There are a couple of JIRA issues that point out errors in the suppIS datasets for IS Example 11 in the SDTMIG 3.4 needs to be updated to cix SuppIS dataset. Related JIRA issues: SDS-2553; SDS-2563Discussion with Richard Marshall: https://wiki.cdisc.org/x/-otLCQ
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
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Rowcaps |
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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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Dataset2 |
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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 |
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| 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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10 | XYZ | IS | XYZ1234 | 10 |
| 12458888 | ARIGEAB | Allergen-induced IgE Antibody | TREE MIX POLLENS |
| NEGATIVE |
| NEGATIVE |
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| SERUM | RIA | 1 | SCREENING | 2018-06-20 |
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Dataset2 |
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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 |
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2 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISABTR1 | Antibody Target 1 | DOG DANDER ANTIGEN | CRF |
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3 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISABTR2 | Antibody Target 2 | CAT DANDER ANTIGEN | CRF |
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4 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISABTR3 | Antibody Target 3 | HORSE DANDER ANTIGEN | CRF |
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5 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISABTR4 | Antibody Target 4 | COW DANDER ANTIGEN | CRF |
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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 |
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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 |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
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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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