocardial infarction 1
PT Myocarditis 2

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How Many Cases of

Autoimmune Diseases? (cont)

Adverse Event (MedDRA v27.0) No. of cases

SOC Endocrine disorders

PT Polyglandular autoimmune syndrome type I 2
PT Thyroid disorder 1
SOC Eye disorders
PT Birdshot chorioretinopathy 2
PT Autoimmune uveitis 3
SOC Hepatobiliary disorders
PT Primary biliary cholangitis 3
PT Hepatitis toxic 1
PT Hepatocellular injury 1

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How Many Cases of

Autoimmune Diseases? (cont)
Adverse Event (MedDRA v27.0) No. of cases

SOC Immune system disorders

PT Autoimmune disorder 4
SOC Musculoskeletal and connective tissue disorders
PT Arthritis 1
PT Muscular weakness 2
PT Polymyalgia rheumatica 1
PT Rheumatoid arthritis 3
SOC Skin and subcutaneous tissue disorders
PT Alopecia 1
PT Skin haemorrhage 1
PT Vitiligo 2

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MSSO’s MedDRA Browsers

Title 04

MedDRA Desktop Browser (MDB)

Download MDB and release files from MedDRA website
Mobile MedDRA
Browser
MedDRA Web-Based Browser (WBB) https://mmb.meddra.org
https://tools.meddra.org/wbb/
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MSSO’s MedDRA
Browsers (cont)

• Features
– Each require MedDRA ID and password
– View/search MedDRA and SMQs
– Support for all MedDRA languages
– Language specific interface
– Ability to export search results and
Research Bin to local file system
(MDB and WBB only)

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MDB and WBB Special

Features

• Preview upcoming (supplemental)

changes in next release*
*Supplemental view not available on MDB

• View primary and secondary link information

• Upload terms to run against SMQs
• Advanced search options (e.g., NOT, OR)

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Secondary SOC Analysis

Example
Primary SOC

Blood and lymphatic

system disorders

• In my dataset,
which terms Cardiac disorders

are Endocrine disorders

autoimmune Eye disorders

disorders? Hepatobiliary disorders

Immune system disorders

Musculoskeletal and
connective tissue disorders

Skin and subcutaneous

tissue disorders

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Secondary SOC
Information
Optional Secondary SOC hierarchy
• My system only shows the
primary SOC hierarchy.
How do I view secondary
SOC links for a set of
terms?
• Option 1: Export search
results
– Example: search for
“headache”
– Export with primary and
secondary SOC hierarchies
(default setting)

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Secondary SOC
Information (cont)
Optional Secondary SOC hierarchy

• Option 2: Use the Research Bin

– Add terms to Research Bin
– Export with primary and secondary
SOC hierarchies

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Secondary SOC
Information (cont)
Hierarchy Analysis feature

• Option 3: Hierarchy
Analysis feature
– Upload terms in
spreadsheet
– Export with primary
and secondary SOC
hierarchies
– No need for
programming

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Secondary SOC Analysis

Example (cont)
• Output sorted by HLGT – there are 11 autoimmune disorders
Row IDTerm Code LevelHLT HLGT SOC Primary
SOC
1 Anaemia 10002034 PT Anaemias NEC Anaemias nonhaemolytic and Blood
marrowanddepression
lymphatic system disorders Y
7 Myocardial infarction Arteriosclerosis, stenosis, vascular
10028596 PT Coronary necrosis and vascular insufficiency insufficiency
Vascular disorders and necrosis N
2 Autoimmune neutropenia 10055128 PT Blood autoimmune disorders Autoimmune disorders Immune system disorders N
3 Evans syndrome 10053873 PT Blood autoimmune disorders Autoimmune disorders Immune system disorders N
6 Autoimmune myocarditis 10064539 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders N
9 Polyglandular autoimmune syndrome type I
10036072 PT Endocrine autoimmune disorders Autoimmune disorders Immune system disorders N
11 Birdshot chorioretinopathy 10072959 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders N
12 Autoimmune uveitis 10075690 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders N
13 Primary biliary cholangitis 10080429 PT Hepatic autoimmune disorders Autoimmune disorders Immune system disorders N
16 Autoimmune disorder 10061664 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders Y
19 Polymyalgia rheumatica 10036099 PT Muscular autoimmune disorders Autoimmune disorders Immune system disorders N
20 Rheumatoid arthritis 10039073 PT Rheumatoid arthritis and associatedAutoimmune
conditions disorders Immune system disorders N
23 Vitiligo 10047642 PT Skin autoimmune disorders NEC Autoimmune disorders Immune system disorders N
19 Polymyalgia rheumatica 10036099 PT Connective tissue disorders NEC Connective tissue disorders (excl congenital) and connective tissue disorders
Musculoskeletal Y
7 Myocardial infarction 10028596 PT Ischaemic coronary artery disordersCoronary artery disorders Cardiac disorders Y
9 Polyglandular autoimmune syndrome type I
10036072 PT Polyglandular endocrine disordersEndocrine and glandular disorders NEC
Endocrine disorders Y
5 Platelet toxicity 10059440 PT Poisoning and toxicity Exposures, chemical injuries and poisoning
Injury, poisoning and procedural complications
N
14 Hepatitis toxic 10019795 PT Poisoning and toxicity Exposures, chemical injuries and poisoning
Injury, poisoning and procedural complications
N
3 Evans syndrome 10053873 PT Anaemias haemolytic immune Haemolyses and related conditions
Blood and lymphatic system disorders Y
13 Primary biliary cholangitis 10080429 PT Hepatic fibrosis and cirrhosis Hepatic and hepatobiliary disorders
Hepatobiliary disorders Y

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Secondary SOC Analysis and

Use of a Grouping Term

Adverse Event (MedDRA v27.0) No. of cases

SOC Immune system disorders
HLGT Autoimmune disorders 30
PT Autoimmune disorder 4
PT Autoimmune myocarditis 4
PT Autoimmune neutropenia 5
PT Primary biliary cholangitis 3
PT Birdshot chorioretinopathy 2
PT Evans syndrome 1
PT Polyglandular autoimmune syndrome type I 2
PT Polymyalgia rheumatica 1
PT Rheumatoid arthritis 3
PT Autoimmune uveitis 3
PT Vitiligo 2
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Developing Queries Using

MedDRA

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What is a Query?

