Although some indicator variables can be copied from the SDTM, others are derived within ADaM. If indicator variables other than those shown in this section are included in the SDTM and pertinent for analysis, these should be copied to ADaM. Other indicator analysis variables that are needed for analysis can also be added.

SDTM Indicator Variables

Variable NameVariable LabelTypeCodelist/ Controlled TermsCoreCDISC Notes
--OCCURXX Occurrence

Char

(NY)

Cond

Copied from XX.--OCCUR

Conditional on whether this content is pertinent for analysis and is populated in SDTM

SDTM does not allow variable AEOCCUR, so this variable is not available to include in ADaM.

--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

OCCDS Indicator Variables

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

ANLzzFL

Analysis Flag zz

Char

Y

Cond

The ANLzzFL flag is useful in many circumstances; an example is when more than 1 coding path is 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. A codelist of Y, N, null may be used as described in  ADaMIG v1.2 Section 3.3.8, Indicator Variables for BDS Datasets.

This variable is conditional on whether analysis records flags are needed for analysis.

Adverse Events Indicator Variables

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

TRTEMFL

Product Emergent Analysis Flag

Char

Y

Cond

Product-emergent flag as defined for analysis Example derivation:

If ADSL.TRTSDT<=ASTDT<=ADSL.TRTEDT + x days then TRTEMFL="Y"

The number x in this derivation is defined by the producer and often incorporates the known half-life of the drug.

For datasets other than SubClass ADVERSE EVENT, this variable is conditional on whether the concept of product emergent is a key feature of the analysis.

TREMxxFL

Product Emergent Period xx Flag

Char

Y

Cond

This variable is required if there are multiple periods where product emergence is a key feature of the analysis for each period.

If TREMxxFL is included, TRTEMFL is defined as the overall product- emergent flag.

TRTEMwFL

Product Emergent Analysis w Flag

Char

Y

Perm

This variable is used if there are other analysis needs (e.g., different cut-offs) where product emergence is a key feature of the analysis.

If TREMwFL is included, TRTEMFL is defined as the overall product-emergent flag.

AETRTEM

Product Emergent Flag

Char

(NY)

Perm

Product-emergent flag from SDTM, if available.

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.

For SubClass ADVERSE EVENT, conditional on whether the AETRTEM variable is in the SDTM AE dataset and populated.

Concomitant Medications Indicator Variables

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

ONTRTFL

On Product Record Flag

Char

Y

Cond

Character indicator of whether the observation occurred while the subject was on product. A codelist of Y, N, null may be used as described in ADaMIG Section 3.3.8, Indicator Variables for BDS Datasets.

Example derivation:

If ADSL.TRTSDT <= ASTDT <= ADSL.TRTEDT then ONTRTFL = "Y"

This variable is conditional on whether the concept of on product is a feature of the study and used in analysis.

ONTRxxFL

On Product Period xx Flag

Char

Y

Perm

This variable is used if there are multiple periods where on product is a key feature of the analysis for each period.

If ONTRxxFL is included, ONTRTFL is defined as the overall on-product flag.

ONTRTwFL

On Product Record w Flag

Char

Y

Perm

This variable is used if there are other analysis needs (e.g., different cut-offs) where on product is a key feature of the analysis.

If ONTRTwFL is included, ONTRTFL is defined as the overall on-product flag.

Adverse Event and Concomitant Medications Indicator Variables

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

PREFL

Pre-product Flag

Char

Y

Cond

Character indicator of whether the observation occurred before the subject started product

Example derivation:

If ASTDT < ADSL.TRTSDT then PREFL="Y"

This variable is conditional on whether the concept of pre-product 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.

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Occurrence Flag Variables »

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