ADaM OCCDS v1.0

ADaM Structure for Occurrence Data
(OCCDS)
Version 1.0
Prepared by the
CDISC Analysis Data Model Team
Notes to Readers
This Analysis model uses the principles, structures and standards described in the CDISC Analysis Data Model
Version 2.1 and Implementation Guide v1.1 documents.
Revision History
Date Version Summary of Changes

2016-02-12 1.0 Released version reflecting all changes
identified during finalization of referenced
document ADaMIG v1.1.
2015-06-01 1.0 Provisional release reflecting all changes and
corrections identified during comment period.
2014-03-25 1.0 Draft Draft version released for public comment
See Appendix C for Representations and Warranties, Limitations of Liability, and Disclaimers.
CDISC ADaM Occurrence Data Structure (OCCDS) (Version 1.0)
CONTENTS
1 INTRODUCTION ................................................................................................................. 4
1.1 PURPOSE................................................................................................................................................................4
1.2 POINTS TO CONSIDER WHEN INTERPRETING THIS DOCUMENT ..............................................................................5
1.3 CONVENTIONS USED IN THIS DOCUMENT ..............................................................................................................6
2 DATA ANALYSIS AND CODING...................................................................................... 6

2.1 STATISTICAL ANALYSIS ........................................................................................................................................6
2.2 DICTIONARY CODING ............................................................................................................................................7
2.2.1 Recoding of Occurrence Data ................................................................................................................7
2.3 ADVERSE EVENTS .................................................................................................................................................7
2.4 CONCOMITANT MEDICATIONS DATA ....................................................................................................................8
2.5 PRE-SPECIFIED DATA.............................................................................................................................................8
2.6 COMBINING SPONTANEOUS AND PRE-SPECIFIED OCCURRENCES ...........................................................................8
2.7 OTHER DATA .........................................................................................................................................................8
3 ADAM METADATA ............................................................................................................ 9

3.1 DATASET METADATA ............................................................................................................................................9
3.2 ADAM VARIABLES AND VARIABLE METADATA ...................................................................................................9
3.2.1 ADSL Variables ................................................................................................................................... 10
3.2.2 Identifier Variables ............................................................................................................................... 10
3.2.3 Dictionary Coding and Categorization Variables ................................................................................. 10
3.2.4 Timing Variables .................................................................................................................................. 13
3.2.5 Indicator Variables ............................................................................................................................... 15
3.2.6 Occurrence Flag Variables ................................................................................................................... 17
3.2.7 Treatment/Dose Variables .................................................................................................................... 18
3.2.8 Descriptive Variables ........................................................................................................................... 18
3.2.9 Standardized MedDRA Query Variables ............................................................................................. 19
3.2.10 Original or Prior Coding Variables ...................................................................................................... 20
3.3 OTHER METADATA.............................................................................................................................................. 21
4 EXAMPLE 1: ANALYSIS OF TREATMENT EMERGENT ADVERSE EVENT ..... 22

4.1 ANALYSIS DISPLAY EXAMPLE LAYOUT .............................................................................................................. 22
4.2 SAMPLE ADAM VARIABLE METADATA .............................................................................................................. 23
4.3 SAMPLE ADAM DATA......................................................................................................................................... 25
5 EXAMPLE 2: ANALYSIS OF HEMORRHAGES (SMQ) AMONG TREATMENT

EMERGENT ADVERSE EVENTS BY SEX ........................................................................... 27
5.1 ANALYSIS DISPLAY EXAMPLE LAYOUTS ............................................................................................................. 27
5.3 SAMPLE ADAM DATA......................................................................................................................................... 30
6 EXAMPLE 3: ANALYSIS OF PERIPHERAL SENSORY NEUROPATHY (PSN)

ADVERSE EVENTS BY SEVERITY AND CUMULATIVE DOSE EXPOSURE ............. 31
6.3 SAMPLE ADAM DATA......................................................................................................................................... 32
7 EXAMPLE 4: ANALYSIS OF TREATMENT EMERGENT ADVERSE EVENTS IN

A CROSS-OVER INTERACTION STUDY ............................................................................ 33
© 2016 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2
Final February 12, 2016
7.3 SAMPLE ADAM DATA......................................................................................................................................... 35
8 EXAMPLE 5: MEDDRA SECONDARY PATH ............................................................. 37

8.1 ANALYSIS DISPLAY EXAMPLE ............................................................................................................................. 38
8.2 SAMPLE SDTM AE DATA ................................................................................................................................... 38
8.3 SAMPLE ADAM DATA......................................................................................................................................... 39
9 EXAMPLE 6: ANALYSIS OF CONCOMITANT MEDICATIONS............................. 40

9.3 SAMPLE ADAM DATA......................................................................................................................................... 42
10 EXAMPLE 7: ANALYSIS OF MEDICAL HISTORY MAPPED TO MEDDRA ....... 44

10.3 SAMPLE ADAM DATA......................................................................................................................................... 46
11 EXAMPLE 8: ANALYSIS OF MEDICAL HISTORY PRE-SPECIFIED EVENTS... 47

11.3 SAMPLE ADAM DATA......................................................................................................................................... 49
APPENDICES ............................................................................................................................. 50
APPENDIX A: REFERENCES........................................................................................................................................... 50
APPENDIX B: REVISION HISTORY ................................................................................................................................. 51
APPENDIX C: REPRESENTATIONS AND WARRANTIES, LIMITATIONS OF LIABILITY, AND DISCLAIMERS........................ 52
1 Introduction
1.1 Purpose
The statistical analysis data structure presented in this document describes the general data structure and content
typically found in occurrence analysis. Occurrence analysis is the counting of subjects with a given record or term,
and often includes a structured hierarchy of dictionary coding categories. Examples of data that fit into this structure
include those used for typical analysis of Adverse Events, Concomitant Medications, and Medical History. The
structure is based on the ADaM Analysis Data Model V2.1 [1] and the ADaM Analysis Data Model Implementation
Guide (ADaMIG) V1.1 [2].
This document is based on the document titled “Analysis Data Model (ADaM) Data Structure for Adverse Event
Analysis” released by the CDISC ADaM team on May 10, 2012. It replaces this earlier document, making it more
generic and applicable to analysis of more than just adverse event data.
The table shows a summary of differences between the two documents:
Table 1.1.1: Differences between Data Structures

Data Structure for Data Structure for
Adverse Events Analysis Occurrence Data
Applications Only adverse events Adverse events plus other types of data
ADaM version ADaM v 2.1, ADaMIG v1.0 ADaM v 2.1, ADaMIG v1.1
SDTM version SDTM v1.2, SDTMIG v3.1.2 SDTM v 1.4, SDTMIG v3.2
Dataset metadata class ADAE OCCURRENCE DATA STRUCTURE
ANLzzFL label “Analysis Record Flag zz” “Analysis Flag zz”
AOCCFL label “1st Occurrence of Any AE Flag” “1st Occurrence within Subject Flag”
Study Drug Dose at Variable name “DOSEAEON” and label Variable name “DOSEON” and label
Onset “Study Drug at AE Onset” “Treatment Dose at Record Start”
Separate variables named “DOSAEONU” Variable name “DOSEU” and label
Treatment Dose Units
and “DOSECUMU” “Treatment Dose Units”
Cumulative Actual Variable name “DOSECUM” and label Variable name “DOSCUMA” and label
Treatment Dose “Cumulative Study Drug Dose” “Cumulative Actual Treatment Dose”
Original or Prior Use of “y” suffix to represent prior
Use of “w” suffix to represent prior version
Coding Variables version
As presented in the ADaMIG, many analysis methods can be performed using the ADaM Basic Data Structure
(BDS) including Parameter (PARAM) and Analysis Value (AVAL). However, data analyzed as described above do
not fit well into the BDS structure and are more appropriately analyzed using an SDTM structure with added
analysis variables. Specifically, the data and analysis described in this document must meet these criteria:
• There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or
more records for each occurrence assessment.
• A dictionary is often used for coding the occurrence and typically includes a well-structured hierarchy of
categories and terminology. Re-mapping this hierarchy to BDS variables PARAM and generic *CAT
variables would lose the structure and meaning of the dictionary. Per the Study Data Tabulation Model
Implementation Guide (SDTMIG) V3.2 [3], a dictionary is expected for Adverse Events and Concomitant
Medications, and recommended for Medical History. Although not as common, Clinical Events,
Procedures, and Substance Use may also be coded. (Data for a particular study that could have been coded
but wasn’t should use this structure because analysis results are similar, and this will allow analysis
programming to work the same way – for example, Medical History data might be coded in one study, not
coded in another, yet the analysis tables look very similar.)
• The data content is typically not modified for analysis purposes. In other words, there is no need for
analysis versions of the variables that hold the dictionary hierarchy or category terms.
This does not mean that all categorical data are appropriate for OCCDS. More standard categorical data that would
never be mapped to a hierarchical dictionary, such as questionnaire responses, fit nicely in BDS and should not use
OCCDS.
Typically, findings data fit nicely into BDS, while events and interventions fit nicely into OCCDS. However, this is
not always the case: Exposure data, from an interventions SDTM structure, is quite often analyzed in BDS because
that analysis isn’t simply counting records, though there could be an OCCDS intermediate dataset used to help
derive those BDS summary parameters. In all cases, it’s the combination of input data and analysis needs that
determines the dataset structure required.
The structure presented in this document is built on the nomenclature of the SDTMIG V3.2 [3] standard for collected
data, and adds attributes, variables, and data structures required for statistical analyses. The primary source domain
for the structure is the SDTM domain plus the corresponding Supplemental Qualifier dataset. Many additional
variables are added from Subject-Level Analysis Dataset (ADSL).
In this document, the analysis datasets described are required when SDTM data aren't sufficient to support all
analyses. Whether an analysis dataset is needed is left up to the producer (see ADaM Analysis Data Model V2.1
Section 4.1.1). If an analysis dataset is needed, and it meets the criteria listed above, it should use OCCDS.
The dataset and variable naming conventions and the dataset structure described in this document should be
followed.
The structure for the occurrence analysis dataset is usually one record per each record in the corresponding SDTM
domain. Examples of when the number of records in the analysis dataset would not match the number in SDTM
include:
• SDTM data contain screen failures but screen failures are not analyzed. In this case, the screen failure
records are not needed in the analysis dataset.
• The topic, such as an adverse event or concomitant medication, spans several treatment periods and needs
to be counted in each. Based on the analysis need, a separate row might be required for each treatment
period spanned and analyzed.
• An adverse event needs to be analyzed along multiple coding paths. In this case, a row would be needed for
each coding path analyzed. An alternate solution, if multiple coding paths are not needed together, would
be to put records for each coding path into a separate analysis dataset.
This doesn’t exclude a producer from creating additional datasets for other analyses, or even using a different
structure if needed for analysis (e.g. time-to-event of adverse events of special interest).
1.2 Points to Consider When Interpreting this Document

In reviewing the metadata and examples in this document, some of the points to consider are:
• Ordering of variables: Within this document, no specific ordering of variables within the illustrated
datasets is applied. The ADaM v2.1 [1] states that ideally the ordering of the variables in the analysis dataset
follows a logical ordering (not simply alphabetic). The ADaM v2.1 [1] does not provide a specific
recommendation for the ordering of the variables. Within this document, the author of each example
applied their own logical ordering. Though there is not an across-example consistency of ordering of
variables, within an example the ordering of the variables within the illustrated analysis dataset matches the
order of the variables as presented in the associated metadata.
• Identification of source dataset: When identifying the source dataset for a variable, the immediate
predecessor is used, as described in the ADaM v2.1 [1]. For example, in ADSL the source is identified as
DM.SUBJID in the analysis variable metadata. When SUBJID is used in the occurrence analysis dataset,
the source is identified as ADSL.SUBJID.
• Analysis-ready: The occurrence analysis dataset should be “analysis-ready,” meaning it should contain all
of the variables needed for the specific analysis, so that the analysis can be replicated by performing the
actual statistical test without first having to manipulate data. Analysis-ready does not mean that a formatted
display can be generated in a single statistical procedure. For typical occurrence analyses, unique subject
counts are derived by running a standard statistical procedure (e.g., SAS PROC, S-PLUS function, etc.) on
the occurrence analysis dataset, while denominator counts can be derived from ADSL.
• Examples are for illustration only: Note that the examples in this document are only intended as
illustrations and should not be viewed as a statement of the standards themselves. In addition, the examples
are intended to illustrate content and not appearance; it is understood that there are many different ways
that data can be displayed. This document does not cover display formats.
• Display of metadata for illustration of content only: Though the metadata elements have been defined in
the ADaM v2.1 [1], how the metadata are displayed is a function of the mechanism used to display the
content. The presentation formats used in this document are for the purposes of illustration of content only,
and are not intended to imply any type of display standard or requirement. Additionally, the metadata
examples just include the metadata necessary to understand the respective example datasets. Refer to
Define-XML v2.0 [11] for additional information (e.g., variable length and origin) required when building a
valid define.xml file according to the Define-XML v2.0 standard.
• Analysis results metadata: Analysis results metadata have not been included for any examples in this
document. As stated in the ADaM v2.1 [1], analysis results metadata are not required. However, best
practice is that they be provided to assist the consumer by identifying the critical analyses, providing links
between results, documentation, and datasets, and documenting the analyses performed.
• Examples not meant to be all inclusive regarding variables: The examples describe some of the key
variables and records that would be included in the dataset. They are not intended to illustrate every
possible variable that might be included in the analysis dataset; for example core variables required for
subgroup analyses are not included in all illustrations.
• Source/Derivation Column: The algorithms provided in the Source/Derivation column are for illustration
purposes only and are not intended to imply universally accepted definitions or derivations of variables.
Algorithms are producer-defined and dependent on trial and analysis design.
• No endorsement of vendors or products: As with other ADaM documents, references to specific vendor
products are examples only and therefore should not be interpreted as an endorsement of these vendors or
products.
1.3 Conventions Used in this Document

Throughout this document the terms “producer” and “consumer” are used to refer to the
originator/sender/owner/sponsor of the data and the user/reviewer/recipient of the data, respectively. These terms are
used to simplify the document, and are not intended to imply that these examples only apply to analysis datasets in
the context of electronic submissions to regulatory agencies.
2 Data Analysis and Coding

2.1 Statistical Analysis
The most frequently used method for the comparison between treatment groups of data in this structure is the
summarization of the number of subjects with at least one occurrence of a term. These counts and related
percentages are presented at different levels of the dictionary hierarchy, when the hierarchy exists. The denominator
used for the calculation of the percentages is often determined by a population flag, such as the total number of
subjects at risk or number of subjects exposed to treatment. Note that some subjects in the population may not have
any records, and therefore these subjects would not be represented in the SDTM domain nor the corresponding
OCCDS analysis dataset. Thus, the denominators usually need to be obtained from ADSL (subject level analysis
dataset) rather than directly from the occurrence analysis dataset.
This ADaM model primarily discusses the creation of an analysis dataset that is needed for the presentation of
frequencies and percentages. However, the analysis datasets presented here could be used to construct more in-depth
analysis dataset, even in a different structure. For time-to-event analyses, see the ADaM Basic Data Structure for
Time to Event Analyses appendix.
2.2 Dictionary Coding

Data are often collected in textual or ‘verbatim’ content, a short description of an event or intervention generally
written in free text on the case report form. Verbatim content is then processed through a coding dictionary so that
similar verbatim content is grouped together by classifying them into a hierarchy of medical granularity.
Medical Dictionary for Regulatory Activities (MedDRA) [4] has become widely recognized as a global standard for
the coding of adverse events. Examples of other coding dictionaries include WHO Adverse Reaction Terminology
(WHO-ART) [5] and International Classification of Disease (ICD) [6], and Coding Symbols for a Thesaurus of
Adverse Reaction Terms (COSTART) [7] which was replaced by MedDRA but can still be found in older studies.
The coding dictionary is characterized by classifying each verbatim into a hierarchy of medical granularity. For
example, if the verbatim content recorded was ‘stomach virus’, the COSTART coding hierarchy would place this
event in the ‘Body as a Whole’ body system, in the ‘General’ subcategory for this body system, and with the
preferred term of ‘Flu Syndrome’. Using MedDRA V12.0, this verbatim content would result in a System Organ
Class (SOC) of ‘Infections and infestations’ and a preferred term (PT) of ‘Gastroenteritis viral’.
When using coding dictionaries, it is recommended that coding rules and guidelines be developed by the producer
prior to the classification of terminology. The process of coding verbatim terms with a dictionary is outside the
scope of this document. The objective of coding guidelines is to promote medical accuracy and consistency when
using the controlled vocabulary of the dictionary. This consistency will support a variety of downstream analysis
needs, such as when events need to be recoded to integrate data from two or more clinical studies.
2.2.1 Recoding of Occurrence Data

