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RequestRelated JIRA IssuesStatusFixed/Updated/Removed from SDTMIG v4.0?
Updated IS example 11 in IG3.4

Status
colourGreen
titleResolved

Status
colourGreen
titleupdate complete

2023-03-06: This example has been updated in IG4.0 by Jordan. SuppIS has been converted to NSIS per SDS request. Also, verified with Diane W, the use of "Multiple" rule here is not appropriate here, concatenated values are fine in ISBTAR.

Below is the updated version of the IS Example 11

IS Example 11 in the SDTMIG 3.4 needs to be updated to cix SuppIS dataset.

Related JIRA issues: SDS-2553; SDS-2563

Discussion with Richard Marshall: https://wiki.cdisc.org/x/-otLCQ

Suggested changes:

  • change IDVAR to ISSEQ in both suppIS datasets.
  • change QNAM and QLBEL to ABTR and Antibody Target
    • change QVAL to Dog Dander Antigen, Cat Dander Antigen, Horse Dander Antigen, Cow Dander Antigen

    .

    Dataset wrap
    titlelb.xpt
    Nameis
    Rowcaps
    Row 1:Shows the detection of immunoglobulin E (IgE) antibody against multiple animal allergens.
    Rows 2-3:Show the amount of IgE antibody against dog dander and its RAST classification score.
    Rows 4-5:Show the amount of IgE antibody against cat dander and its RAST classification score.

    Rows 6-7:

    		Show the amount of IgE antibody against horse dander and its RAST classification score.
    Rows 8-9:Show the amount of IgE antibody against cow dander and its RAST classification score.
    Row 10:Shows immunoglobulin E (IgE) antibody against multiple tree pollen allergens is not detected.
    Dataset2
    RowSTUDYIDDOMAINUSUBJIDISSEQISGRPIDISREFIDISTESTCDISTESTISBDAGNTISTSTDTLISORRESISORRESUISSTRESCISSTRESNISSTRESUISSPECISMETHODVISITNUMVISITISDTC
    1XYZISXYZ12341112453333ARIGEABAllergen-induced IgE AntibodyANIMAL MIX ANTIGENS
    		POSITIVE
    		POSITIVE

    		SERUMRIA1SCREENING2018-06-20
    2XYZISXYZ12342212456666ARIGEABAllergen-induced IgE Antibody

    DOG DANDER ANTIGEN


    		0.12U/mL0.120.12U/mLSERUMRIA1SCREENING2018-06-20
    3XYZISXYZ12343212456666ARIGEABAllergen-induced IgE Antibody

    DOG DANDER ANTIGEN

    		RAST SCORE0
    		00
    		SERUMRIA1SCREENING2018-06-20
    4XYZISXYZ12344312456666ARIGEABAllergen-induced IgE Antibody

    CAT DANDER ANTIGEN


    		0.19U/mL0.190.19U/mLSERUMRIA1SCREENING2018-06-20
    5XYZISXYZ12345312456666ARIGEABAllergen-induced IgE Antibody

    CAT DANDER ANTIGEN

    		RAST SCORE0
    		00
    		SERUMRIA1SCREENING2018-06-20
    6XYZISXYZ12346412456666ARIGEABAllergen-induced IgE AntibodyCOW DANDER ANTIGEN
    		44U/mL4444U/mLSERUMRIA1SCREENING2018-06-20
    7XYZISXYZ12347412456666ARIGEABAllergen-induced IgE AntibodyCOW DANDER ANTIGENRAST SCORE4
    		44
    		SERUMRIA1SCREENING2018-06-20
    8XYZISXYZ12348512456666ARIGEABAllergen-induced IgE AntibodyHORSE DANDER ANTIGEN
    		120U/mL120120U/mLSERUMRIA1SCREENING2018-06-20
    9XYZISXYZ12349512456666ARIGEABAllergen-induced IgE AntibodyHORSE DANDER ANTIGENRAST SCORE6
    		66
    		SERUMRIA1SCREENING2018-06-20
    10XYZISXYZ123410
    		12458888ARIGEABAllergen-induced IgE AntibodyTREE MIX POLLENS
    		NEGATIVE
    		NEGATIVE

    		SERUMRIA1SCREENING2018-06-20

    The NSIS dataset below shows the specific and individual animal and tree pollen allergens within the mixed antigens panel tests. Users may wonder why the SDTM "MULTIPLE" convention is not used in the records below, this is because the tests are not "check/select some or all that apply" scenario. The allergen panel tests look for antibodies that target multiple allergens in the below dataset all at the same time and in a single analysis, and the outcome of the assessment is a pooled positive or negative result (IS dataset above rows 1 and 10). Therefore, all the targeted allergens are mapped to ISABTR and are separated with a semicolon.

    ISABTR1
    Dataset wrap
    titlelb.xpt
    Namesuppisnsis
    Dataset2
    RowSTUDYID
    DOMAIN
    RDOMAINUSUBJIDIDVARIDVARVAL
    		QNAMQLABELQVALQORIGQEVAL
    ISABTR
    1XYZISXYZ1234ISSEQ
    		1ISABTRAntibody TargetMULTIPLECRF2XYZISXYZ1234ISSEQ1
    Antibody Target
    1DOG DANDER ANTIGEN
    CRF3XYZISXYZ1234ISSEQ1ISABTR2Antibody Target 2CAT DANDER ANTIGENCRF4XYZISXYZ1234ISSEQ1ISABTR3Antibody Target 3HORSE DANDER ANTIGENCRF5XYZISXYZ1234ISSEQ1ISABTR4Antibody Target 4
    ; CAT DANDER ANTIGEN; HORSE DANDER ANTIGEN; COW DANDER ANTIGEN
    CRF
    6
    XYZISXYZ1234ISSEQ10ISABTRAntibody TargetMULTIPLECRF
    7
    XYZISXYZ1234ISSEQ10
    ISABTR1
    Antibody Target 1
    BOX ELDER POLLEN
    CRF8XYZISXYZ1234ISSEQ10ISABTR2Antibody Target 2OLIVE TREE POLLENCRF9XYZISXYZ1234ISSEQ10ISABTR3Antibody Target 3SILVER BIRCH POLLENCRF
    ; OLIVE TREE POLLEN; SILVER BIRCH POLLEN
    Dataset wrap
    titlelb.xpt
    Namensis
    Definexmltable
    DatasetNSIS
    NameISABTRG
    VariableLabelTypeCodelistRole
    ISABTRGAntibody TargetChar
    		Non-Standard Qualifier

    Alternatively, instead of reporting the specific components of a mixed allergen panel, regional allergen mixes may also be reported by the specific regions/areas where they are predominant, as shown in the NSIS dataset below.

    Dataset wrap
    titlelb.xpt
    Namesuppisnsis
    Dataset2
    RowSTUDYID
    DOMAIN
    RDOMAINUSUBJIDIDVARIDVARVAL
    		QNAMQLABELQVALQORIGQEVAL
    ISALGREG
    1XYZISXYZ1234ISSEQ1
    		ISALGREGAllergen Mixture Region
    CENTRAL CA, AREA 14
    CRF
    2XYZISXYZ1234ISSEQ10SOUTHERN FL, AREA 3
    Dataset wrap
    titlelb.xpt
    Namensis
    CRF
    Definexmltable
    DatasetNSIS
    NameISALGREG
    VariableLabelTypeCodelistRole
    ISALGREGAllergen Mixture Region
    		SOUTHERN FL, AREA 3
    Char
    		Non-Standard Qualifier