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There are a couple of JIRA issues that point out the errors in the suppIS datasets for IS Example 11 in the SDTMIG 3.4. Related JIRA issues: SDS-2553; SDS-2563

The MB/IS team, in response to the JIRA issues, will make the following updates to the IS Example 11.

Suggested changes:

-change IDVAR to ISSEQ in both suppIS datasets.
-change QNAM and QLBEL to ABTR and Antibody Target.
-use "MULTIPLE" for QNAM/QLABEL = ISABTR/Antibody Target
-add ISABTR1-4 and Antibody Target 1-4.
-change QVAL to Dog Dander Antigen, Cat Dander Antigen, Horse Dander Antigen, Cow Dander Antigen.

Affected Version: SDTMIG 3.4

Fix Version: SDTMIG 4.0

Dataset wrap

title	lb.xpt
Name	is

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

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

Dataset wrap

title	lb.xpt
Name	suppis

Dataset2

Row	STUDYID	DOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	XYZ	IS	XYZ1234	ISSEQ	1	ISABTR	Antibody Target	MULTIPLE	CRF
2	XYZ	IS	XYZ1234	ISSEQ	1	ISABTR1	Antibody Target 1	DOG DANDER ANTIGEN	CRF
3	XYZ	IS	XYZ1234	ISSEQ	1	ISABTR2	Antibody Target 2	CAT DANDER ANTIGEN	CRF
4	XYZ	IS	XYZ1234	ISSEQ	1	ISABTR3	Antibody Target 3	HORSE DANDER ANTIGEN	CRF
5	XYZ	IS	XYZ1234	ISSEQ	1	ISABTR4	Antibody Target 4	COW DANDER ANTIGEN	CRF
6	XYZ	IS	XYZ1234	ISSEQ	10	ISABTR	Antibody Target	MULTIPLE	CRF
7	XYZ	IS	XYZ1234	ISSEQ	10	ISABTR1	Antibody Target 1	BOX ELDER POLLEN	CRF
8	XYZ	IS	XYZ1234	ISSEQ	10	ISABTR2	Antibody Target 2	OLIVE TREE POLLEN	CRF
9	XYZ	IS	XYZ1234	ISSEQ	10	ISABTR3	Antibody Target 3	SILVER BIRCH POLLEN	CRF

Dataset wrap

title	lb.xpt
Name	suppis

Dataset2

Row	STUDYID	DOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL
1	XYZ	IS	XYZ1234	ISSEQ	1	ISALGREG	Allergen Mixture Region	CENTRAL CA, AREA 14	CRF
2	XYZ	IS	XYZ1234	ISSEQ	10	ISALGREG	Allergen Mixture Region	SOUTHERN FL, AREA 3	CRF

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