In some situations, multiple study reports are created for a single study. For example, an initial study report may be
created at the time of the primary analysis for the primary efficacy endpoint. If subjects are followed for safety, a
second report may be created years later so that long term safety data can be incorporated. At this time, there may be
a desire to update the coding dictionary so that all content is coded using the most recent version of a dictionary. In
this situation, a recommendation is to provide the original coded terms along with the new coded terms so that the
implications of the recoding can be more easily investigated.
It should be noted that a more common scenario involving the recoding of occurrence data is when data are recoded
for an integrated analysis and submitted to a regulatory agency for marketing approval. However, neither the current
version of the ADAMIG nor this document fully covers integration of multiple studies. The ADaM team is
developing a document to address integration of multiple studies. Some of the suggestions included here for
handling multiple dictionaries may be revised after this Integration document is released.
2.3 Adverse Events

The safety evaluation of a clinical trial includes the analysis of adverse events, and that analysis is typically done
using this data structure. The definition of an adverse event, as presented in International Conference of
Harmonization (ICH) E2A [8] guidelines, is:
Any untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have to have a causal relationship with this
treatment.
Important attributes include the level of severity of the AE (Mild, Moderate, or Severe), whether the AE is
considered to be related to the study product (Yes or No), and whether the AE is considered serious (Yes or No). Of
particular importance in the analysis of AEs is the definition of ‘treatment emergent’. The ICH E9 guidance [9]
document defines treatment emergent as an event that emerges during treatment having been absent pre-treatment,
or worsens relative to the pre-treatment state. Operationally, classifying AEs as treatment emergent will utilize, in
part, the start or worsening date of the AE relating to the trial or treatment start. Other important attributes of AEs
include the action taken in response to the event and whether the event led to permanent discontinuation of the
investigational product.
2.4 Concomitant Medications Data

Concomitant medications data can be coded to a hierarchy such as WHO Drug and summarized by medication
and/or ingredient within class.
2.5 Pre-specified Data

In some cases, data can be gathered on a case report form that contains a pre-specified category and a checkbox to
indicate whether or not the subject had this event, condition, or treatment. This information is stored in these
variables as described in the SDTMIG. --PRESP is used to indicate that the term is a pre-specified one, and --
OCCUR is either Y or N to indicate whether the subject did or did not have the event, condition, or treatment. --
TERM or --TRT will have a known and finite set of values, so these values may be adequate to use as a
summarization category. Often these pre-specified terms are grouped into categories at collection using the --CAT
and --SCAT variables, creating additional levels of summarization categories. In this situation, data are analyzed by
variables such as --TERM, --TRT, --CAT and --SCAT, and dictionary coding might not be necessary. For example,
medical history and clinical events data are often captured in this way.
Note that this pre-specified data option does not work well for Adverse Events because the Study Data Tabulation
Model Implementation Guide (SDTMIG) V3.2 [3] does not permit the use of variable AEOCCUR. In other words, all
records in SDTM AE must correspond to an actual occurrence of the event.
2.6 Combining Spontaneous and Pre-specified Occurrences

It is technically feasible to apply the same coding dictionary to both collected and pre-specified data and combine
these data for analysis. Whether or not to do so is a statistical judgment that should be carefully considered and
described in programming specifications. A pre-specified question on a case report form makes it more likely to
receive data, and would therefore increase the frequency in a summary. In deciding whether to pool pre-specified
and spontaneous data, the statistician should consider the way data were gathered and weigh the possibility of over-
reporting pre-specified data. The statistician should also carefully consider and describe the correct denominator for
percentages.
If data are pooled in this way, take care that non-occurring data (--OCCUR=N) are properly excluded from the
analysis.
2.7 Other Data

Other similar data, with or without coding hierarchy, can be summarized similarly. An example of summarizing
without a coding hierarchy can be seen in the example in Section 11.
Some examples of other data that can also be summarized using OCCDS include:
• Clinical Events, when collected by category and not mapped to a dictionary, but summarized in a similar
way as Adverse Events.
• Protocol violations, when summarized by counting subjects with violations within each category.
• Laboratory data containing National Cancer Institute Common Toxicity Criteria (NCI-CTC) [10] information
that has been coded with MedDRA and summarized as laboratory events. When these events are
summarized like adverse events, an extension of the adverse event examples that are shown in this
document can be used.
In all cases, OCCDS should be used when a summary of the hierarchy is done, counting the number of subjects at
each level of the hierarchy. Alternately, BDS should be used for counting when there isn’t a hierarchy, when the
terms are counted rather than the subjects, and when variables such as AVAL and PARAM are appropriate to
include.
3 ADaM Metadata
As described in the ADaM Analysis Data Model V2.1 [1], variables that are copied from SDTM must have the same variable name, label, values, and meaning as
in SDTM. Because the Occurrence Data Structure (OCCDS) can be used for adverse events, concomitant medications, and other occurrence data, metadata
shown in this section reference different SDTM domains. For clarity, the following conventions are used:
• When referring to the 2-letter prefix in variable names, the standard convention is to use “--”, as described in the Study Data Tabulation Model v1.4 [3].
• The “--” convention was intended for variable names, not domain names, and “--” is difficult to read in the documentation for SDTM domain names.
This document uses the convention of “XX” to represent a domain name, as was done in the Analysis Data Model (ADaM) Examples in Commonly
Used Statistical Analysis Methods appendix document.
• Variable labels that differ depending on SDTM domain are shown with the SDTM observation class label followed by an asterisk (*), referencing a note
at the end of the table.
Take care when creating actual metadata to replace “--”, “XX”, and generic variable labels with the actual 2-letter domain code and label from SDTM.
3.1 Dataset Metadata

Typically, the following Analysis Dataset Metadata is specified as follows:
Table 3.1.1 Example of ADaM OCCDS Dataset Metadata*,

Dataset Dataset Dataset Key Variables of
Dataset Structure Class of Dataset Documentation
Name Description Location Dataset
ADXXXXXX <Dataset label> adxxxxxx.xpt one record per record in SDTM domain List variables, such OCCURRENCE DATA Example: Dictionary used
(optional: per coding path, per Analysis Period as USUBJID, STRUCTURE is MedDRA V11.1
and/or Phase)† --SEQ
3.2 ADaM Variables and Variable Metadata

As stated earlier, OCCDS is different from BDS. There is no PARAM nor AVAL, for example. However, some of the variables described for BDS in the ADaM
Implementation Guide version 1.1 [2] can be used in OCCDS, as shown below.
The more standardized variables commonly occurring in an ADaM OCCDS are described here in tabular format. In general, include all variables from the SDTM
dataset and corresponding supplemental qualifiers that are needed for analysis or traceability. For traceability when copying variables from SUPPQUAL, it is
recommended to use variable names that exactly match the corresponding SUPPQUAL.QNAM values. Additional study or therapeutic specific variables may be
added as needed but should follow the standard variable naming conventions described in the ADaM Implementation Guide version 1.1 [2]. For example,
variables with the 2-letter SDTM prefix are most commonly those that are copied from the SDTM or transposed SUPPQUAL dataset, or the numeric version of
the SDTM variable, but not analysis versions of SDTM variables. Choose variable names with care to prevent unintended conflicts with standard names.
* The display presentation of the metadata should be determined between the producer and the consumer. The example is only intended to illustrate content and not appearance.
† See discussion near the end of the Introduction section of this document for examples of when the analysis data structure might not be one record per record in SDTM domain
As described in the ADaM Analysis Data Model V2.1 [1], the two rightmost columns of metadata (“Core” and “CDISC Notes”) provide information about the
variables to assist users in preparing their datasets. These columns are not meant to be metadata. The “Core” column, as defined in the ADaM Implementation
Guide version 1.1 [2], describes whether a variable is required (Req), conditionally required (Cond), or permissible (Perm). The “CDISC Notes” column provides
more information about the variable. In addition, the “Type” column is being used to define whether the variable is character (Char) or numeric value (Num).
More specific information will be provided in metadata.
3.2.1 ADSL Variables

Merge any ADSL variables needed for analysis or reference.
Be aware that only subjects with an SDTM record would have an analysis record. For this reason, it is recommended that population indicators and denominator
counts for percentages be derived from ADSL and not from the occurrence analysis dataset.
3.2.2 Identifier Variables

Include the identifier variables from SDTM:
Table 3.2.2.1 OCCDS Identifier Variables

Code List /
Variable Name Variable Label Type Core CDISC Notes
Controlled Terms
STUDYID Study Identifier Char Req XX.STUDYID
USUBJID Unique Subject Identifier Char Req XX.USUBJID
SUBJID Subject Identifier for the Study Char Perm ADSL.SUBJID
SITEID Study Site Identifier Char Perm ADSL.SITEID
--SEQ Sequence Number Num Req* XX.--SEQ
This would be copied from the SDTM domain XX. This may be missing for derived rows.
Required for traceability back to SDTM.
*Note that the only sequence number option shown is --SEQ, because it is unlikely that multiple SDTM domains would be used as input to a single OCCDS dataset.
3.2.3 Dictionary Coding and Categorization Variables

Dictionary coding and categorization variables provided in SDTM should be included as needed for analysis, review, or traceability. Variables shown below are
the common coding variables. If other coding variables are included in SDTM and pertinent for analysis, these should be included in ADaM using a similar
naming convention as shown below. For any public versioned dictionary, the metadata for each coding variable should include both the name and version of the
dictionary.
Common Dictionary Coding Variables for MedDRA

MedDRA coding is typically used for AEs and Medical History. Copy to the analysis dataset the needed MedDRA terms and codes from SDTM. It is
recommended but not required that all levels of terms for the primary path in the MedDRA hierarchy [System Organ Class (SOC), High Level Group Term
(HLGT), High Level Term (HLT), Lowest Level Term (LLT), and Preferred Term (PT)] be included, especially in the AE analysis dataset, as these are
frequently useful in further analyses of events.
Table 3.2.3.1 MedDRA Dictionary Coding Variables

Variable Codelist /
Variable Label Type Core CDISC Notes
Name Controlled Terms
--TERM Reported Term* Char Req XX.--TERM
This would be copied from the SDTM domain XX.
--DECOD Dictionary- Char MedDRA Cond XX.--DECOD
Derived Term This would be copied from the SDTM domain XX. It is typically one of the primary variables used in an
analysis and would be brought in from the SDTM domain. Equivalent to the Preferred Term (PT in
MedDRA). As mentioned above, all other SDTM domain variables and supplemental qualifiers needed for
analysis or traceability should also be included. Include the dictionary version in the metadata.
Conditional on whether coded and used for analysis. Required for Adverse Event data.
--BODSYS Body System or Char MedDRA Cond XX.--BODSYS
Organ Class This would be copied from the SDTM domain XX. It is typically one of the primary variables used in an
analysis and would be brought in from the SDTM domain. As mentioned above, all other SDTM domain
variables and supplemental qualifiers needed for analysis or traceability should also be included. Include the
dictionary version in the metadata.
Conditional on whether coded and used for analysis. Required for Adverse Event data.
--BDSYCD Body System or Num MedDRA Perm XX.--BDSYCD
Organ Class This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
Code version in the metadata.
--LLT Lowest Level Char MedDRA Cond XX.-- LLT
Term This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
version in the metadata.
Conditional on whether coded and used for analysis.
--LLTCD Lowest Level Num MedDRA Perm XX.--LLTCD
Term Code This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
--PTCD Preferred Term Num MedDRA Perm XX.--PTCD
Code This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
--HLT High Level Char MedDRA Cond XX.--HLT
Term This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
Conditional on whether used for analysis.
--HLTCD High Level Num MedDRA Perm XX.--HLTCD
Term Code This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
--HLGT High Level Char MedDRA Cond XX.--HLGT
Group Term This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
Conditional on whether used for analysis.
Variable Codelist /
--HLGTCD High Level Num MedDRA Perm XX.--HLGTCD
Group Term This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary
--SOC Primary System Char MedDRA Cond XX.--SOC
Conditional on whether a secondary SOC was used for analysis.
--SOCCD Primary System Num MedDRA Perm XX.--SOCCD
* This variable label differs depending on the SDTM domain. See Study Data Tabulation Model V1.4 and Study Data Tabulation Model Implementation Guide (SDTMIG) V3.2 [3]
for details.
NOTE: MedDRA allows for secondary paths for Lower Level Terms. One may be required to report on secondary paths along with primary paths. Please see
section 8for an example layout for one possible way to handle this analysis need.
Common Dictionary Coding Variables for WHO Drug

WHO Drug coding is typically used for Concomitant Medications. Copy to the analysis dataset the needed WHO Drug terms and codes from SDTM CM and
SUPPCM. The variables shown in this table 3.2.3.2 are intended for a single WHO Drug coding path.
Table 3.2.3.2 WHO Drug Dictionary Coding Variables

Variable Codelist /
CMTRT Reported Name of Drug, Char Req CM.CMTRT
Med, or Therapy
CMDECOD Standardized Medication Char WHO Drug Cond CM.CMDECOD
Name This is typically one of the primary variables used in CM analysis and would be copied from the
SDTM CM domain. Include the dictionary version in the variable metadata.
Conditional on whether coded and used for analysis.
CMCLAS Medication Class Char Perm CM.CMCLAS
Include the dictionary version in the metadata.
CMCLASCD Medication Class Code Char Perm CM.CMCLASCD
Include the dictionary version in the metadata.
ATCy ATC Level y Text Char WHO Drug Cond Corresponds to the ATC Level Text for WHO Drug
Conditional, based on analysis at multiple levels (y)
ATCyCD ATC Level y Code Char WHO Drug Cond Corresponds to the ATC Level Code for WHO Drug
Conditional, based on analysis at multiple levels (y)
Other Categorization Variables

When categories are used for the intended analysis, instead of or in addition to MedDRA or WHO Drug, these generic categorization variables are commonly
used:
Table 3.2.3.3 Other Categorization Variables

Variable Variable Codelist /
Type Core CDISC Notes
Name Label Controlled Terms
--CAT Category* Char Perm XX.--CAT
--SCAT Subcategory* Char Perm XX.--SCAT
ACATy Analysis Char Perm Category used in analysis. May be derived from --CAT and/or --SCAT. Examples include records of special
Category y interest like prohibited medications, concomitant medications taken during an infusion reaction, growth factors,
antimicrobial medications, and other such categories not defined elsewhere or present in SDTM domains.
for details.
3.2.4 Timing Variables

Timing variables are copied from SDTM and derived within ADaM. Included below are the common timing variables. If other timing variables are collected in
SDTM and pertinent for analysis, these should be included in ADaM. Additional timing variables, such as those for analysis period or phase, can be included.
For more details on timing variables, see the BDS structure in the ADaM Implementation Guide version 1.1 [2].
Table 3.2.4.1 Timing Variables

