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Fixed/Updated/Removed from SDTMIG v4.0?

Updated IS example 11 in IG3.4

Status

colour	Green
title	Resolved

Status


colour	Green
title	update 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

Dataset wrap

title	lb.xpt
Name	is

Rowcaps

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.
Row 10:	Shows immunoglobulin E (IgE) antibody against multiple tree pollen allergens is not detected.

1

Dataset2
Dataset2

Row	STUDYID	DOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL

Row	STUDYID	DOMAIN	USUBJID	ISSEQ	ISGRPID	ISREFID	ISTESTCD	ISTEST	ISBDAGNT	ISTSTDTL	ISORRES	ISORRESU	ISSTRESC	ISSTRESN	ISSTRESU	ISSPEC	ISMETHOD	VISITNUM	VISIT	ISDTC
1	XYZ	IS	XYZ1234	1	1	12453333	ARIGEAB	Allergen-induced IgE Antibody	ANIMAL MIX ANTIGENS		POSITIVE		POSITIVE			SERUM	RIA	1	SCREENING	2018-06-20
2	XYZ	IS	XYZ1234	2	2	12456666	ARIGEAB	Allergen-induced IgE Antibody	DOG DANDER ANTIGEN		0.12	U/mL	0.12	0.12	U/mL	SERUM	RIA	1	SCREENING	2018-06-20
3	XYZ	IS	XYZ1234	3	2	12456666	ARIGEAB	Allergen-induced IgE Antibody	DOG DANDER ANTIGEN	RAST SCORE	0		0	0		SERUM	RIA	1	SCREENING	2018-06-20
4	XYZ	IS	XYZ1234	4	3	12456666	ARIGEAB	Allergen-induced IgE Antibody	CAT DANDER ANTIGEN		0.19	U/mL	0.19	0.19	U/mL	SERUM	RIA	1	SCREENING	2018-06-20
5	XYZ	IS	XYZ1234	5	3	12456666	ARIGEAB	Allergen-induced IgE Antibody	CAT DANDER ANTIGEN	RAST SCORE	0		0	0		SERUM	RIA	1	SCREENING	2018-06-20
6	XYZ	IS	XYZ1234	6	4	12456666	ARIGEAB	Allergen-induced IgE Antibody	COW DANDER ANTIGEN		44	U/mL	44	44	U/mL	SERUM	RIA	1	SCREENING	2018-06-20
7	XYZ	IS	XYZ1234	7	4	12456666	ARIGEAB	Allergen-induced IgE Antibody	COW DANDER ANTIGEN	RAST SCORE	4		4	4		SERUM	RIA	1	SCREENING	2018-06-20
8	XYZ	IS	XYZ1234	8	5	12456666	ARIGEAB	Allergen-induced IgE Antibody	HORSE DANDER ANTIGEN		120	U/mL	120	120	U/mL	SERUM	RIA	1	SCREENING	2018-06-20
9	XYZ	IS	XYZ1234	9	5	12456666	ARIGEAB	Allergen-induced IgE Antibody	HORSE DANDER ANTIGEN	RAST SCORE	6		6	6		SERUM	RIA	1	SCREENING	2018-06-20

Dataset wrap

title	lb.xpt
Name	suppis

10	XYZ	IS	XYZ1234

ISSEQ

10

1

12458888

ISTARAG

Target Antigen

MULTIPLE

CRF

2

XYZ

IS

XYZ1234

ISSEQ

1

ISTARAG1

Target Antigen 1

DOG DANDER

CRF

3

XYZ

IS

XYZ1234

ISSEQ

1

ISTARAG2

Target Antigen 2

CAT DANDER

CRF

4

XYZ

IS

XYZ1234

ISSEQ

1

ISTARAG3

Target Antigen 3

HORSE DANDER

CRF

5

XYZ

IS

XYZ1234

ISSEQ

1

ISTARAG4

Target Antigen 4

COW DANDER

CRF

Dataset wrap

title	lb.xpt
Name	suppis

Dataset2RowSTUDYIDDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL1XYZISXYZ1234ISSEQ1ISALGREGAllergen Mixture RegionCENTRAL CA, AREA 14CRF

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

ARIGEAB

Allergen-induced IgE Antibody

TREE MIX POLLENS

NEGATIVE

SERUM

RIA

1

SCREENING

2018-06-20

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.

