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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
Suggested changes:
- change IDVAR to ISSEQ in both suppIS datasets.
- change QNAM and QLBEL to ABTR and Antibody Target
- change QVAL to Dog Dander Antigen, Cat Dander Antigen, Horse Dander Antigen, Cow Dander Antigen.
Row 1: | Shows the detection of immunoglobulin E (IgE) antibody against multiple animal allergens. |
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Rows 2-3: | Show the amount of IgE antibody against dog dander and its RAST classification score. |
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Rows 4-5: | Show the amount of IgE antibody against cat dander and its RAST classification score. |
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Rows 6-7: | Show the amount of IgE antibody against horse dander and its RAST classification score. |
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Rows 8-9: | Show the amount of IgE antibody against cow dander and its RAST classification score. |
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Row 10: | Shows immunoglobulin E (IgE) antibody against multiple tree pollen allergens is not detected. |
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is.xpt
is.xpt
Row | STUDYID | DOMAIN | USUBJID | ISSEQ | ISGRPID | ISREFID | ISTESTCD | ISTEST | ISBDAGNT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | VISITNUM | VISIT | ISDTC |
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1 | XYZ | IS | XYZ1234 | 1 | 1 | 12453333 | ARIGEAB | Allergen-induced IgE Antibody | ANIMAL MIX ANTIGENS |
| POSITIVE |
| POSITIVE |
|
| SERUM | RIA | 1 | SCREENING | 2018-06-20 |
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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 |
---|
$warningHtml
is.xpt
suppis.xpt
Row | STUDYID | DOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
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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 |
|
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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 |
|
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9 | XYZ | IS | XYZ1234 | ISSEQ | 10 | ISABTR3 | Antibody Target 3 | SILVER BIRCH POLLEN | CRF |
|
---|
$warningHtml
is.xpt
suppis.xpt
Row | STUDYID | DOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
---|
1 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISALGREG | Allergen Mixture Region | CENTRAL CA, AREA 14 | CRF |
|
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2 | XYZ | IS | XYZ1234 | ISSEQ | 10 | ISALGREG | Allergen Mixture Region | SOUTHERN FL, AREA 3 | CRF |
|
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$warningHtml