Variable Codelist /
--STDTC Start Date/Time of Char ISO 8601 Perm Copied from XX.--STDTC
Observation* This would be copied from the SDTM domain XX.
ASTDT Analysis Start Date Num Cond Created from converting XX.--STDTC from character ISO8601 format to numeric date format, applying
imputation rules as specified in the SAP or metadata.
Conditional on whether start date is pertinent for study and is populated in SDTM.
ASTTM Analysis Start Num Cond Created from converting XX.--STDTC from character ISO8601 format to numeric time format, applying
Time imputation rules as specified in the SAP or metadata.
Conditional on whether start time is pertinent for study and is populated in SDTM.
ASTDTM Analysis Start Num Cond Created from converting XX.--STDTC from character ISO8601 format to numeric date-time format,
Date/Time applying imputation rules as specified in the SAP or metadata.
Conditional on whether start date-time is pertinent for study and is populated in SDTM.
ASTDTF Analysis Start Date Char (DATEFL) Cond Created during conversion of XX.--STDTC from character to numeric. Imputation flags are described in
Imputation Flag the ADaM Analysis Data Model Implementation Guide (ADaMIG) V1.1 [2] General Timing Variable
Conventions.
Conditional on whether any imputation is done for the start date.
ASTTMF Analysis Start Char (TIMEFL) Cond Created during conversion of XX.--STDTC from character to numeric. Imputation flags are described in
Time Imputation the ADaM Analysis Data Model Implementation Guide (ADaMIG) V1.1 [2] General Timing Variable
Flag Conventions.
Conditional on whether any imputation is done for the start time.
Variable Codelist /
--ENDTC End Date/Time of Char ISO 8601 Cond Copied from XX.--ENDTC
Observation* This would be copied from the SDTM domain XX.
Conditional on whether end date is pertinent for study and is populated in SDTM.
AENDT Analysis End Date Num Cond Created from converting XX.--ENDTC from character ISO8601 format to numeric date format, applying
Conditional on whether end date is pertinent for study and is populated in SDTM.
AENTM Analysis End Time Num Cond Created from converting XX.--ENDTC from character ISO8601 format to numeric time format, applying
Conditional on whether end time is pertinent for study and is populated in SDTM.
AENDTM Analysis End Num Cond Created from converting XX.--ENDTC from character ISO8601 format to numeric date-time format,
Date/Time applying imputation rules as specified in the SAP or metadata.
Conditional on whether end date-time is pertinent for study and is populated in SDTM.
AENDTF Analysis End Date Char (DATEFL) Cond Created during conversion of XX.--ENDTC from character to numeric. Imputation flags are described in
Conventions.
Conditional on whether any imputation is done for the end date.
AENTMF Analysis End Time Char (TIMEFL) Cond Created during conversion of XX.--ENDTC from character to numeric. Imputation flags are described in
Conventions.
Conditional on whether any imputation is done for the end time.
ASTDY Analysis Start Num Cond Example derivation:
Relative Day ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT<
TRTSDT
This variable may instead be copied from --STDY.
Conditional on whether analysis start relative day is pertinent to the study.
--STDY Study Day of Start Num Perm XX.--STDY
of Observation* This would be copied from the SDTM domain XX.
ASTDY may differ from --STDY due to date imputation and the option in ADaM to use a reference date
other than SDTM’s RFSTDTC. Including XX.--STDY in addition to ASTDY adds traceability.
AENDY Analysis End Num Perm Example derivation:
Relative Day AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT <
TRTSDT
This variable may instead be copied from --ENDY.
--ENDY Study Day of End Num Perm XX.--ENDY
of Observation* This would be copied from the SDTM domain XX.
AENDY may differ from --ENDY due to date imputation and the option in ADaM to use a reference date
other than SDTM’s RFSTDTC. Including XX.--ENDY in addition to AENDY adds traceability.
ADURN Analysis Duration Num Perm Derive from ASTDT (or ASTDTM) and AENDT (or AENDTM).
(N)
ADURU Analysis Duration Char (UNIT) Cond Conditional on whether ADURN is included and units are not included in the label of ADURN.
Units
--DUR Duration of XX Char ISO 8601 Perm XX.--DUR
Variable Codelist /
Because --DUR is a collected field and ADURN is derived, the values will often differ. Including XX.--
DUR in addition to ADURN adds traceability.
APERIOD Period Num Perm APERIOD is a record-level timing variable that represents the analysis period within the study associated
with the record for analysis purposes. The value of APERIOD (if populated) must be one of the xx values
found in the ADSL TRTxxP variables. See the ADaM Implementation Guide version 1.1 [2] for more
information on this variable.
APERIODC Period (C) Char Perm Text characterizing to which period the record belongs. One-to-one map to APERIOD.
APHASE Phase Char Perm APHASE is a categorization of timing within a study, for example a higher-level categorization of
APERIOD or an analysis epoch. For example, APHASE could describe spans of time for SCREENING,
ON TREATMENT, and FOLLOW-UP. See the ADaM Implementation Guide version 1.1 [2] for more
information on this variable.
for details.
Code Lists in parenthesis are the names of CDISC Controlled Terminology.
3.2.5 Indicator Variables

Some indicator variables can be copied from SDTM, while others are derived within ADaM. If indicator variables other than those shown here are included in
SDTM and pertinent for analysis, these should be copied to ADaM. If other indicator analysis variables are needed for analysis, these can also be added.
Table 3.2.5.1 SDTM Indicator Variables

Variable Name Variable Label Type Codelist / Controlled Terms Core CDISC Notes
--OCCUR XX Occurrence Char (NY) Cond Copied from XX.--OCCUR
Conditional on whether this content is pertinent for analysis and is populated in SDTM.
--PRESP XX Pre-Specified Char (NY) Cond Copied from XX.--PRESP
Conditional on whether this content is pertinent for analysis and is populated in SDTM.
Code lists in parenthesis are the names of CDISC Controlled Terminology.
Table 3.2.5.2 OCCDS Indicator Variables

ANLzzFL Analysis Char Y Cond The ANLzzFL flag is useful in many circumstances; an example is when there is more than one coding path
Flag zz included for analysis, in which case separate analysis flags could be used to denote primary coding path or the
records used for analysis from each coding path.
See the ADaM Implementation Guide version 1.1 [2] for more information on this flag variable.
This variable is conditional on whether analysis records flags are needed for analysis.
With Adverse Events and Concomitant Medications, typically indicator flags are also assigned based on the timing of the analysis record in relation to the study.
Below are some common indicator flags for these types of data.
Table 3.2.5.3 Adverse Events Indicator Variables

Variable Code List /
TRTEMFL Treatment Char Y Cond Treatment emergent flag as defined for analysis. Variable TRTEMFL is to be used for any analysis of
Emergent treatment-emergent AEs. This variable is conditional on whether the concept of treatment emergent is a key
Analysis Flag feature of the AE analyses.
Example derivation:
If ADSL.TRTSDT≤ASTDT≤ADSL.TRTEDT + x days then TRTEMFL=’Y’
The number x is defined by the producer and often incorporates the known half-life of the drug. It should be
consistent with variable APHASE (described above) if APHASE is also used.
AETRTEM Treatment Char (NY) Perm Treatment emergent flag from SDTM, if available. See the SDTMIG version 3.2 [3] for more information.
Emergent Flag Derivation:
SUPPAE.QVAL where QNAM=’AETRTEM’.
TRTEMFL may differ from AETRTEM due to different definitions, date imputation and other analysis rules.
Including AETRTEM in addition to TRTEMFL will add traceability.
Code lists in parenthesis are the names of CDISC Controlled Terminology.
Table 3.2.5.4 Concomitant Medications Indicator Variables

Variable Variable Code List /
ONTRTFL On Treatment Char Y Cond Character indicator of whether the observation occurred while the subject was on treatment.
Record Flag Example derivation:
If ADSL.TRTSDT <= ASTDT <= ADSL.TRTEDT then ONTRTFL = ‘Y’
This variable is conditional on whether the concept of on-treatment is a feature of the study and used in
analysis.
Table 3.2.5.5 Adverse Events and Concomitant Medications Indicator Variables

PREFL Pre-treatment Char Y Cond Character indicator of whether the observation occurred before the subject started treatment.
Flag Example derivation:
If ASTDT < ADSL.TRTSDT then PREFL=’Y’
This variable is conditional on whether the concept of pre-treatment is a feature of the study and used in
analysis.
FUPFL Follow-up Flag Char Y Cond Character indicator of whether the observation occurred while the subject was on follow-up.
Example derivation:
If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
This variable is conditional on whether the concept of follow-up is a feature of the study and used in analysis.
3.2.6 Occurrence Flag Variables

Occurrence flags can be used to prepare data for analysis. They are typically created by sorting the data in the required order and then flagging the first treatment
emergent record. The use of the word “first” in this section doesn’t necessarily mean chronological, though that is an option. The more common occurrence flags
and a structure for additional flags are shown below:
Table 3.2.6.1 OCCDS Occurrence Flag Variables

Variable Codelist /
AOCCFL 1st Occurrence within Char Y Perm Character indicator for the first occurrence of any event/intervention/finding within the subject.
Subject Flag Example derivation: Sort the data in the required order and flag the first treatment emergent
record for each subject.
AOCCPFL 1st Occurrence of Preferred Char Y Perm Character indicator for the first occurrence of the preferred term within the subject.
Term Flag Example derivation: Sort the data in the required order and flag the first treatment emergent
record for each --DECOD for each subject.
AOCCIFL 1st Max Sev./Int. Char Y Perm Character indicator for the first occurrence of the event/intervention/finding with the maximum
Occurrence Flag severity/intensity within the subject.
Example derivation: Sort the data in the required order and flag the first treatment emergent
record for maximum severity for each subject.
AOCCPIFL 1st Max Sev./Int. Occur Char Y Perm Character indicator for the first occurrence of the maximum severity/intensity within the subject
Within PT Flag and preferred term.
record for maximum severity within preferred term for each subject.
AOCCzzFL 1st Occurrence of …. Char Y Perm Additional flag variables as needed for analysis. Derivation rules for these flags need to be
described in the metadata.
Table 3.2.6.2 MedDRA Occurrence Flag Variables

Variable Codelist /
AOCCSFL 1st Occurrence of SOC Flag Char Y Perm Character indicator for the first occurrence of the system organ class within the subject.
record for each body system for each subject.
AOCCSIFL 1st Max Sev./Int. Occur Char Y Perm Character indicator for the first occurrence of the maximum severity/intensity within the subject
Within SOC Flag and system organ class.
record for maximum severity within body system for each subject.
3.2.7 Treatment/Dose Variables

The treatment variable used for analysis must be included. Typically this would be TRTP, TRTA, TRTxxP, or TRTxxA. See the ADaM Implementation Guide
version 1.1 [2] for more details on these variables. Additional dosing variables may also be included.
Table 3.2.7.1 Treatment/Dose Variables

Codelist /
Variable Name Variable Label Type Core CDISC Notes
Controlled Terms
DOSEON Treatment Dose at Num Perm Dose received at the point in time of the record start date.
Record Start Example derivation:
Obtained from EX.EXDOSE where --STDTC falls between the values of EX.EXSTDTC and
EX.EXENDTC
DOSCUMA Cumulative Actual Num Perm Cumulative actual study drug dosage at the point in time of the record start date.
Treatment Dose
DOSEU Treatment Dose Units Char (UNIT) Cond Conditional on whether DOSEON and/or DOSCUMA are included.
3.2.8 Descriptive Variables

Variables that describe the record are often used in analysis. Include these and any other SDTM variables if used in analysis. If the analysis version of the
variable differs from the version in SDTM, additional variables must be added using the conventions below and described in Section 3.2.
Shown here are some common descriptive variables that are often included in ADAE. Any other SDTM variables should be included as appropriate (e.g.
AEOUT, AESDTH).
Table 3.2.8.1 Adverse Event Descriptive Variables

Variable Codelist /
Variable Label Type Core
Name Controlled Terms CDISC Notes
AESER Serious Event Char (NY) Req AE.AESER
AESEV Severity/Intensity Char (AESEV) Perm AE.AESEV
AESEVN Severity/Intensity (N) Num 1, 2, 3 Perm Code AE.AESEV to numeric
Low intensity should correspond to low value
ASEV Analysis Char * Perm Apply imputation rules for missing severity of adverse events as specified in the SAP or metadata.
Severity/Intensity May change case of text, such as from all uppercase in AESEV to mixed case in ASEV.
ASEVN Analysis Num 1, 2, 3 Perm Code ASEV to numeric
Severity/Intensity (N) Low intensity should correspond to low value
SEVGRy Pooled Severity Group y Char * Perm Pooled grouping of AE Severity for analysis (e.g. mild/moderate or severe).
SEVGRyN Pooled Severity Group y Num * Perm Code SEVGRy to numeric
(N) Low intensity should correspond to low value
AEREL Causality Char * Perm AE.AEREL
AERELN Causality (N) Num * Perm Code AE.AEREL to numeric
Low relation should correspond to low value
Variable Codelist /
AREL Analysis Causality Char * Perm Apply imputation rules for missing causality of study drug as specified in the SAP or metadata.
May change case of text, such as from all uppercase in AEREL to mixed case in AREL.
ARELN Analysis Causality (N) Num * Perm Code AREL to numeric
RELGRy Pooled Causality Group y Char * Perm Pooled grouping of causality of study drug for analysis (e.g. related, Not related).
RELGRyN Pooled Causality Group y Num * Perm Code of RELGRy to numeric
(N) Low relation should correspond to low value
AETOXGR Standard Toxicity Grade Char * Perm AE.AETOXGR
AETOXGRN Standard Toxicity Grade Num * Perm Code AETOXGR to numeric
(N) Low toxicity should correspond to low value
ATOXGR Analysis Toxicity Grade Char * Perm Toxicity grade for analysis. May be based on AETOXGR or an imputed or assigned value. May
change case of text, such as from all uppercase in AETOXGR to mixed case in ATOXGR.
ATOXGRN Analysis Toxicity Grade Num * Perm Code ATOXGR to numeric
TOXGGRy Pooled Toxicity Grade Char * Perm Pooled grouping of toxicity grade for analysis.
Group y
TOXGGRyN Pooled Toxicity Grade y Num * Perm Code of TOXGGRy to numeric
AEACN Action Taken with Study Char (ACN) Perm AE.AEACN
Treatment
* Indicates variable may be subject to producer-defined controlled terminology.
Code Lists in parenthesis are the names of CDISC Controlled Terminology.
Medical History data typically does not contain descriptive variables. If needed for analysis, use variables as shown above for Adverse Events, replacing the
prefix “AE” with “MH”.
Shown here are some common descriptive variables that are often included in ADCM. Any other SDTM variables should be included as appropriate.
Table 3.2.8.2 Concomitant Medications Descriptive Variables

Variable Name Variable Label Type Code List / Controlled Terms Core CDISC Notes
CMSTAT Completion Status Char Perm CM.CMSTAT
CMINDC Indication Char Perm CM.CMINDC
CMDOSE Dose per Administration Num Perm CM.CMDOSE
CMDOSFRM Dose Form Char Perm CM.CMDOSFRM
CMDOSRGM Intended Dose Regimen Char Perm CM.CMDOSRGM
CMROUTE Route of Administration Char Perm CM.CMROUTE
3.2.9 Standardized MedDRA Query Variables

Standardized MedDRA Queries (SMQs) [13] are becoming increasingly common in clinical trial safety evaluations, particularly when known or suspected safety
issues are associated with experimental compounds. In addition, Customized MedDRA Queries (CMQs) are often used to modify an SMQ or identify Adverse
Event or Medical History records of special interest. The following variables are used to identify SMQs and CMQs, where the ‘zz’ indicates a number starting
with 01 for each SMQ or CQ of interest. This ordering can be based on importance or some other producer-defined criteria. It is recommended that the ordering
be consistent across studies within a development program, but it is recognized that there may be situations where this is not possible or practical.
Table 3.2.9.1 Standardized MedDRA Query Variables

SMQzzNAM SMQ zz Name Char Cond The standardized MedDRA queries name. Would be blank for terms that are not in the SMQ. Therefore this
variable could be blank for all records if no terms within the study were included in the SMQ.
Conditional on whether SMQ analysis is done.
SMQzzCD SMQ zz Code Num Perm The standardized MedDRA queries number code.
SMQzzSC SMQ zz Scope Char BROAD, Cond The search strategy for SMQs can be narrow or broad. The preferred terms that are narrow in scope have high
NARROW specificity for identifying events of interest while the broad terms have high sensitivity. By definition, all
narrow terms are also considered within the broad scope. Therefore, to summarize all broad terms, terms with
either narrow OR broad would be considered. Will be null for terms that do not meet the criteria.
Conditional on whether SMQ analysis is done.
SMQzzSCN SMQ zz Scope Num 1, 2 Perm Will be null for terms that do not meet the criteria.
(N)
CQzzNAM Customized Char Cond The customized query (CQ) name or name of the AE of special interest category based on a grouping of
Query zz terms. Would be blank for terms that are not in the CQ.
Name Conditional on whether CQ analysis is done.
Examples: “DERMATOLOGICAL EVENTS” “CARDIAC EVENTS”, “IARS (INFUSION ASSOCIATED
REACTIONS)”
3.2.10 Original or Prior Coding Variables

