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 Name | Variable Label | Type | Codelista | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
--OCCUR | XX Occurrence | Char | (NY) | Cond | Not used | 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 | 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 | SubClass ADVERSE EVENT Core | CDISC Notes |
ANLzzFL | Analysis Flag zz | Char | Y | Cond | 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 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 | Codelista | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
TRTEMFL | Product Emergent Analysis Flag | Char | Y | Cond | Req | 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 | 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 | 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 | Cond | Product-emergent flag from SDTM, if available. See SDTMIG v3.3, Appendix C2, Supplemental Qualifiers Name Codes, for more information. 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 | SubClass ADVERSE EVENT Core | CDISC Notes |
ONTRTFL | On Product Record Flag | Char | Y | Cond | Perm | 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 | 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 | 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 | SubClass ADVERSE EVENT Core | CDISC Notes |
PREFL | Pre-product Flag | Char | Y | Cond | 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 | 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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