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

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

Suggested changes:

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

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.

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	Olive Tree pollenBOX ELDER POLLEN	CRF
8	XYZ	IS	XYZ1234	ISSEQ	10	ISABTR2	Antibody Target 2	Mango Tree pollenOLIVE TREE POLLEN	CRF
9	XYZ	IS	XYZ1234	ISSEQ	10	ISABTR3	Antibody Target 3	Silver Birch Tree PollenSILVER 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

CENTRAL FL, AREA 50

CRF

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.

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.

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

12453333

ARIGEAB

Allergen-induced IgE Antibody

ANIMAL MIX ANTIGENS, MULTIPLE

POSITIVE

SERUM

RIA

1

SCREENING

2018-06-20

2

XYZ

IS

XYZ1234

2

12456666

ARIGEAB

Allergen-induced IgE Antibody

DOG DANDER ANTIGEN

0.12

U/mL

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

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

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

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

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

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

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

SERUM

RIA

1

SCREENING

2018-06-20

Dataset wrap

Name	suppis

Dataset2

Row

STUDYID

DOMAIN

USUBJID

IDVAR

IDVARVAL

QNAM

QLABEL

QVAL

QORIG

QEVAL

1

XYZ

IS

XYZ1234

ISSEQ

1

ISBDAG1

Binding Agent 1

DOG

CRF

2

XYZ

IS

XYZ1234

ISSEQ

1

ISBDAG2

Binding Agent 2

CAT

CRF

3

XYZ

IS

XYZ1234

ISSEQ

1

ISBDAG3

Binding Agent 3

HORSE

CRF

4

XYZ

IS

XYZ1234

ISSEQ

1

ISBDAG4

Binding Agent 4

COW

CRF

Dataset wrap

title	lb.xpt
Name	suppis

CENTRAL CA, AREA 14

Dataset2

Row	STUDYID	DOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL
1	XYZ	IS	XYZ1234	ISSEQ	1	ISALGREG	Allergen Mixture Region

SOUTHERN FL, AREA 3

CRF

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