The suite of variables used for the primary analysis is described in section 3.2.3. Variables described here are those from original (or prior) analyses, and not used
directly for analysis from this data set.
Keeping multiple sets of mapping variables is not common, but there are a couple instances where it might be helpful:
• When a study is mapped to one version of a mapping dictionary for an interim analysis and another for final analysis
• When studies using different version of a mapping dictionary are pooled together for an integrated analysis
The variables described below provide traceability to original (or prior) analysis(es). The suffix “w” represents an integer [1-9] corresponding to a previous
version. Include the dictionary name and version as part of the metadata for each variable.
These variable names at this time are recommendations only. There is an ADaM sub-team currently working on integration, and this group may create different
naming conventions for that type of analysis.
Table 3.2.10.1 Original or Prior MedDRA Coding Variables

Variable Codelist /
DECDORGw PT in Original Dictionary w Char MedDRAw* Perm Original preferred term coding of XX.--TERM using MedDRA or other dictionary version
X.X.
BDSYORGw SOC in Original Dictionary w Char MedDRAw* Perm Original body system coding of XX.--TERM using MedDRA or other dictionary version
X.X.
HLGTORGw HLGT in Original Dictionary w Char MedDRAw* Perm Original HLGT coding of XX.--TERM using MedDRA or other dictionary version X.X
HLTORGw HLT in Original Dictionary w Char MedDRAw* Perm Original HLT coding of XX.--TERM using MedDRA or other dictionary version X.X.
LLTORGw LLT in Original Dictionary w Char MedDRAw* Perm Original LLT coding of XX.--TERM using MedDRA or other dictionary version X.X.
LLTNORGw LLT Code in Original Dictionary w Char MedDRAw* Perm Original LLT code of XX.--TERM using MedDRA or other dictionary version X.X.
* For each version of an external dictionary, a different reference name must be used. The individual reference names will point to a dedicated section in the data definition file
where all external dictionaries used in the analysis are listed, including dictionary name and version.
Table 3.2.10.2 Original or Prior WHO Drug Coding Variables

DECDORGw Standardized Med Name in Orig Dict w Char WHODRUGy* Perm Original standardized medication name of CM.CMTRT using WHO Drug
version X.X
CLASORGw Medication Class in Orig Dictionary w Char WHODRUGy* Perm Original medication class of CM.CMTRT using WHO Drug version X.X
CLCDORGw Medication Class Code in Orig Dict w Char WHODRUGy* Perm Original medication class code of CM.CMTRT using WHO Drug version X.X
ATyCORGw ATC Level y Code in Orig Dictionary w Char WHODRUGw* Perm Original ATC Level y code of CM.CMTRT using WHO Drug version X.X
ATyTORGw ATC Level y Text in Orig Dictionary w Char WHODRUGw* Perm Original ATC Level y text of CM.CMTRT using WHO Drug version X.X
* For each version of an external dictionary, a different reference name must be used. The individual reference names will point to a dedicated section in the data definition file
where all external dictionaries used in the analysis are listed, including dictionary name and version.
3.3 Other Metadata

Because OCCDS does not use parameters, there is typically no need for Value Level Metadata.
The other type of ADaM metadata which may be included is the Analysis Results Metadata. The CDISC Analysis Results Metadata Version 1.0 for Define-XML
Version 2 [14] has examples of how to represent Analysis Results Metadata.
4 Example 1: Analysis of Treatment Emergent

Adverse Event
The basic summary of adverse event frequencies described in section 12.2.2 (and located in section 14.3.1) of ICH
Guideline E3 [12] report should be used to display frequencies in treatment and control groups.
This example displays a simple summary of all treatment emergent adverse events. The example is based on a two
treatment parallel design study. The display summarizes (1) the number of subjects in each treatment group in whom
the adverse event occurred and (2) the rate of occurrence in each treatment group.
4.1 Analysis Display Example Layout

Table 4.1.1 Example of Summary of Treatment Emergent Adverse Events*
Table 14.2.7.1
Summary of Treatment Emergent Adverse Events by System Organ Class and Preferred Term
Analysis Population: Safety
Treatment A Treatment B
SYSTEM ORGAN CLASS (N = xxx) (N = xxx)
Preferred Term n (%) n (%)
Number of subjects reporting at least one adverse event x (x.x) x (x.x)
BLOOD AND LYMPHATIC SYSTEM DISORDERS

At least one event x (x.x) x (x.x)
Anaemia x (x.x) x (x.x)
… x (x.x) x (x.x)
CARDIAC DISORDERS
At least one event x (x.x) x (x.x)
Angina pectoris x (x.x) x (x.x)
Coronary artery disease x (x.x) x (x.x)
Ventricular tachycardia x (x.x) x (x.x)
Myocardial infarction x (x.x) x (x.x)
… x (x.x) x (x.x)
<Other SOCs and PTs>

Page 1 of x
N = Safety subjects, i.e., subjects who received at least one dose of study drug
n = Number of subjects reporting at least one treatment emergent adverse event
% = n / N * 100
Adverse events are presented by descending frequency within Treatment B
System organ classes and preferred terms are coded using MedDRA version x.x.
* The style of the display of the results of an analysis will be determined by the producer. The example is intended to illustrate content not
appearance.
4.2 Sample ADaM Variable Metadata

This example describes an adverse events ADaM dataset named ADAE. ADAE is not a required dataset name.
Table 4.2.1 Example of ADaM Variable Metadata

Dataset Variable Variable Codelist /
Variable Label Source / Derivation
Name Name Type Controlled Terms
ADAE STUDYID Study Identifier text AE.STUDYID
ADAE USUBJID Unique Subject text AE.USUBJID
Identifier
ADAE AESEQ Sequence Number integer AE.AESEQ
ADAE AETERM Reported Term for the text AE.AETERM
Adverse Event
ADAE AEDECOD Dictionary-Derived text MedDRA AE.AEDECOD
Term MedDRA Version 11.1
ADAE AEBODSYS Body System or Organ text MedDRA AE.AEBODSYS
Class MedDRA Version 11.1
ADAE TRTEMFL Treatment Emergent text Y If ADSL.TRTSDT <= ASTDT<=(ADSL.TRTEDT +14) then TRTEMFL=’Y’
Analysis Flag
ADAE PREFL Pre-treatment Flag text Y If ASTDT < ADSL.TRTSDT then PREFL=’Y’
ADAE FUPFL Follow-up Flag text Y If ASTDT > ADSL.TRTEDT+14 then FUPFL=’Y’
ADAE AESTDTC Start Date/Time of date ISO 8601 AE.AESTDTC
Adverse Event
ADAE ASTDT Analysis Start Date integer <Producer will insert derivation here>
ADAE ASTDTF Analysis Start Date text D, M, Y If start date is completely missing or missing the year then ASTDTF=’Y’
Imputation Flag Else if start date has month missing then ASTDTF=’M’
Else if start date has day missing then ASTDTF=’D’
ADAE AEENDTC End Date/Time of date ISO 8601 AE.AEENDTC
Adverse Event
ADAE AENDT Analysis End Date integer <Producer will insert derivation here>
ADAE AENDTF Analysis End Date text D, M, Y If end date is completely missing or missing the year then AENDTF=’Y’
Imputation Flag Else if end date has month missing then AENDTF=’M’
Else if end date has day missing then AENDTF=’D’
ADAE AESER Serious Event text Y, N AE.AESER
ADAE APHASE Phase text PRE-TREATMENT, If ASTDT<ADSL.TRTSDT, then APHASE=’PRE-TREATMENT’
TREATMENT, FOLLOW-UP Else if ASTDT > ADSL.TRTEDT + 14 days then APHASE=’FOLLOW-UP’,
Else APHASE=’TREATMENT’
ADAE AESEV Severity/Intensity text MILD, MODERATE, SEVERE AE.AESEV
ADAE ASEV Analysis text Mild, Moderate, Severe If AE.AESEV=’MILD’ then ASEV=’Mild’
Severity/Intensity Else if AE.AESEV=’MODERATE’ then ASEV=’Moderate’
Else if AE.AESEV is equal to ‘SEVERE’ or Severity/Intensity is missing then
ASEV=’Severe’

ADAE ASEVN Analysis integer 1, 2, 3 Map ASEV to ASEVN in the following manner:
Severity/Intensity (N) ‘Mild’ = 1
‘Moderate’ = 2
‘Severe’ = 3
ADAE AEREL Causality text NOT RELATED, AE.AEREL
UNLIKELY RELATED,
POSSIBLY RELATED,
PROBABLY RELATED,
DEFINITELY RELATED
ADAE RELGR1 Pooled Causality text Not Related, Related If AE.AEREL is equal to ‘NOT RELATED’ or ‘UNLIKELY RELATED’ then
Group 1 RELGR1=’Not Related’ Else if AE.AEREL is equal to ‘POSSIBLY RELATED’
or ‘PROBABLY RELATED’ or ‘DEFINITELY RELATED’ or Causality is
missing then RELGR1=’Related’
ADAE RELGR1N Pooled Causality integer 0, 1 Map RELGR1 to RELGR1N in the following manner:
Group 1 (N) ‘Not Related’ = 0
‘Related’ = 1
ADAE SAFFL Safety Population Flag text Y,N ADSL.SAFFL
ADAE AOCCFL 1st Occurrence within text Y Subset ADAE to Treatment Emergent Adverse Events (TRTEMFL=’Y’)
Subject Flag Sort by Subject (USUBJID), Analysis Start Date (ASTDT), and Sequence
Number (AESEQ) and flag the first record (set AOCCFL=’Y’) within each
Subject
ADAE AOCCSFL 1st Occurrence of text Y Subset ADAE to Treatment Emergent Adverse Events (TRTEMFL=’Y’)
SOC Flag Sort by Subject (USUBJID), System Organ Class (AEBODSYS), Analysis Start
Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set
AOCCSFL =’Y’) within each Subject and SOC
ADAE AOCCPFL 1st Occurrence of text Y Subset ADAE to Treatment Emergent Adverse Events (TRTEMFL=’Y’)
Preferred Term Flag Sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term
(AEDECOD) Analysis Start Date (ASTDT), and Sequence Number (AESEQ)
and flag the first record (set AOCCPFL =’Y’) within each Subject, SOC, and PT
ADAE TRTA Actual Treatment text Drug A, Drug B ADSL.TRT01A
ADAE TRTAN Actual Treatment (N) integer 1, 2 ADSL.TRT01AN
Drug A = 1
Drug B = 2
ADAE TRTSDT Date of First Exposure integer ADSL.TRTSDT
to Treatment
ADAE TRTEDT Date of Last Exposure integer ADSL.TRTEDT
to Treatment
ADAE AGE Age integer ADSL.AGE
ADAE AGEGR1 Pooled Age Group 1 text <65, >=65 ADSL. AGEGR1
ADAE SEX Sex text M, F ADSL.SEX
ADAE RACE Race text BLACK OR AFRICAN ADSL.RACE
AMERICAN, AMERICAN

INDIAN OR ALASKA
NATIVE, ASIAN, NATIVE
HAWAIIAN OR OTHER
PACIFIC ISLANDER, WHITE
4.3 Sample ADaM Data

Table 4.3.1 is an illustration of the adverse events analysis dataset (ADAE) defined above. The ADAE dataset illustrated in this example was designed to support
some standard subsets and/or classifications of treatment emergent adverse events including seriousness, severity, and relationship to study drug. The example
describes some of the key variables and records that would be included in the dataset.
Key points to note in the example are:

1. The producer of the dataset chose to use record level actual treatment variable (TRTA) populated with the same value across all rows in the dataset
rather than subject level treatment variable (TRT01A). For a parallel design either TRTA or TRT01A could be used as the actual treatment identifier.
The producer interpreted TRTA as the treatment associated with the record for analysis display purposes and populated the pre-treatment records with
treatment even though subjects had not yet received treatment at that time.
2. Variables such as AESEQ, AETERM, and AESTDTC are copied in from SDTM AE domain to provide data point traceability.
3. Variables such as AEBODSYS, AEDECOD, AESER, AESEV, and AEREL are copied in from the SDTM AE domain for analysis purposes.
4. ASTDT is the AE timing variable used for analysis. Other timing variables such as AENDT/ASTDTF/AENDTF/
AESTDTC/AEENDTC/TRTSDT/TRTEDT are supportive variables for metadata traceability.
5. The addition of ASEV and RELGR1 allow for the imputation of missing severity and grouping and imputation of Relationship to Study Drug as
specified in the Statistical Analysis Plan.
6. The Occurrence Flags (AOCC*FL) are permissible. The main purpose of these flags is to facilitate data point traceability between records in the dataset
and unique counts in the summary displays. In addition if a Time to Event (TTE) Analysis is built off of Adverse Events, the flags provide a crucial link
between the summary records in the TTE BDS and the source of the records in ADAE.
7. The core variables of AGE, AGEGR1, SEX, and RACE are included in ADAE to facilitate subgroup analyses.
Table 4.3.1 Sample ADaM Data

Row STUDYID USUBJID AESEQ AETERM AEDECOD AEBODSYS TRTEMFL PREFL FUPFL
1 XYZ XYZ-001-001 1 HEADACHE Headache Nervous system disorders Y
2 XYZ XYZ-001-001 2 CHRONIC BACK PAIN Back pain Musculoskeletal and connective tissue disorders Y
3 XYZ XYZ-001-001 3 NOSE BLEEDING RIGHT NOSTRIL Epistaxis Respiratory, thoracic and mediastinal disorders Y
4 XYZ XYZ-001-001 4 PROBLEMS OF HYPOTENSION Hypotension Vascular disorders Y
7 XYZ XYZ-001-001 7 LOOSE STOOL Diarrhoea Gastrointestinal disorders Y
8 XYZ XYZ-001-001 8 ABDOMINAL DISCOMFORT Abdominal discomfort Gastrointestinal disorders Y
9 XYZ XYZ-001-001 9 DIARRHEA Diarrhoea Gastrointestinal disorders Y
10 XYZ XYZ-001-001 10 ABDOMINAL FULLNESS DUE TO GAS Abdominal distension Gastrointestinal disorders Y
11 XYZ XYZ-001-001 11 NAUSEA (INTERMITTENT) Nausea Gastrointestinal disorders Y
Row STUDYID USUBJID AESEQ AETERM AEDECOD AEBODSYS TRTEMFL PREFL FUPFL
12 XYZ XYZ-001-001 12 WEAKNESS Asthenia General disorders and administration site conditions Y
15 XYZ XYZ-001-001 15 HYPOTENSIVE Hypotension Vascular disorders Y
Row AESTDTC* ASTDT* ASTDTF AEENDTC* AENDT* AENDTF AESER APHASE AESEV ASEV ASEVN AEREL
1 (cont) 2006-01 01JAN2006 D 2006-01-22 22JAN2006 N PRE-TREATMENT MILD Mild 1 NOT RELATED
2 (cont) 2006-01-21 21JAN2006 2006-01-28 28JAN2006 N PRE-TREATMENT MODERATE Moderate 2 NOT RELATED
3 (cont) 2006-01-22 22JAN2006 2006-01-22 22JAN2006 N PRE-TREATMENT MILD Mild 1 NOT RELATED
4 (cont) 23JAN2006 Y 15MAY2006 Y N TREATMENT MILD Mild 1 POSSIBLY RELATED
5 (cont) 2006-01-24 24JAN2006 2006-01 31JAN2006 D N TREATMENT MODERATE Moderate 2 PROBABLY RELATED
6 (cont) 2006-02 01FEB2006 D 2006-02-05 05FEB2006 N TREATMENT SEVERE Severe 3 PROBABLY RELATED
7 (cont) 2006-03-05 05MAR2006 2006-03-06 06MAR2006 N TREATMENT Severe 3 DEFINITELY RELATED
8 (cont) 2006-03-05 05MAR2006 2006 15MAY2006 M N TREATMENT MODERATE Moderate 2 DEFINITELY RELATED
9 (cont) 2006-03-17 17MAR2006 2006-03-18 18MAR2006 N TREATMENT MODERATE Moderate 2 DEFINITELY RELATED
10 (cont) 2006-03-17 17MAR2006 2006-03-19 19MAR2006 N TREATMENT MILD Mild 1 DEFINITELY RELATED
11 (cont) 2006-04-20 20APR2006 2006-04-22 22APR2006 N TREATMENT MILD Mild 1 PROBABLY RELATED
12 (cont) 2006-05-17 17MAY2006 2006-05-20 20MAY2006 N TREATMENT MILD Mild 1 POSSIBLY RELATED
13 (cont) 2006-05-20 20MAY2006 2006-05-22 22MAY2006 N TREATMENT MILD Mild 1 UNLIKELY RELATED
14 (cont) 2006-05-23 23MAY2006 2006-06-27 27JUN2006 N TREATMENT MILD Mild 1 UNLIKELY RELATED
15 (cont) 2006-05-21 27MAY2006 2006-05-25 29MAY2006 Y TREATMENT SEVERE Severe 3 UNLIKELY RELATED
16 (cont) 2006-06-01 01JUN2006 2006-06-01 01JUN2006 N FOLLOW-UP MILD Mild 1 UNLIKELY RELATED
* Variables ending in suffix DTC are character date/time fields in the ISO8601 format. Variables ending in DT are numeric dates, here shown using SAS date format date9. Other
numeric date formats can be used, but care should be taken with newer date formats which might not be understood by all statistical packages
Row RELGR1 RELGR1N SAFFL AOCCFL AOCCSFL AOCCPFL TRTA TRTAN TRTSDT* TRTEDT* AGE AGEGR1 SEX RACE
1 (cont) Not Related 0 Y Drug A 1 23JAN2006 15MAY2006 54 <65 M ASIAN
4 (cont) Related 1 Y Y Y Y Drug A 1 23JAN2006 15MAY2006 54 <65 M ASIAN
5 (cont) Related 1 Y Y Y Drug A 1 23JAN 2006 15MAY 2006 54 <65 M ASIAN
6 (cont) Related 1 Y Drug A 1 23JAN 2006 15MAY 2006 54 <65 M ASIAN
8 (cont) Related 1 Y Y Drug A 1 23JAN 2006 15MAY 2006 54 <65 M ASIAN
9 (cont) Related 1 Y Drug A 1 23JAN 2006 15MAY 2006 54 <65 M ASIAN
13 (cont) Not Related 0 Y Drug A 1 23JAN 2006 15MAY 2006 54 <65 M ASIAN
* Variables ending in DT are numeric dates, here shown using SAS date format date9. Other numeric date formats can be used, but care should be taken with newer date formats
which might not be understood by all statistical packages.
5 Example 2: Analysis of Hemorrhages (SMQ) among Treatment

Emergent Adverse Events by Sex
This example demonstrates how to incorporate SMQs into an AE analysis data set. In this example, an SMQ for hemorrhages is being used. This particular SMQ
is hierarchical with only narrow-scope terms, including terms referring to different types of hemorrhage, hematoma, bleeding, etc. (For a full description of
SMQs one may refer to the Maintenance and Support Services Organization (MSSO’s) Introductory Guide for Standardized MedDRA Queries [13].)

