Updates to IS Example 11 (Fix Version: SDTMIG 4.0)

Request	Related JIRA Issues	Status	Fixed/Updated/Removed from SDTMIG v4.0?
Updated IS example 11 in IG3.4	SDS-2576 SDS-2575 SDS-2563 SDS-2553	RESOLVED	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.

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.

is.xpt

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
10	XYZ	IS	XYZ1234	10		12458888	ARIGEAB	Allergen-induced IgE Antibody	TREE MIX POLLENS		NEGATIVE		NEGATIVE			SERUM	RIA	1	SCREENING	2018-06-20

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

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nsis.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	ISABTR
1	XYZ	IS	XYZ1234	ISSEQ	1	DOG DANDER ANTIGEN; CAT DANDER ANTIGEN; HORSE DANDER ANTIGEN; COW DANDER ANTIGEN
6	XYZ	IS	XYZ1234	ISSEQ	10	BOX ELDER POLLEN; OLIVE TREE POLLEN; SILVER BIRCH POLLEN

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NSIS Variable Metadata [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.

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nsis.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	ISALGREG
1	XYZ	IS	XYZ1234	ISSEQ	1	CENTRAL CA, AREA 14
2	XYZ	IS	XYZ1234	ISSEQ	10	SOUTHERN FL, AREA 3

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NSIS Variable Metadata [ISALGREG]

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

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