Clinical Trial Database Query

Safety Database
SMQ
PT
LLT
Case LLT
“Hit”
LLT 1 LLT1
LLT 2
LLT 3 PT
LLT
LLT
LLT

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General Tips for Building

Queries with MedDRA
Pre-Work

• Define the condition

• Develop inclusion/exclusion criteria

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General Tips for Building

Queries with MedDRA
Pre-Work

Build Query
• Use grouping terms where applicable
• Search “non multi-axial” and “other/support” SOCs
• Search a term’s “neighbors”, including secondary
locations
• Avoid using LLTs (Exception: species information at LLT
level in SOC Infections and infestations)

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General Tips for Building

Queries with MedDRA
Pre-Work

Build Query

Store & Maintain

• Store for future use

• Review for impact of new MedDRA versions

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Example –
Cardiac Arrhythmias

• Obvious starting point…

HLGT Cardiac arrhythmias “Top-down” search

• Also, use “Arrhythmia” terms as starting point

of “Bottom-up” search

• What about non-multi-axial SOCs?

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Example –
Cardiac Arrhythmias (cont)

• SOC Investigations
–PTs subordinate to HLT ECG investigations and
HLT Heart rate and pulse investigations should be
reviewed
• Example: PT Heart rate irregular

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Example –
Cardiac Arrhythmias (cont)
• SOC Surgical and medical procedures

Important to review:
–PTs subordinate to HLT Cardiac device
therapeutic procedures*
• Example: PT Implantable defibrillator insertion

–PTs subordinate to HLT Cardiac therapeutic

procedures NEC*
• Example: PT Cardioversion

*Note: Pacemaker and other cardiac therapeutic procedure terms were not
included in SMQ Cardiac arrhythmias
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Example –
Cardiac Arrhythmias (cont)
• Because arrhythmias may produce various signs
and symptoms, you may wish to review PTs
subordinate to the following HLTs:
– HLT Disturbances in consciousness NEC
– HLT Neurological signs and symptoms NEC
– HLT Cardiac disorders NEC
– HLT Cardiac signs and symptoms NEC
– HLT Dyspnoeas

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Example –
Cardiac Arrhythmias (cont)

• Lastly…
–PTs subordinate to HLT Death and sudden death
(under SOC General disorders and administration
site conditions) should be reviewed
• Example: PT Cardiac death

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Cardiac Arrhythmias –
Identifying Cases
Patient Patient Events (PTs) Primary SOC Case of interest?
ID MedDRA v23.0
01 Nausea Unlikely
Vomiting
02 Sudden death General disorders and administration site conditions Potential case. Needs review.

03 Electrocardiogram abnormal Investigations Potential case. Needs review.

Dyspnoea Respiratory, thoracic and mediastinal disorders
Cardio-respiratory arrest Cardiac disorders
04 Breast cancer Unlikely
Postmenopause
05 Syncope Nervous system disorders Potential case. Needs review.
Palpitations Cardiac disorders
06 Pacemaker generated General disorders and administration site conditions Potential case. Needs review.
arrhythmia
07 Atrial fibrillation Cardiac disorders Potential case. Needs review.
Cardioversion Surgical and medical procedures
08 Long QT syndrome congenital Congenital, familial and genetic disorders Potential case. Needs review.

09 Cerebrovascular accident Unlikely

Prostate cancer
10 Cardiac assistance device user Social circumstances Potential case. Needs review

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Search Demonstration

Topic: Cardiac failure

• Build a query with a set of PTs relevant to this
condition
• Consider:
– Diagnosis terms
– Signs and symptoms
– Investigations
– Surgical and medical procedures
– Other….
• Can you identify cases of interest in a dataset?
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Use Poll Everywhere to Get PT

Suggestions from Attendees
(Optional)

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Developing Queries –
Lessons Learned

• MedDRA is a potentially powerful tool for data

retrieval, BUT it requires:
– Solid medical knowledge
– Solid MedDRA knowledge

• Size and complexity of MedDRA overcome lack of

specificity of other terminologies, but may require a
more “creative” approach to data retrieval
• WELL WORTH THE EFFORT to develop, share, and
store in-house queries

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Summary

 Discussed topics in the MedDRA Data Retrieval and

Presentation Points to Consider document
 Discussed applications of MedDRA in data retrieval,
presentation, and analysis
 Discussed and demonstrated the use of MedDRA for
developing queries

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MSSO Contacts
• Website
– www.meddra.org
• Email
– [email protected]
• Frequently Asked Questions
– www.meddra.org/faq
• MedDRA Browsers
– https://www.meddra.org/meddra-desktop-browsers
(Desktop Browser)
– https://tools.meddra.org/wbb/ (Web-Based
Browser)
– https://mmb.meddra.org (Mobile Browser)

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MSSO Contacts (cont)

• Change Request Submission

–https://www.meddra.org/how-to-use/change-
requests
• Training Schedule
–https://www.meddra.org/training/schedule
• MedDRA Support Documentation
– https://www.meddra.org/how-to-use/support-
documentation

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Question and Answer Session

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