1. The exact name of the SMQ being used in this example is “Haemorrhages (SMQ)”. This precise terminology is used throughout the example.
2. As mentioned above, this particular SMQ contains only narrow scope terms. However, in order to illustrate best practice, the scope is also specified
when a reference is made to the SMQ. Although redundant in this particular case, it is important to show which scope is being used when providing
SMQ-based summaries since the scope can often have a profound effect on the percent of subjects who meet certain SMQ criteria.
5.1 Analysis Display Example Layouts

Table 5.1.1 Example of Summary of Haemorrhages (SMQ) (Narrow Scope) Adverse Events by Sex and Actual Treatment Group*
Table 14.2.7.3
Summary of Haemorrhages (SMQ) (Narrow Scope) Adverse Events by Sex and Actual Treatment Group
Gender n (%)
Females Males
B A B A
Preferred Term (N=281) (N=166) (N=297) (N=158)
Any Haemorrhages (SMQ) (Narrow Scope) Event 36 (8.0) 48 (10.5) 26 (8.8) 31 (19.6)
Cerebral haemorrhage 11 (2.4) 15 (3.3) 6 (2.0) 13 (8.2)
Conjunctival haemorrhage 0 1 (0.2) 0 0
Ecchymosis 1 (0.2) 0 0 0
Epistaxis 0 1 (0.2) 0 0
Extradural haematoma 1 (0.2) 0 1 (0.3) 1 (0.6)
Gastrointestinal haemorrhage 10 (2.2) 4 (0.9) 8 (2.7) 6 (3.8)
Haematuria 1 (0.2) 2 (0.4) 0 3 (1.9)
Haemoptysis 1 (0.2) 1 (0.2) 0 0
Haemorrhage 1 (0.2) 2 (0.4) 0 0
Infusion site haemorrhage 1 (0.2) 4 (0.9) 2 (0.7) 2 (1.3)
Melaena 0 0 0 1 (0.6)
Petechiae 0 1 (0.2) 0 0
Subarachnoid haemorrhage 14 (3.1) 24 (5.3) 12 (4.0) 11 (7.0)
Subdural haematoma 2 (0.4) 2 (0.4) 0 0
* The style of the display of the results of an analysis will be determined by the producer. The example is intended to illustrate content not appearance.
Figure 5.1.1 Example of Mosaic Plot of Haemorrhages (SMQ) (Narrow Scope) Preferred Terms by Sex and Actual Treatment Group*
Figure 14.2.7.1
Mosaic Plot of Hemorrhagic (SMQ) Preferred Terms by Sex and Actual Treatment Group
4
The style of the display of the results of an analysis will be determined by the producer. The example is intended to illustrate content not appearance.
Figure 5.1.2 Example of Haemorrhages (SMQ) (Narrow Scope) Preferred Terms Sorted by Relative Risk*
Figure 14.2.7.2
Hemorrhagic (SMQ) Preferred Terms Sorted by Relative Risk
Analysis Population: Safety Population
SMQ - HAEMORRHAGES
PETECHIAE
MELAENA
EPISTAXIS
ECCHYMOSIS
CONJUNCTIVAL HAEM
EXTRADURAL HAEMATOMA
GASTROINTESTINAL HAEM
SUBDURAL HAEMATOMA
HAEMOPTYSIS
SUBARACHNOID HAEM
CEREBRAL HAEMORRHAGE
HAEMORRHAGE
INFUSION SITE HAEM
HAEMATURIA
0 2 4 6 8 10 12 14 16 18 20 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7
Percent Relative Risk with 95% CI

B (n = 449)
A (n = 457)

This example describes an adverse events ADaM dataset named ADAE. ADAE is not a required dataset name. In Table 5.2.1 below, four variables relate to our
primary SMQ of interest (hemorrhage terms), SMQ01CD, SMQ01NAM SMQ01SC, and SMQ01SCN. The ‘01’ indicates that this is the first SMQ and
subsequent SMQs or subSMQs would be sequenced accordingly. Note that this ordering can be based on importance or some other producer-defined criteria. The
first two of these variables, SMQ01CD and SMQ01NAM contain the numeric code and name for the SMQ from the MedDRA dictionary. The next two
variables, SMQ01SC and SMQ01SCN, are character and numeric variables, respectively, that indicate not only whether or not the given AE meets the criteria for
the given SMQ, but also whether the term meets the SMQ’s broad or narrow scope (the ‘SC’ suffix is for “scope”).

Dataset Variable Codelist /
Variable Name Variable Label Source / Derivation
Name Type Controlled Terms
ADAE USUBJID Unique Subject Identifier text ADSL.USUBJID
ADAE AETERM Reported Term for the Adverse Event text AE.AETERM
ADAE AEDECOD Dictionary-Derived Term text MedDRA AE.AEDECOD
ADAE AEBODSYS Body System or Organ Class text MedDRA AE.AEBODSYS
ADAE ASTDT Analysis Start Date integer <Producer will insert derivation here>
ADAE AEPTCD Preferred Term Code integer AE.AEPTCD
ADAE SMQ01CD SMQ 01 Code integer SMQ01CD=20000039 if the AEPTCD is included in this SMQ.
ADAE SMQ01NAM SMQ 01 Name text SMQ01NAM=’Haemorrhage terms (excl. laboratory terms) (SMQ)’ if the
AEPTCD is included in this SMQ.
ADAE SMQ01SC SMQ 01 Scope text BROAD, NARROW For this given SMQ, all scopes are Narrow.
ADAE SMQ01SCN SMQ 01 Scope (N) integer 1, 2 Map SMQ01SC to SMQ01SCN in the following manner:
Broad = 1
Narrow = 2

Table 5.3.1: Sample ADaM Data Showing SMQ Variables
Row USUBJID AETERM AEDECOD AEBODSYS ASTDT* AEPTCD SMQ01CD SMQ01NAM SMQ01SC SMQ01SCN
SCLERAL BLEED Haemorrhage terms (excl
1 0092017 Scleral haemorrhage Eye disorders 09JUN2009 10050508 20000039 NARROW 2
RIGHT EYE laboratory terms) (SMQ)
BRUISING OF LEFT Injury, poisoning and Haemorrhage terms (excl
2 0112012 Contusion 27AUG2008 10050584 20000039 NARROW 2
UPPER ARM procedural complications laboratory terms) (SMQ)
BRUISING TO LEFT Injury, poisoning and Haemorrhage terms (excl
3 0112012 Contusion 22AUG2007 10050584 20000039 NARROW 2
WRIST procedural complications laboratory terms) (SMQ)
4 0112013 NAUSEA Nausea Gastrointestinal disorders 16JUN2010 10028813
Respiratory, thoracic and Haemorrhage terms (excl
5 0112014 NOSE BLEEDING Epistaxis 22NOV2009 10015090 20000039 NARROW 2
mediastinal disorders laboratory terms) (SMQ)
Respiratory, thoracic and Haemorrhage terms (excl
6 0122006 EPISTAXIS Epistaxis 06NOV2009 10015090 20000039 NARROW 2
mediastinal disorders laboratory terms) (SMQ)
6 Example 3: Analysis of Peripheral Sensory Neuropathy (PSN)

Adverse Events by Severity and Cumulative Dose Exposure
Some institutions and organizations use standardized coding guidelines for reporting of adverse events. Examples of such standardized scales are [NCI (National
Cancer Institute) and ACTG (Antiviral therapeutic area)]. These scales may be based upon variables as collected on AE CRFs, such as a grading scheme based
upon severity [AESEV/AESEVN]. Other guidelines may be so objective that some variables, for example, drug relatedness [AEREL/AERELN] are not captured.
In this example the adverse event analysis dataset is used to summarize the frequency of peripheral sensory neuropathy (PSN) by cumulative dose exposure in an
oncology study. In this study PSN was reported on the CRF at each cycle and at each 6-month follow-up visit, using the National Cancer Institute Common
Toxicity Criteria (NCI CTC) version 4.03 [10] Peripheral sensory neuropathy (MedDRA v12.0 Code = 10034620):
• Grade 0 = None;
• Grade 1 = Asymptomatic; loss of deep tendon reflexes or paresthesia;
• Grade 2 = Moderate symptoms; limiting instrumental ADL;
• Grade 3 = Severe symptoms; limiting self care ADL;
• Grade 4 = Life-threatening consequences; urgent intervention indicated;
• Grade 5 = Death.
As a result of using this means of reporting, the PSN events reported in this module were all coded to ‘paresthesia’.

Table 6.1.1 Example of Summary of Cumulative Dose Quartiles to First Onset for PSN by Severity Grade*
Table 14.2.7.4
Summary of cumulative dose quartiles to first onset for PSN by severity grade
Analysis population: Intent-to-treat
Number of PSN grade
patients Number (%) of Number (%) of Number (%) of Number (%) of patients
Cumulative dose Exposed patients with grade ≥ 1 patients with grade ≥ 2 patients with grade ≥ 3 with grade 4 or 5
Total number of patients with PSN x (x.x) x (x.x) x (x.x) x (x.x)
1st quartile (3 cycles) N x (x.x) x (x.x) x (x.x) x (x.x)
2nd quartile (6 cycles) N x (x.x) x (x.x) x (x.x) x (x.x)
3rd quartile (9 cycles) N x (x.x) x (x.x) x (x.x) x (x.x)
4th quartile (12 cycles) N x (x.x) x (x.x) x (x.x) x (x.x)
Median cumulative dose to first X X X X
onset (mg/m2)

Table 6.2.1: Sample ADaM Variable Metadata for selected variables

ADAE USUBJID Unique Subject text ADSL.USUBJID
Identifier
ADAE ITTFL Intent-to-Treat text Y,N ADSL.ITTFL
Population Flag
Term
ADAE AETOXGR Standard Toxicity text 1, 2, 3, 4, 5 AE.AETOXGR
Grade
ADAE AETOXGRN Standard Toxicity integer 1, 2, 3, 4, 5 Code AE.AETOXGR to numeric
Grade (N)
ADAE DOSCUMA Cumulative Actual float Total all values of EX.EXDOSE for the subject up to the start of the AE.
Treatment Dose
ADAE DOSEU Treatment Dose text mg EX.EXDOSEU
Units
ADAE DOSCMGR1 Cumulative Dose text Quartile 1, Quartile 2, Missing if DOSCUMA=0, else DOSCMGR1 = Quartile 1 if DOSCUMA is in the
Group 1 Quartile 3, Quartile 4 1st Quartile, Quartile 2 if in the 2nd Quartile, Quartile 3 if in the 3rd Quartile and
Quartile 4 if in the 4th Quartile.

1. Variable DOSCMGR1 is not a standard variable. It has been added for analysis purposes and uses the naming conventions from the ADaMIG.
2. This is a simple example to only illustrate the cumulative dose variables that can be added to ADAE. It does not include additional variables that would
also be needed for analysis like a flag to indicate the first occurrence for PSN.
3. Row 3 and 7 include two patients who had no dose of study drug at the time of PSN and would not be included in the table.
Table 6.3.1: Sample ADaM Data Showing Cumulative Dose Variables

Row USUBJID ITTFL AEDECOD AETOXGR AETOXGRN DOSCUMA DOSEU DOSCMGR1
1 101-002 Y PARESTHESIA 3 3 247.06 mg Quartile 1
3 101-005 Y PARESTHESIA 1 1 0 mg
7 101-012 Y PARESTHESIA 1 1 0 mg
7 Example 4: Analysis of Treatment Emergent

Adverse Events in a Cross-Over Interaction Study
This example is a phase I, open-label, three period cross-over study. Subjects are treated for 7 days within each
period with a 7 day wash-out between periods. In each period, subjects are to receive one of 3 treatments (A, B, or A
+ B combined) in order of the sequence they are randomized to. Treatment emergent AEs were defined as AEs that
occurred or worsened from the start of the treatment period through 72 hours after the end of the treatment period.
Non-treatment emergent AEs were those that occurred before the first treatment period or more than 72 hours after
the end of the treatment period until the start of the next treatment period. Post-treatment emergent AEs were those
that occurred more than 72 hours after the last treatment period.
In addition to standard cross-over analysis, this example also includes analysis using both a primary and a secondary
coding path.

Table 7.1.1 Example of Summary of Treatment Emergent AEs by System Organ Class and Preferred Term
and Treatment Group*
Table 14.2.7.5
Summary of Treatment Emergent AEs by System Organ Class and Preferred Term and Treatment Group
Treatment A Treatment B Treatment A + B
(N = xxx) (N = xxx) (N = xxx)
SYSTEM ORGAN CLASS n (%) No. of n (%) No. of n (%) No. of
Preferred Term events events events
Any TEAE x (x.x) x x (x.x) x x (x.x) x
GASTROINTESTINAL DISORDER x (x.x) x x (x.x) x x (x.x) x

Nausea x (x.x) x x (x.x) x x (x.x) x
Constipation x (x.x) x x (x.x) x x (x.x) x
Vomiting x (x.x) x x (x.x) x x (x.x) x
Diarrhoea x (x.x) x x (x.x) x x (x.x) x
INFECTIONS AND INFESTATIONS x (x.x) x x (x.x) x x (x.x) x
Pharyngitis x (x.x) x x (x.x) x x (x.x) x
NERVOUS SYSTEM DISORDERS x (x.x) x x (x.x) x x (x.x) x
Headache x (x.x) x x (x.x) x x (x.x) x
Dizziness x (x.x) x x (x.x) x x (x.x) x
Syncope x (x.x) x x (x.x) x x (x.x) x
<Other SOCs and PTs>
TEAE = treatment emergent adverse event
N = Safety subjects, i.e., subjects who received at least one dose of study drug in that particular period
n = Number of subjects reporting at least one treatment emergent adverse event
% = n / N * 100
Adverse events are presented by descending frequency of SOC and PT within SOC within Treatment A+B
System organ classes and preferred terms are coded using MedDRA version x.x.
appearance.

