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

Related JIRA issues: SDS-2553SDS-2563

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

Suggested changes:

  1. change IDVAR to ISSEQ in both suppIS datasets.
  2. change QNAM and QLBEL if need be, discuss with team, but suppIS row 1 should be QNAM = "MULTIPLE" followed by QNAM = XXXXXX1-4.
  3. change QVAL to Dog Dander, Cat Dander, Horse Dander, Cow Dander


Row 1:Shows the detection of immunoglobulin E (IgE) antibody against multiple animal allergens. ISBDAGNT is used to house the generic but controlled value "ANIMAL MIX ANTIGENS".
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.
$titleHtml

is.xpt

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
10


10


Allergen-induced IgE AntibodyTREE MIX POLLENS
NEGATIVE








Dataset Debug Message

There seem to be multiple domains (IS, <br/>) present in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

is.xpt

suppis.xpt

RowSTUDYIDDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1XYZISXYZ1234ISSEQ1ISABTRAntibody TargetMULTIPLECRF
2XYZISXYZ1234ISSEQ1ISABTR1Antibody Target 1DOG DANDER ANTIGENCRF
3XYZISXYZ1234ISSEQ1ISABTR2Antibody Target 2CAT DANDER ANTIGENCRF
4XYZISXYZ1234ISSEQ1ISABTR3Antibody Target 3HORSE DANDER ANTIGENCRF
5XYZISXYZ1234ISSEQ1ISABTR4Antibody Target 4COW DANDER ANTIGENCRF
6XYZISXYZ1234ISSEQ10ISABTRAntibody TargetMULTIPLECRF
7XYZISXYZ1234ISSEQ10ISABTR1Antibody Target 1Olive Tree pollenCRF
8XYZISXYZ1234ISSEQ10ISABTR2Antibody Target 2Mango Tree pollenCRF
9XYZISXYZ1234ISSEQ10ISABTR3Antibody Target 3Silver Birch Tree PollenCRF
$warningHtml

is.xpt

suppis.xpt

RowSTUDYIDDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1XYZISXYZ1234ISSEQ1ISALGREGAllergen Mixture RegionCENTRAL CA, AREA 14CRF
2XYZISXYZ1234ISSEQ10ISALGREGAllergen Mixture RegionCENTRAL FL, AREA 50CRF
$warningHtml

Richard's comments were that if you were to use the "MULTIPLE" convention in IS row 1 as appeared in the original example, ISBDAGNT= ANIMAL MIX ANTIGENS, MULTIPLE, then the suppIS dataset was created incorrectly. "MULTIPLE" requires QNAM to be xxx1-4. So if we want to keep the "MULTIPLE" in binding agent IS row 1, QNAM must be ISBDAG1-4.

However since the panel allergy results can also be reported by the region (as regional mixes), this ISBDAGNT= ANIMAL MIX ANTIGENS, MULTIPLE, doesn't make sense because this also implies multiple regions are associated with a single record, when in fact the IS row 1 record only indicates one region. So it is best to take the word "MULTIPLE" out of ISBDAGNT IS row 1.

Lastly, it seems odd to have dog, cat, horse, cow in QVAL because the panel antibody test targets dog dander, cat dander, horse dander, cow dander. QVAL values are imprecise and should be updated.

Row 1:Shows the detection of immunoglobulin E (IgE) antibody against multiple animal allergens. ISBDAGNT is used to house the generic but controlled value "ANIMAL MIX ANTIGENS".
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.

is.xpt

is.xpt

RowSTUDYIDDOMAINUSUBJIDISSEQISGRPIDISREFIDISTESTCDISTESTISBDAGNTISTSTDTLISORRESISORRESUISSTRESCISSTRESNISSTRESUISSPECISMETHODVISITNUMVISITISDTC
1XYZISXYZ12341112453333ARIGEABAllergen-induced IgE AntibodyANIMAL MIX ANTIGENS, MULTIPLE
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
$warningHtml



Dataset Wrapper Debug Message

Please add a row column to your dataset.

is.xpt

suppis.xpt

RowSTUDYIDDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1XYZISXYZ1234ISSEQ1ISBDAG1Binding Agent 1DOGCRF
2XYZISXYZ1234ISSEQ1ISBDAG2Binding Agent 2CATCRF
3XYZISXYZ1234ISSEQ1ISBDAG3Binding Agent 3HORSECRF
4XYZISXYZ1234ISSEQ1ISBDAG4Binding Agent 4COWCRF
$warningHtml

is.xpt

suppis.xpt

RowSTUDYIDDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1XYZISXYZ1234ISSEQ1ISALGREGAllergen Mixture RegionCENTRAL CA, AREA 14CRF
$warningHtml

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