| Request | Related JIRA Issues | Status | Fixed/Updated/Removed from SDTMIG v4.0? |
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| Updated IS example 11 in IG3.4 | | | | Status |
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| colour | Green |
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| title | update complete |
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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.
| Info |
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There are a couple of JIRA issues that point out 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 |
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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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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.
| Dataset wrap |
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| title | lb.xpt |
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| Name | suppisnsis |
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| Dataset2 |
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DOMAIN| RDOMAIN | USUBJID | IDVAR | IDVARVAL |
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QNAM | QLABEL | QVAL | QORIG | QEVAL | | ISABTR |
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| 1 | XYZ | IS | XYZ1234 | ISSEQ | 1 |
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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 | | DOG DANDER ANTIGEN; CAT DANDER ANTIGEN; HORSE DANDER ANTIGEN; COW DANDER ANTIGEN |
CRF | XYZ | IS | XYZ1234 | ISSEQ | 10 | ISABTR | Antibody Target | MULTIPLE | CRF7 | ISABTR1 | Antibody Target 1 | | BOX ELDER POLLEN; OLIVE TREE 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 |
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| Dataset wrap |
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| Definexmltable |
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| | Variable | Label | Type | Codelist | Role |
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| ISABTRG | Antibody Target | Char |
| Non-Standard Qualifier |
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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.
| Dataset wrap |
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| title | lb.xpt |
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| Name | suppisnsis |
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| Dataset2 |
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DOMAIN| RDOMAIN | USUBJID | IDVAR | IDVARVAL |
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QNAM | QLABEL | QVAL | QORIG | QEVAL| ISALGREG |
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| 1 | XYZ | IS | XYZ1234 | ISSEQ | 1 |
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ISALGREG | Allergen Mixture Region | CRF | | 2 | XYZ | IS | XYZ1234 | ISSEQ | 10 | SOUTHERN FL, AREA 3 |
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| Dataset wrap |
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| Definexmltable |
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| | Variable | Label | Type | Codelist | Role |
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| ISALGREG | Allergen Mixture Region |
SOUTHERN FL, AREA 3 | CRF| Char |
| Non-Standard Qualifier |
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