Table 7.2.1: Sample ADaM Variable Metadata for selected variables

ADAE USUBJID Unique Subject text ADSL.USUBJID
Identifier
ADAE TRTA Actual Treatment text Treatment A, Treatment B, ADSL.TRT01A if in the 1st period, ADSL.TRT02A if in the 2nd period,
Treatment A+B or ADSL.TRT03A if in the 3rd period
ADAE TRTAN Actual Treatment integer 1, 2, 3 Code TRTA to numeric.
Treatment A = 1
Treatment B = 2
Treatment A+B = 3
ADAE SAFFL Safety Population Flag text Y,N ADSL.SAFFL
ADAE AEBODSYS Body System or Organ text MedDRA AE.AEBODSYS
Class
Term
ADAE ASTDTM Analysis Start integer Converting AE.AESTDTC from character ISO8601 format to numeric
Date/Time date format, applying producer defined imputation rules.
ADAE ASTDTF Analysis Start Date text D, M, Y The level of imputation done for the start date (D if day was imputed, M
Imputation Flag if month was imputed, or Y if year was imputed).
ADAE ASTTMF Analysis Start Time text M, H The level of imputation done for the start time (H if hour was imputed, M
Imputation Flag if minutes were imputed).
ADAE TRTEMFL Treatment Emergent text Y If ADSL.TR01SDTM LE ASTDTM LE (ADSL.TR01EDTM+72 hours)
Analysis Flag or ADSL.TR02SDTM LE ASTDTM LE (ADSL.TR02EDTM+72 hours)
or ADSL.TR03SDTM LE ASTDTM LE (ADSL.TR03EDTM+72 hours)
then TRTEMFL=Y
ADAE PREFL Pre-treatment Flag text Y If TRTEMFL ^=’Y’ and FUPFL^=’Y’ then PREFL=’Y’
ADAE FUPFL Follow-up Flag text Y if ASTDTM GT (ADSL.TR03EDTM+72 hours) then FUPFL=’Y’
ADAE ASTDY Analysis Start Relative integer Date portion of ASTDTM- date portion of ADSL.TRT01SDTM+1 day if
Day date portion of ASTDTM is on or after date portion of TRT01SDTM,
else date portion of ASTDTM- date portion of ADSL.TR01SDTM if date
portion of ASTDTM precedes date portion of TR01SDTM
ADAE EPOCH Epoch text RUN-IN, FIRST TREATMENT, AE.EPOCH
FIRST WASHOUT, SECOND
TREATMENT, SECOND WASHOUT,
THIRD TREATMENT, FOLLOW-UP
ADAE APHASE Phase text RUN-IN, FIRST TREATMENT, If AESDTM < ADSL.TR01SDTM then APHASE=’RUN-IN’, else
FIRST WASHOUT, SECOND ifADSL.TR01SDTM LE AESDTM LE(ADSL.TR01EDTM+72 hours)

TREATMENT, SECOND WASHOUT, then APHASE =’FIRST TREATMENT’, else if(ADSL.TR01EDTM+72
THIRD TREATMENT, FOLLOW-UP hours) < AESDTM< ADSL.TR02SDTM then APHASE=’FIRST
WASHOUT’, etc.
ADAE APERIOD Period integer 1, 2, 3 If TR01SDTM LE ASTDTM LE (TR01EDTM+72 hours) then
APERIOD=1, else if TR02SDTM LE ASTDTM LE (TR02EDTM+72
hours) then APERIOD=2, else if TR03SDTM LE ASTDTM LE
(TR03EDTM+72 hours) then APERIOD=3,
ADAE APERIODC Period (C) text PERIOD 01, PERIOD 02, PERIOD 03 If APERIOD=1 then APERIODC=’PERIOD 01’, else if APERIOD=2
then APERIODC=’PERIOD 02’, else if APERIOD=03 then
APERIODC=’PERIOD 03’
ADAE TR01SDTM Datetime of First integer ADSL.TR01SDTM
Exposure in Period 01
ADAE TR01EDTM Datetime of Last integer ADSL.TR01EDTM

Table 7.3.1 is an illustration of the adverse events analysis dataset (ADAE) defined above.

1. The SDTM variable EPOCH was kept for traceability and to illustrate the differences between this variable and APHASE and APERIOD.
2. Treatment start and end datetimes for each period were kept and used to calculate APERIOD and TRTEMFL. Another option would have been to use
ADSL variables relating to period start and end datetimes (APxxSDTM and APxxEDTM). However, if different periods for efficacy and safety were
defined this latter option wouldn’t work.
3. The producer of the dataset chose to populate APERIOD as an analysis period where the wash-out and follow-up period were not populated for
APERIOD. The same applied for the record level actual treatment variable (TRTA) which was left missing for records not associated with a treatment.
However, this is left up to the producer.
4. Row 5 indicates an AE that occurs in the follow-up EPOCH, is post-treatment emergent and not related to any analysis period or treatment.
5. Row 8 indicates an AE that occurs in the follow-up epoch but within the third treatment phase and analysis period and associated with treatment A + B.
Table 7.3.1: Sample ADaM Data

Row USUBJID TRTA TRTAN SAFFL AEBODSYS AEDECOD ASTDTM* ASTDTF ASTTMF TRTEMFL PREFL FUPFL ASTDY EPOCH
GASTROINTESTINAL FIRST
1 101-001 A 1 Y VOMITING 05MAY08:16:00:00 M Y 5
DISORDERS TREATMENT
INFECTIONS AND SECOND
2 101-001 B 2 Y PHARYNGITIS 16MAY08:06:42:00 Y 16
INFESTATIONS TREATMENT
NERVOUS SYSTEM THIRD
3 101-001 A+B 3 Y HEADACHE 01JUN08:15:30:00 Y 32
DISORDERS TREATMENT
4 101-001 A+B 3 Y CONSTIPATION 02JUN08:07:15:00 Y 33
DISORDERS TREATMENT
INFECTIONS AND
5 101-001 Y ORAL HERPES 07JUN08:08:00:00 Y 38 FOLLOW-UP
INFESTATIONS
VASCULAR SECOND
6 101-002 Y HYPOTENSION 25MAY08:13:20:00 Y 26
DISORDERS WASHOUT
7 101-002 A+B 3 Y HEADACHE 27MAY08:22:10:00 Y 28
DISORDERS TREATMENT
NERVOUS SYSTEM
8 101-002 A+B 3 Y HEADACHE 02JUN08:22:10:00 Y 34 FOLLOW-UP
DISORDERS
* Variables ending in DTM are numeric datetimes, here shown using SAS format datetime16. Other numeric datetime formats can be used, but care should be taken with newer
formats which might not be understood by all statistical packages.
Row APHASE APERIOD APERIODC TR01SDTM* TR01EDTM* TR02SDTM* TR02EDTM* TR03SDTM* TR03EDTM*
1 (cont) FIRST TREATMENT 1 PERIOD 01 01MAY08:10:05:00 07MAY08:09:10:10 15MAY08:08:15:00 21MAY08:10:30:00 20MAY08:13:50:00 03JUN08:07:20:00
2 (cont) SECOND TREATMENT 2 PERIOD 02 01MAY08:10:05:00 07MAY08:09:10:00 15MAY08:08:15:00 21MAY08:10:30:00 29MAY08:13:50:00 03JUN08:07:20:00
3 (cont) THIRD TREATMENT 3 PERIOD 03 01MAY08:10:05:00 07MAY08:09:10:00 15MAY08:08:15:00 21MAY08:10:30:00 29MAY08:13:50:00 03JUN08:07:20:00
4 (cont) THIRD TREATMENT 3 PERIOD 03 01MAY08:10:05:00 07MAY08:09:10:00 15MAY08:08:15:00 21MAY08:10:30:00 29MAY08:13:50:00 03JUN08:07:20:00
5 (cont) FOLLOW-UP 01MAY08:10:05:00 07MAY08:09:10:00 15MAY08:08:15:00 21MAY08:10:30:00 29MAY08:13:50:00 03JUN08:07:20:00
6 (cont) SECOND WASHOUT 30APR08:12:05:00 06MAY08:08:32:00 14MAY08:11:55:00 20MAY08:08:10:00 26MAY08:15:40:00 01JUN08:09:13:00
7 (cont) THIRD TREATMENT 3 PERIOD 03 30APR08:12:05:00 06MAY08:08:32:00 14MAY08:11:55:00 20MAY08:08:10:00 26MAY08:15:40:00 01JUN08:09:13:00
8 (cont) THIRD TREATMENT 3 PERIOD 03 30APR08:12:05:00 06MAY08:08:32:00 14MAY08:11:55:00 20MAY08:08:10:00 26MAY08:15:40:00 01JUN08:09:13:00
* Variables ending in DTM are numeric datetimes, here shown using SAS format datetime16. Other numeric datetime formats can be used, but care should be taken with newer
formats which might not be understood by all statistical packages.
8 Example 5: MedDRA Secondary Path

In MedDRA, a collected term can be mapped along more than one path, as shown in the diagram below.
Whenever more than one path is possible, there is always a primary Figure 8.1: Possible MedDRA Coding Paths for term "Dizziness" [15]
coding path plus one or more secondary paths. When a secondary path
will be used for analysis, SDTMIG version 3.2 allows for capture of
both a primary and secondary System Organ Class (SOC), as described
in the CDISC Notes column for these variables:
• AEBODSYS: “Dictionary derived. Body system or organ
class used by the sponsor from the coding dictionary (e.g.,
MedDRA). When using a multi-axial dictionary such as
MedDRA, this should contain the SOC used for the sponsor’s
analyses and summary tables which may not necessarily be
the primary SOC.”
• AESOC: “Dictionary-derived text description of the primary
System Organ Class. Will be the same as AEBODSYS if the
primary SOC was used for analysis.”
As with other SDTM variables, these are typically copied from SDTM
to ADaM and used directly in the occurrence analysis.
This section describes different ways to handle multiple coding paths
and gives an example on how to create a single analysis dataset with
two different coding paths.
Typically adverse event analysis includes only the primary coding path.
However, some indications also perform analysis on the secondary
path. For example in study of brain cancer, a headache might need to be
analyzed according to a secondary path that attributes this to the cancer.
This is why SDTM has the option of including two different paths.
When a secondary path is used, often the analysis need is:

• One set of tables showing primary path, such as shown in section 4, using AESOC for analysis.
• Another separate set of tables showing secondary path, similar to what is shown in section 4 but using AEBODSYS for analysis.
For this type of analysis need, analysis can be made straightforward by creating one dataset for the primary path tables, and a separate dataset for the secondary
path tables. The remainder of this section describes an analysis need beyond this, where both primary and secondary analyses are performed on the same table.
8.1 Analysis Display Example

The analysis need is to produce the following table:
Table 8.1.1: Example Analysis Display*

Table 14.2.8.3
Treatment Emergent AEs by Primary and Secondary SOCs, Preferred Term
(Population: Safety Subjects)
Placebo (n=xxx) Drug X (n=xxx)
System Organ Class Primary SOC Primary + Secondary Primary SOC Primary + Secondary
Preferred Term n (%) SOC n (%) n (%) SOC n (%)
CARDIAC DISORDERS 0 ( x.x) 0 ( x.x) 0 ( x.x) 1 ( x.x)
Dizziness [2] 0 ( x.x) 0 ( x.x) 0 ( x.x) 1 ( x.x)
ENDOCRINE DISORDERS 0 ( x.x) 1 ( x.x) 2 ( x.x) 2 ( x.x)
Autoimmune thyroiditis [1] 0 ( x.x) 0 ( x.x) 1 ( x.x) 1 ( x.x)
Thyroid atrophy[1] 0 ( x.x) 1 ( x.x) 1 ( x.x) 1 ( x.x)
NERVOUS SYSTEM DISORDERS 2 ( x.x) 2 ( x.x) 1 ( x.x) 1 ( x.x)
VASCULAR DISORDERS 0 ( x.x) 1 ( x.x) 0 ( x.x) 0 ( x.x)
SOC = System Organ Class;

[1] Preferred term comes from primary system organ class path
[2] Preferred term comes from secondary system organ class path
8.2 Sample SDTM AE Data

As described above in the introduction to this section, both SDTM variables AEBODSYS and AESOC are included in the SDTM AE data, and each represents a
different coding path used for analysis. In table 8.2.1 below, notice that AEBODSYS and AESOC are the same on some rows but different on others. When only
a primary path is to be used, the values of AEBODSYS and AESOC are the same. When a secondary path is to be used, AEBODSYS and AESOC are different.
For the purpose of this example we see that the AE Dizziness was coded to different MedDRA coding paths in different subjects based on further information
available.
Table 8.2.1: Sample SDTM AE data for selected variables

Row STUDYID USUBJID AESEQ AEDECOD AEBODSYS AESTDTC AESOC
1 XYZ XYZ-1-001 1 Autoimmune thyroiditis Endocrine disorders 2008-05-13 Endocrine disorders
2 XYZ XYZ-1-001 2 Dizziness Cardiac disorders 2008-06-13 Nervous system disorders
3 XYZ XYZ-2-002 1 Dizziness Vascular disorders 2008-09-13 Nervous system disorders
4 XYZ XYZ-3-003 1 Thyroid atrophy Endocrine disorders 2008-09-13 Endocrine disorders
5 XYZ XYZ-4-004 1 Dizziness Nervous system disorders 2008-09-09 Nervous system disorders

As mentioned earlier in this section, a typical way to analyze adverse event data with multiple paths is to split the different coding paths into separate analysis
datasets. Each analysis dataset would contain the records from the SDTM AE dataset, but one dataset would use AEBODSYS for analysis and the other would
use AESOC. Dataset metadata, including dataset labels and documentation, would explain the different datasets and their individual analysis purposes.
In this case, the data were kept in a single analysis dataset, with rows for each coding path, as shown in table 8.3.1, to facilitate analysis for the table shown in
table 8.1.1.

1. The analysis record flag variables can be used to differentiate between primary path and secondary path records. In this example, ANL01FL is used to
identify the primary coding path and ANL02FL is used to identify the secondary coding path.
2. Row 2 and 3 represent a single adverse event of Dizziness from SDTM. It was coded to two system organ classes: Nervous system disorders (primary
SOC) and Cardiac disorders (original coding). Both rows in ADAE have the same value of AESEQ.
3. Rows 4 and 5 represent a single adverse event of Dizziness. It was coded to two system organ classes: Nervous system disorders (primary SOC) and
Vascular disorders (original coding). Both rows in ADAE have the same value of AESEQ.
4. Rows 6-7 use only one path, so no additional records are necessary.
5. AEBODSYS and AESOC are unchanged from SDTM. New variable ASOC is added as an analysis version of the body system to facilitate the analysis.
ASOC is not a required name.
6. The purpose of this example is not to state how MedDRA secondary paths are to be handled, only to provide an example.
Table 8.3.1: Sample ADaM ADAE data for selected variables

Row USUBJID TRTA AESEQ AEDECOD AEBODSYS AESOC ASOC ANL01FL ANL02FL
1 XYZ-1-001 Drug X 1 Autoimmune thyroiditis Endocrine disorders Endocrine disorders Endocrine disorders Y
2 XYZ-1-001 Drug X 2 Dizziness Cardiac disorders Nervous system disorders Cardiac disorders Y
3 XYZ-1-001 Drug X 2 Dizziness Cardiac disorders Nervous system disorders Nervous system disorders Y
4 XYZ-2-002 Placebo 1 Dizziness Vascular disorders Nervous system disorders Vascular disorders Y
5 XYZ-2-002 Placebo 1 Dizziness Vascular disorders Nervous system disorders Nervous system disorders Y
6 XYZ-3-003 Drug X 1 Thyroid atrophy Endocrine disorders Endocrine disorders Endocrine disorders Y
7 XYZ-4-004 Placebo 1 Dizziness Nervous system disorders Nervous system disorders Nervous system disorders Y
9 Example 6: Analysis of Concomitant Medications

This example displays a simple summary of all concomitant medications. The example is based on a two treatment
parallel design study. The display summarizes (1) the number of patients in each treatment group who took a
concomitant medication and (2) the rate of occurrence in each treatment group. In this example, analysis results
metadata have not been included. As stated in the ADaMIG, analysis results metadata are not needed or even
advisable for every analysis included in a clinical study report or submission.