ARIGEAB

Dataset wrap

title	lb.xpt
Name	is	nsis

Rowcaps

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.

Dataset2

Row	STUDYID

DOMAIN

RDOMAIN	USUBJID

ISSEQ

IDVAR

ISGRPID

ISREFID

ISTESTCD

ISTEST

ISBDAGNT

ISTSTDTL

ISORRES

ISORRESU

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

VISITNUM

VISIT

ISDTC

IDVARVAL	ISABTR
1	XYZ	IS	XYZ1234

1

ISSEQ

1

12453333

Allergen-induced IgE AntibodyANIMAL MIX ANTIGENS, MULTIPLEPOSITIVEPOSITIVESERUMRIA1SCREENING2018-06-202XYZISXYZ12342212456666ARIGEABAllergen-induced IgE Antibody

DOG DANDER ANTIGEN

0.12U/mL0.120.12U/mLSERUMRIA1SCREENING2018-06-203XYZISXYZ12343212456666ARIGEABAllergen-induced IgE Antibody

DOG DANDER ANTIGEN

RAST SCORE000SERUMRIA1SCREENING2018-06-204XYZISXYZ12344312456666ARIGEABAllergen-induced IgE Antibody

CAT DANDER ANTIGEN

0.19U/mL0.190.19U/mLSERUMRIA1SCREENING2018-06-205XYZISXYZ12345312456666ARIGEABAllergen-induced IgE Antibody

CAT DANDER ANTIGEN

RAST SCORE000SERUMRIA1SCREENING2018-06-20

DOG DANDER ANTIGEN; CAT DANDER ANTIGEN; HORSE DANDER ANTIGEN; COW DANDER ANTIGEN

6	XYZ	IS	XYZ1234

6

ISSEQ

412456666ARIGEABAllergen-induced IgE AntibodyCOW DANDER ANTIGEN44U/mL4444U/mLSERUMRIA1SCREENING2018-06-207XYZISXYZ12347412456666ARIGEABAllergen-induced IgE AntibodyCOW DANDER ANTIGENRAST SCORE444SERUMRIA1SCREENING2018-06-208XYZISXYZ12348512456666ARIGEABAllergen-induced IgE AntibodyHORSE DANDER ANTIGEN120U/mL120120U/mLSERUMRIA1SCREENING2018-06-209XYZISXYZ12349512456666ARIGEABAllergen-induced IgE AntibodyHORSE DANDER ANTIGENRAST SCORE666SERUMRIA1SCREENING2018-06-20

10	BOX ELDER POLLEN; OLIVE TREE POLLEN; SILVER BIRCH POLLEN

Dataset wrap

title	lb.xpt
Name	nsis

Definexmltable

Dataset	NSIS
Name	ISABTRG

Variable	Label	Type	Codelist	Role
ISABTRG	Antibody Target	Char		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

title	lb.xpt
Name	nsis

QEVAL

Dataset2

Row	STUDYID

DOMAIN

RDOMAIN	USUBJID	IDVAR	IDVARVAL

QNAM

QLABEL

QVAL

QORIG

ISALGREG
1	XYZ	IS	XYZ1234	ISSEQ	1

ISBDAG1

Binding Agent 1

DOG

CRF

CENTRAL CA, AREA 14
2	XYZ	IS	XYZ1234	ISSEQ

1ISBDAG2Binding Agent 2CATCRF3XYZISXYZ1234ISSEQ1ISBDAG3Binding Agent 3HORSECRF4XYZISXYZ1234ISSEQ1ISBDAG4Binding Agent 4COWCRF

10	SOUTHERN FL, AREA 3

Dataset wrap

title	lb.xpt
Name	nsis

Definexmltable

Dataset	NSIS
Name	ISALGREG

Variable	Label	Type	Codelist	Role
ISALGREG	Allergen Mixture Region	Char		Non-Standard Qualifier

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