Table 9.1.1 Example of Summary of Concomitant Medications*
Table 14.1.5
Summary of Concomitant Medications by Medication Class and Preferred Term
Treatment A Treatment B Total
Medication Class/Preferred Term (N=4) (N=5) (N=9)
Any Concomitant Medication 4 (100.0%) 4 (80.0%) 8 (88.9%)
ANALGESICS 2 (50.0%) 2 (40.0%) 4 (44.4%)

PARACETAMOL 2 (50.0%) 2 (40.0%) 4 (44.4%)
ANTIBACTERIALS FOR SYSTEMIC USE 1 (25.0%) 1 (20.0%) 2 (22.2%)
AMOXICILLIN 1 (25.0%) 1 (20.0%) 2 (22.2%)
ANTIINFLAMMATORY AND ANTIRHEUMATIC 1 (25.0%) 2 (40.0%) 3 (33.3%)
PRODUCTS
IBUPROFEN 1 (25.0%) 2 (40.0%) 3 (33.3%)
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES 0 2 (40.0%) 2 (22.2%)
MONTELUKAST 0 1 (20.0%) 1 (11.1%)
SALBUTAMOL 0 2 (40.0%) 2 (22.2%)
NASAL PREPARATIONS 2 (50.0%) 0 2 (22.2%)
FLUTICASONE PROPIONATE 2 (50.0%) 0 2 (22.2%)
PSYCHOANALEPTICS 1 (25.0%) 0 1 (11.1%)
SERTRALIN 1 (25.0%) 0 1 (11.1%)
appearance.

This example describes an adverse events ADaM dataset named ADCM. ADCM is not a required dataset name.

ADCM STUDYID Study Identifier text CM.STUDYID
ADCM USUBJID Unique Subject Identifier text CM.USUBJID
ADCM CMSEQ Sequence Number integer CM.CMSEQ
ADCM CMTRT Reported Name of Drug, Med or Therapy text CM.CMTRT
ADCM CMMODIFY Modified Reported Name text CM.CMMODIFY
ADCM CMDECOD Standardized Medication Name text WHODRUG CM.CMDECOD
WHO Drug Dictionary March 2012
ADCM ATC1CD ATC Level 1 Code text WHODRUG ATC Level 1 Code
ADCM ATC1 ATC Level 1 Text text WHODRUG ATC Level 1 Text
ADCM AOCCFL 1st Occurrence within Subject Flag text Y <Producer will insert derivation here>
ADCM AOCC01FL First Occurrence of ATC Level 1 Flag text Y <Producer will insert derivation here>
ADCM AOCCPFL 1st Occurrence of Preferred Term Flag text Y <Producer will insert derivation here>
ADCM CMINDC Indication text CM.CMINDC
ADCM CMDOSFRM Dose Form text TABLET CM.CMDOSFRM
ADCM CMDOSE Dose per Administration text CM.CMDOSE
ADCM CMDOSU Dose Units text mg CM.CMDOSU
ADCM CMDOSFRQ Dosing Frequency Per Interval text ONCE, PRN, QD, QID CM.CMDOSFRQ
ADCM CMROUTE Route of Administration text ORAL CM.CMROUTE
ADCM CMSTDTC Start Date/Time of Medication date ISO 8601 CM.CMSTDTC
ADCM ASTDT Analysis Start Date integer date9. <Producer will insert derivation here>
ADCM ASTDTF Analysis Start Date Imputation Flag text D, M, Y If start date is completely missing or missing the year then ASTDTF=’Y’
Else if start date has month missing then ASTDTF=’M’
Else if start date has day missing then ASTDTF=’D’
ADCM CMENDTC End Date/Time of Medication date ISO 8601 CM.CMENDTC

ADCM AENDT Analysis End Date integer date9. <Producer will insert derivation here>
ADCM AENDTF Analysis End Date Imputation Flag text D, M, Y If end date is completely missing or missing the year then AENDTF=’Y’
Else if end date has month missing then AENDTF=’M’
Else if end date has day missing then AENDTF=’D’
ADCM CMENRF End Relative to Reference Period text ONGOING CM.CMENRF
ADCM ONTRTFL On-Treatment Flag text Y <Producer will insert derivation here>
ADCM PREFL Pre-treatment Flag text Y <Producer will insert derivation here>
ADCM SAFFL Safety Population Flag text Y,N ADSL.SAFFL
ADCM TRTA Actual Treatment text Drug A, Drug B ADSL.TRT01A
ADCM TRTAN Actual Treatment (N) integer 1, 2 ADSL.TRT01AN
Drug A = 1
Drug B = 2
ADCM TRTSDT Date of First Exposure to Treatment integer date9. ADSL.TRTSDT
ADCM TRTEDT Date of Last Exposure to Treatment integer date9. ADSL.TRTEDT
ADCM AGE Age integer ADSL.AGE
ADCM AGEGR1 Pooled Age Group 1 text <65, >=65 ADSL. AGEGR1
ADCM SEX Sex text M, F ADSL.SEX
ADCM RACE Race text ASIAN ADSL.RACE

Table 9.3.1 is an illustration of the concomitant medications analysis dataset (ADCM) defined above. The ADCM dataset illustrated in this example was
designed to support some standard subsets and/or classifications of concomitant medications. The example describes some of the key variables and records that
would be included in the dataset.

1. The producer of the dataset chose to use the record level actual treatment variable (TRTA) populated with the same value across all rows in the dataset
rather than the subject level treatment variable (TRT01A). For a parallel design either TRTA or TRT01A could be used as the actual treatment
identifier. The producer interpreted TRTA as the treatment associated with the record for analysis display purposes and populated the baseline records
with treatment even though subjects had not yet received treatment at that time.
2. Variables such as CMSEQ, CMTRT, and CMSTDTC are copied in from SDTM CM domain to provide data point traceability.
3. Variables such as CMDECOD are copied in from the SDTM CM domain for analysis purposes.
4. ASTDT and AENDT are the CM timing variables used for analysis. Other timing variables such as ASTDTF/AENDTF/
CMSTDTC/CMENDTC/TRTSDT/TRTEDT are supportive variables for metadata traceability.
5. The Occurrence Flags (AOCCFL, AOCCPFL, AOCC01FL, AOCC02FL, AOCC03FL) are permissible, and not required. The main purpose of these
flags is to facilitate data point traceability between records in the dataset and unique counts in the summary displays. In addition if a Time to Event
Analysis is built off of Concomitant Medications, the flags provide a crucial link between the summary records in the TTE BDS and the source of the
records in ADCM.
6. The core variables of AGE, AGEGR1, SEX, and RACE are included in ADCM to facilitate subgroup analyses.
Table 9.3.1 Sample ADCM Data

Row STUDYID USUBJID CMSEQ CMTRT CMMODIFY CMDECOD ATC1CD ATC1 ATC2CD
1 ABC ABC-001 1 TYLENOL TYLENOL PARACETAMOL N NERVOUS SYSTEM N02
5 ABC ABC-001 5 CONTAC MS CONTAC MS CONTAC MS N NERVOUS SYSTEM N02
6 ABC ABC-001 6 FLONASE FLONASE FLUTICASONE PROPIONATE R RESPIRATORY SYSTEM R01
7 ABC ABC-002 1 ROBITUSSIN COUGH ROBITUSSIN NOVAHISTINE DMX R RESPIRATORY SYSTEM R05
8 ABC ABC-002 2 MOTRIN MOTRIN IBUPROFEN M MUSCULO-SKELETAL SYSTEM M01
9 ABC ABC-002 3 IBUPROFEN IBUPROFEN IBUPROFEN M MUSCULO-SKELETAL SYSTEM M01
10 ABC ABC-003 1 ZOLLOFT ZOLOFT SERTRALIN N NERVOUS SYSTEM N06
Row ATC2 ATC3CD ATC3 AOCCFL AOCCPFL

1 (cont) ANALGESICS N02B OTHER ANALGESICS AND ANTIPYRETICS Y Y
2 (cont) ANALGESICS N02B OTHER ANALGESICS AND ANTIPYRETICS
5 (cont) ANALGESICS N02B OTHER ANALGESICS AND ANTIPYRETICS Y
6 (cont) NASAL PREPARATIONS R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOP Y
7 (cont) COUGH AND COLD PREPARATIONS R05FA COUGH SUPPRESSANTS AND EXPECTORANTS, COMBINATIONS Y
8 (cont) ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS M01A ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-S Y
9 (cont) ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS M01A ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-S
10 (cont) PSYCHOANALEPTICS N06A ANTIDEPRESSANTS Y
Row AOCC01FL AOCC02FL AOCC03FL CMINDC CMDOSFRM CMDOSE CMDOSU CMDOSFRQ CMROUTE CMSTDTC* ASTDT* CMENDTC*
1 (cont) Y Y Y HEADACHE TABLET 100 mg ONCE ORAL 2011-01-02 02Jan2011 2011-01-02
2 (cont) HEADACHE TABLET 100 mg ONCE ORAL 2011-01-04 04Jan2011 2011-01-04
5 (cont) COLD TABLET 200 mg ONCE ORAL 2011-01-17 17Jan2011 2011-01-17
6 (cont) Y Y Y COUGH TABLET 50 mg QD ORAL 2009-02-01 01Feb2009
7 (cont) Y Y INFECTION SUSPENSION 500 mg QID ORAL 2011-03-01 01Mar2011 2011-03-15
8 (cont) Y Y Y LEG PAIN TABLET 500 mg PRN ORAL 2011-05-14 14May2011 2011-06-01
9 (cont) ARTHRITIS TABLET 250 mg QD ORAL 2011-06-10 10Jun2011
10 (cont) Y Y Y ANXIETY TABLET 50 mg QD ORAL 2001-03
numeric date formats can be used, but care should be taken with newer date formats which might not be understood by all statistical packages.
Row AENDT* CMENRF ONTRTFL PREFL SAFFL TRTA TRTAN TRTSDT* TRTEDT* AGE AGEGR1 SEX RACE
1 (cont) 02Jan2011 Y Y Drug A 1 23JAN2011 15MAY2011 54 <65 M ASIAN
4 (cont) 15Jan2011 Y Y Drug A 1 23JAN 2011 15MAY2011 54 <65 M ASIAN
6 (cont) ONGOING Y Y Y Drug A 1 23JAN2011 15MAY2011 54 <65 M ASIAN
7 (cont) 15Mar2011 Y Y Drug B 2 10MAY2011 25NOV201 54 <65 M ASIAN
Row AENDT* CMENRF ONTRTFL PREFL SAFFL TRTA TRTAN TRTSDT* TRTEDT* AGE AGEGR1 SEX RACE
8 (cont) 01Jun2011 Y Y Drug B 2 10MAY2011 25NOV2011 54 <65 M ASIAN
9 (cont) ONGOING Y Y Drug B 2 10MAY2011 25NOV2011 54 <65 M ASIAN
10 (cont) ONGOING Y Y Y Drug A 1 16JUN2011 03JAN2012 54 <65 M ASIAN
10 Example 7: Analysis of Medical History Mapped to MedDRA

The basic summary of medical history frequencies described in section 12.2.2 (and located in section 14.3.1) of ICH Guideline E3 [12] report should be used to
display frequencies in treatment and control groups.
This example displays a simple summary of all spontaneously reported medical history. The example is based on a two treatment parallel design study. The
display summarizes (1) the number of subjects in each treatment group who had a given medical history event and (2) the rate of occurrence in each treatment
group.

Table 10.1.1 Example of Summary of Medical History*
Summary of General Medical History Events
Safety Population
HISTORY CATEGORY Active Drug Placebo Total
Body System (N=4) (N=5) (N=9)
Event
Any Medical History 3 (75.0%) 3 (60.0%) 6 (66.7%)
GASTROINTESTINAL 1 (25.0%) 0 1 (11.1%)
Gastrointestinal disorders 1 (25.0%) 0 1 (11.1%)
Abdominal pain 1 (25.0%) 0 1 (11.1%)
Gastroesophageal reflux disease 1 (25.0%) 0 1 (11.1%)
Nausea 1 (25.0%) 0 1 (11.1%)
HEMATOLOGICAL/LYMPHATIC 1 (25.0%) 0 1 (11.1%)
Blood and lymphatic system disorders 1 (25.0%) 0 1 (11.1%)
Anaemia 1 (25.0%) 0 1 (11.1%)
RESPIRATORY 3 (75.0%) 3 (60.0%) 6 (66.7%)
Immune system disorders 2 (50.0%) 3 (60.0%) 5 (55.6%)
Seasonal allergy 2 (50.0%) 3 (60.0%) 5 (55.6%)
Infections and infestations 1 (25.0%) 2 (40.0%) 3 (33.3%)
Upper respiratory tract infection 1 (25.0%) 2 (40.0%) 3 (33.3%)
Respiratory, thoracic and mediastinal disorders 1 (25.0%) 3 (60.0%) 4 (44.4%)
Asthma 1 (25.0%) 0 1 (11.1%)
Dyspnoea 0 3 (60.0%) 3 (33.3%)
The count and percent of unique subjects per classification group may be based on any of the classification variables. In this table, the count and percent of
unique subjects is summarized by the variables MHSCAT, MHBODSYS, and MHDECOD. The table also summarizes the number of subjects who had any
medical history event (e.g. the row ‘Any Medical History’). The denominator counts (shown here in the (N=) in the column headings) are taken from the ADSL
dataset and are based on the count of subjects in the population in the population of interest. Note that not all subjects in the population of interest will necessarily
have data in the medical history file.
This presentation is analogous to the logic typically used for Adverse Events summaries.

This example describes an adverse events ADaM dataset named ADMH. ADMH is not a required dataset name.

Dataset Codelist /
Variable Name Variable Label Variable Type Source / Derivation
ADCM STUDYID Study Identifier text MH.STUDYID
ADMH USUBJID Unique Subject Identifier text MH.USUBJID
ADMH MHSEQ Sequence Number integer MH.MHSEQ
ADMH MHCAT Category for Medical History text MH.MHCAT
ADMH MHSCAT Sub Category for Medical History text MH.MHSCAT
ADMH MHDECOD Dictionary-Derived Term text MH.MHDECOD
ADMH MHBODSYS Body System or Organ Class text MH.MHBODSYS
ADMH MHTERM Reported Term for the Medical History text MH.MHTERM
ADMH MHSTDTC Start Date/Time of Medication datetime ISO 8601 MH.MHSTDTC
ADMH ASTDT Analysis Start Date integer From MH.MHSTDTC, converted to SAS Date. Any derivations to
derive partial start dates are applied here and listed in comments.
ADMH ASTTM Analysis Start Time integer From MH.MHSTDTC, converted to SAS Time.
ADMH ASTDTM Analysis Start Date/Time integer From MH.MHSTDTC, converted to SAS Datetime.
ADMH MHENDTC End Date/Time of Medication datetime ISO 8601 MH.MHENDTC
ADMH AENDT Analysis End Date integer From MH.MHENDTC, converted to SAS Date. Any derivations to
derive partial start dates are applied here and listed in comments.
ADMH AENTM Analysis End Time integer From MH.MHENDTC, converted to SAS Time.
ADMH AENDTM Analysis End Date/Time integer From MH.MHENDTC, converter to SAS Datetime.
ADMH MHENRF End Relative to Reference Period text MH.MHENRF

Table 10.3.1 is an illustration of the Medical History analysis dataset (ADMH) defined above. The ADMH dataset illustrated in this example was designed to
support some standard subsets and/or classifications of Medical Histories. The example describes key variables and records that would be included in the dataset.
The example data are assumed to be gathered on a case report form that contains a set of defined categories. A subject may or may not have had any significant
medical history in any of the categories on the form. There is a record in the medical history file for each symptom or condition listed on the form; subjects with
no recorded medical history may not appear in this file. The MHCAT variable indicates the type of CRF page the data were gathered on, and MHSCAT indicates
the CRF category. MHTERM is the symptom term that was recorded; MHDECOD and MHBODSYS are taken from matching the text in MHTERM with a
coding dictionary (in this case MedDRA). The date variables indicate the beginning and end timing of the medical history event.

1. Variables such as MHSTDTC and MHENDTC are copied in from SDTM MH domain to provide data point traceability.
2. Variables such as MHSCAT, MHDECOD, and MHBODSYS are copied in from the SDTM MH domain for analysis purposes.
3. ASTDT and AENDT are the timing variables used for analysis. Another timing variable MHENRF is a supportive variable for metadata traceability.
4. This is a simple example to only illustrate variables that are relevant to ADMH. It does not include all variables that could be needed for analysis or all
indicated in metadata in table 10.2.1. For example, it does not include variables like severity of the History event.
5. For this analysis, the subject level treatment variable (TRT01A or TRT01P, not shown) would be appropriate. Record-level treatment variables would
not be needed since the data are gathered prior to start of study treatment.
6. The TRTEMFL (treatment emergent flag), ONTRTFL (on-treatment flag), FUPFL (follow-up flag) and PREFL (pre-treatment flag) are not included in
this analysis file because this dataset will only be used for baseline summaries. (Note that these variables could be defined if there was an analysis
purpose that called for them). Similarly, the Occurrence Flags are permissible but not required unless needed for a specific analysis purpose.
7. Core variables (such as AGE, RACE, and SEX) would typically be added to the dataset but are not shown in this example.
Table 10.3.1 Sample Medical History Data for Spontaneously Reported Events
Row USUBJID MHTERM MHDECOD MHBODSYS MHCAT MHSCAT MHSTDTC* ASTDT* MHENDTC* AENDT* MHENRF
Blood and lymphatic system MEDICAL HEMATOLOGICAL/
1 ABC-001 ANEMIA Anaemia 2010-02-01 01FEB2010 ONGOING
disorders HISTORY LYMPHATIC
Gastroesophageal MEDICAL
2 ABC-001 GERD Gastrointestinal disorders GASTROINTESTINAL 2011-01-04 04JAN2011 2011-01-04 04JAN2011
reflux disease HISTORY
MEDICAL
3 ABC-001 NAUSEA Nausea Gastrointestinal disorders GASTROINTESTINAL 2011-01-10 10JAN2011 2011-01-10 10JAN2011
HISTORY
SPLEEN MEDICAL
4 ABC-001 Abdominal pain Gastrointestinal disorders GASTROINTESTINAL 2011-01-15 15JAN2011 2011-01-15 15JAN2011
PAIN HISTORY
Respiratory, thoracic and MEDICAL
5 ABC-001 ASTHMA Asthma RESPIRATORY 2011-01-17 17JAN2011 2011-01-17 17JAN2011
mediastinal disorders HISTORY
SEASONAL MEDICAL
6 ABC-002 Seasonal allergy Immune system disorders RESPIRATORY 2011-05-14 14MAY2011 2011-06-01 01JUN2011
ALLERGIES HISTORY
numeric date formats can be used, but care should be taken with newer date formats which might not be understood by all statistical packages.
11 Example 8: Analysis of Medical History Pre-specified Events

In the example data shown below, the data are gathered on a case report form that contains a pre-specified category (in this case diabetes history), including a
checkbox to indicate whether or not the subject had this condition. Diabetes history is not coded.
Analysis of the number of subjects with and without pre-specified events is an option for medical history. This option does not have a counterpart in adverse
events analysis, because the AE domain does not allow for the collection of pre-specified events with AEOCCUR of N.

The data are analyzed here by counting the number of unique subjects per treatment group, MHCAT, MHTERM, and MHOCCUR. The values of MHOCCUR
are formatted from Y and N to more readable values (e.g., ‘Y=Reported History’) for presentation. For the examples below, we assume that the ADMH file is
merged with ADSL to ensure that all safety subjects are identified. However, there may be some safety subjects in ADSL who do not occur in ADMH. (This
situation can occur due to missing CRF data).
Table 11.1.1 Example of Summary of Medical History*

Summary of Diabetes History Events
Safety Population
Diabetes History Category Active Drug Placebo Total
(N=4) (N=4) (N=8)
DIABETES HISTORY
DIABETES MELLITUS[1]
N=No History 3 (75.0%) 2 (100.0%) 5 (83.3%)
Y=Reported History 1 (25.0%) 0 1 (16.7%)
Diabetes History Not Available[1] 0 2 2

[1] Population counts in the column header include all subjects in the safety population. Percentages are based on the
number of safety subjects in each treatment group for whom diabetes history data are available. The ‘No Reported
History’ counts are based on subjects with the ‘No’ box checked on Medical History CRF page xxx.
The choice of denominator will be based on statistical judgment and should be clearly described in the programming specifications. The choice of denominator
should also be clearly identified somewhere on the report (for instance, in the title or footnotes).
In the example above, we based the denominator on only the subjects in the population of interest who have records in ADMH with MHCAT = ‘DIABETES
HISTORY’.
An alternative analysis would be to base the denominator on the number of subjects in the population (typically defined by the number of subjects with
appropriate population flags in ADSL).
* The style of the display of the results of an analysis will be determined by the producer. The example is intended to illustrate content, not appearance.
Table 11.1.2 Alternate Example of Summary of Medical History*

Summary of Diabetes History Events
Safety Population
Diabetes History Category Active Drug Placebo Total
(N=4) (N=4) (N=8)
DIABETES HISTORY
DIABETES MELLITUS
N=No Reported History 3 (75.0%) 2 (50.0%) 5 (62.5%)
Y=Reported History 1 (25.0%) 0 (0.0%) 1 (12.5%)
Unknown[1] 0 (0.0%) 2 (50.0%) 2 (25.0%)
[1] Population counts in the column header include all subjects in the safety population. Percentages are based on the
number of safety subjects in each treatment group, whether they had diabetes history data or not. The ‘Unknown’
counts are based on subjects who did not have a Medical History CRF page xxx.

This example describes an adverse events ADaM dataset named ADMH. ADMH is not a required dataset name.
Table 11.2.1 Sample ADaM Variable Metadata

STUDYID Study Identifier text MH.STUDYID
USUBJID Unique Subject Identifier text MH.USUBJID
MHSEQ Sequence Number integer MH.MHSEQ
MHCAT Category for Medical History text MH.MHCAT
MHTERM Reported Term for the Medical History text MH.MHTERM
MHSTDTC Start Date/Time of Medical History Event datetime ISO8601 MH.MHSTDTC
ASTDT Analysis Start Date integer From MHSTDTC, converted to SAS Date. Any derivations to derive partial start dates
are applied here and listed in comments.
ASTTM Analysis Start Time integer From MH.MHSTDTC, converted to SAS Time.
ASTDTM Analysis Start Date/Time integer From MH.MHSTDTC, converted to SAS Datetime.
MHENDTC End Date/Time of Medical History Event datetime ISO8601 MH.MHENDTC
AENDT Analysis End Date integer From MHENDTC, converted to SAS Date. Any derivations to derive partial start dates
are applied here and listed in comments.
AENTM Analysis End Time integer From MHENDTC, converted to SAS Time.
AENDTM Analysis End Date/Time integer From MHENDTC, converted to SAS Datetime.
MHPRESP Medical History Event Pre-Specified text N,Y MH.MHPRESP
Is Med Hx event from pre-specified CRF page
* The style of the display of the results of an analysis will be determined by the producer. The example is intended to illustrate content, not appearance.

MHOCCUR Medical History Occurrence text N,Y MH.MHOCCUR
Did subject have the event, Y or N
MHENRTPT End Relative to Reference Time Point text ONGOING MH.MHENRTPT
MHENTPT End Reference Time Point text SCREENING MH.MHENTPT

Table 11.3.1 is an illustration of the Medical History (Pre-Specified Events) analysis dataset (ADMH) defined above. The ADMH dataset illustrated in this
example was designed to support some standard subsets and/or classifications of Medical Histories. The example describes key variables and records that would
be included in the dataset.

1. This is a simple example to only illustrate the ADMH Pre-Specified Events. It does not include all variables that could also be needed for analysis or all
indicated in Metadata.
2. The dataset is prepared to support analysis of pre-specified events by populating the variables MHCAT, MHTERM, MHPRESP, and MHOCCUR.
3. The MHCAT variable indicates the type of CRF page the data were gathered on, and MHPRESP is Y to indicate that the term is a pre-specified one.
MHOCCUR is either Y or N to indicate whether the subject did or did not have the event.
4. MHTERM is the symptom term. Since the MHTERM variable for pre-specified events will have a known and finite set of values, these values are used
here as a summarization category.
5. In this example, MHDECOD and MHBODSYS are not used. Instead MHCAT is used to categorize the data.
6. The date variables indicate the beginning and end timing of the medical history event (if any). It is null on records that do not indicate an event.
Table 11.3.1 Sample Medical History Data for Pre-specified Events

Row USUBJID MHSEQ MHTERM MHCAT MHPRESP MHOCCUR MHSTDTC* MHENDTC* MHENRTPT MHENTPT
1 ABC-001 6 DIABETES MELLITUS DIABETES HISTORY Y N
3 ABC-003 1 DIABETES MELLITUS DIABETES HISTORY Y Y 2001-03 ONGOING SCREENING
* Variables ending in suffix DTC are character date/time fields in the ISO8601 format.
Appendices
Appendix A: References
1. Analysis Data Model (ADaM) version 2.1

http://www.cdisc.org/adam
2. Analysis Data Model (ADaM) Implementation Guide version 1.1
http://www.cdisc.org/adam
3. Study Data Tabulation Model Implementation Guide (SDTMIG) V3.2 and the SDTM document V1.4
http://www.cdisc.org/sdtm
4. Medical Dictionary for Regulatory Activities (MedDRA)
http://www.meddramsso.com/
5. World Health Organization Adverse Reaction Terminology (WHO-ART)
http://www.umc-products.com/DynPage.aspx?id=73589&mn1=1107&mn2=1664
6. International Classification of Diseases (ICD)
http://www.who.int/classifications/icd/en/
7. Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)
http://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/CST/
Note: This coding system has been replaced by MedDRA at US FDA.
8. International Conference of Harmonization E2A “Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting”
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guide
line.pdf
9. International Conference of Harmonization E9 “Statistical Principles for Clinical Trials”
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline
.pdf
10. National Cancer Institute Common Toxicity (NCI CTC) version 4.03
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14.xls
11. CDISC Define-XML Specification 2.0
http://www.cdisc.org/define-xml
12. International Conference of Harmonization E3 “Structure and Content of Clinical Study Reports”
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/Step4/E3_Guideline
.pdf
13. Standardised MedDRA Queries (SMQs)
http://www.meddramsso.com/subscriber_smq.asp
14. CDISC Analysis Results Metadata Specification Version 1.0 for Define-XML Version 2
http://www.cdisc.org/
15. The National Center for Biomedical Ontology Bioportal
http://bioportal.bioontology.org/ontologies/MEDDRA?p=classes&conceptid=root
Appendix B: Revision History

This section lists all changes in the OCCDS document from Provisional version 1.0 to Final version 1.0.
Category/Section Type Description

Removed the word “Record” from the label of variable ANLzzFL to
Section 3.2.5 Indicator Variables Update
make it consistent with ADaMIG v1.1.
Appendix C: Representations and Warranties, Limitations of

Liability, and Disclaimers
CDISC Patent Disclaimers

It is possible that implementation of and compliance with this standard may require use of subject matter covered by
patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any
claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be
responsible for identifying patent claims for which a license may be required in order to implement this standard or
for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its
attention.
Representations and Warranties

“CDISC grants open public use of this User Guide (or Final Standards) under CDISC’s copyright.”
Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time
of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it
holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in
which it holds relevant intellectual property rights; (b) there are no limits to the Participant’s ability to make the
grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft
Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional
restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such
Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in
source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of
the CDISC Intellectual Property Policy (“the Policy”)); or (iii) distributed at no charge, except as set forth in
Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or
any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in
part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the
same to the CDISC President who shall promptly notify all Participants.
No Other Warranties/Disclaimers. ALL PARTICIPANTS ACKNOWLEDGE THAT, EXCEPT AS PROVIDED

UNDER SECTION 9.3 OF THE CDISC INTELLECTUAL PROPERTY POLICY, ALL DRAFT STANDARDS
AND FINAL STANDARDS, AND ALL CONTRIBUTIONS TO FINAL STANDARDS AND DRAFT
STANDARDS, ARE PROVIDED “AS IS” WITH NO WARRANTIES WHATSOEVER, WHETHER EXPRESS,
IMPLIED, STATUTORY, OR OTHERWISE, AND THE PARTICIPANTS, REPRESENTATIVES, THE CDISC
PRESIDENT, THE CDISC BOARD OF DIRECTORS, AND CDISC EXPRESSLY DISCLAIM ANY
WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR ANY PARTICULAR OR
INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF ANY PROPOSAL,
FINAL STANDARDS OR DRAFT STANDARDS, OR CONTRIBUTION.
Limitation of Liability
IN NO EVENT WILL CDISC OR ANY OF ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED
TO, THE CDISC BOARD OF DIRECTORS, THE CDISC PRESIDENT, CDISC STAFF, AND CDISC
MEMBERS) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY LOSS OF PROFITS, LOSS OF
USE, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER
UNDER CONTRACT, TORT, WARRANTY, OR OTHERWISE, ARISING IN ANY WAY OUT OF THIS
POLICY OR ANY RELATED AGREEMENT, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE
OF THE POSSIBILITY OF SUCH DAMAGES.
Note: The CDISC Intellectual Property Policy can be found at

http://www.cdisc.org/system/files/all/article/application/pdf/cdisc_20ip_20policy_final.pdf.

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ADaM Structure for Occurrence Data

Date Version Summary of Changes

2 DATA ANALYSIS AND CODING...................................................................................... 6

3 ADAM METADATA ............................................................................................................ 9

4 EXAMPLE 1: ANALYSIS OF TREATMENT EMERGENT ADVERSE EVENT ..... 22

5 EXAMPLE 2: ANALYSIS OF HEMORRHAGES (SMQ) AMONG TREATMENT

6 EXAMPLE 3: ANALYSIS OF PERIPHERAL SENSORY NEUROPATHY (PSN)

7 EXAMPLE 4: ANALYSIS OF TREATMENT EMERGENT ADVERSE EVENTS IN

7.3 SAMPLE ADAM DATA......................................................................................................................................... 35

8 EXAMPLE 5: MEDDRA SECONDARY PATH ............................................................. 37

9 EXAMPLE 6: ANALYSIS OF CONCOMITANT MEDICATIONS............................. 40

10 EXAMPLE 7: ANALYSIS OF MEDICAL HISTORY MAPPED TO MEDDRA ....... 44

11 EXAMPLE 8: ANALYSIS OF MEDICAL HISTORY PRE-SPECIFIED EVENTS... 47

The table shows a summary of differences between the two documents:

Table 1.1.1: Differences between Data Structures

1.2 Points to Consider When Interpreting this Document

1.3 Conventions Used in this Document

2 Data Analysis and Coding

2.2 Dictionary Coding

2.2.1 Recoding of Occurrence Data

2.3 Adverse Events

2.4 Concomitant Medications Data

2.5 Pre-specified Data

2.6 Combining Spontaneous and Pre-specified Occurrences

2.7 Other Data

3.1 Dataset Metadata

Table 3.1.1 Example of ADaM OCCDS Dataset Metadata*,

3.2 ADaM Variables and Variable Metadata

3.2.1 ADSL Variables

3.2.2 Identifier Variables

Table 3.2.2.1 OCCDS Identifier Variables

3.2.3 Dictionary Coding and Categorization Variables

Common Dictionary Coding Variables for MedDRA

Table 3.2.3.1 MedDRA Dictionary Coding Variables

Common Dictionary Coding Variables for WHO Drug

Table 3.2.3.2 WHO Drug Dictionary Coding Variables

Other Categorization Variables

Table 3.2.3.3 Other Categorization Variables

3.2.4 Timing Variables

Table 3.2.4.1 Timing Variables

3.2.5 Indicator Variables

Table 3.2.5.1 SDTM Indicator Variables

Table 3.2.5.2 OCCDS Indicator Variables

Table 3.2.5.3 Adverse Events Indicator Variables

Table 3.2.5.4 Concomitant Medications Indicator Variables

Table 3.2.5.5 Adverse Events and Concomitant Medications Indicator Variables

3.2.6 Occurrence Flag Variables

Table 3.2.6.1 OCCDS Occurrence Flag Variables

Table 3.2.6.2 MedDRA Occurrence Flag Variables

3.2.7 Treatment/Dose Variables

Table 3.2.7.1 Treatment/Dose Variables

3.2.8 Descriptive Variables

Table 3.2.8.1 Adverse Event Descriptive Variables

Table 3.2.8.2 Concomitant Medications Descriptive Variables

3.2.9 Standardized MedDRA Query Variables

Table 3.2.9.1 Standardized MedDRA Query Variables

3.2.10 Original or Prior Coding Variables

Table 3.2.10.1 Original or Prior MedDRA Coding Variables

Table 3.2.10.2 Original or Prior WHO Drug Coding Variables