| 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.
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 if need be, discuss with team, but suppIS row 1 should be QNAM = "MULTIPLE" followed by QNAM = XXXXXX1-4.change QVAL to Dog Dander, Cat Dander, Horse Dander, Cow Dander| 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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. 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. |
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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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10Allergen-induced IgE Antibody | ANIMAL MIX ANTIGENS | NEGATIVE | |
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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | IDVARIDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL | 1 | ISSEQ1ISTARAG | Target Antigen? Antibody Target? | MULTIPLE | CRF | 2 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISTARAG1 | Target Antigen 1 | DOG DANDER | CRF | 3 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISTARAG2 | Target Antigen 2 | CAT DANDER | CRF | 4 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISTARAG3 | Target Antigen 3 | HORSE DANDER | CRF | 5 | XYZ | IS | XYZ1234 | ISSEQ | 1 | ISTARAG4 | Target Antigen 4 | COW DANDER | CRF | 6 | XYZ | IS | XYZ1234 | ISSEQ | 10 | ISTARAG | Target Antigen? Antibody Target? | MULTIPLE | CRF | 7 | XYZ | IS | XYZ1234 | ISSEQ | 10 | ISTARAG | Target Antigen 1 | Olive Tree pollen | CRF | 8 | XYZ | IS | XYZ1234 | ISSEQ | 10 | ISTARAG | Target Antigen 2 | Mango Tree pollen | CRF | 9 | XYZ | IS | XYZ1234 | ISSEQ | 10 | ISTARAG | Target Antigen 3 | Silver Birch Tree Pollen | CRF | |
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| Dataset wrap |
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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 |
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| 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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| Rowcaps |
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| 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". |
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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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| Dataset2 |
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DOMAINISSEQ| ISGRPID | ISREFID | ISTESTCD | ISTEST | ISBDAGNT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | VISITNUM | VISIT | ISDTC | 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 | | IDVARVAL | ISABTR |
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| 1 | XYZ | IS | XYZ1234 |
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1 | 1 | 12453333 | ARIGEAB | Allergen-induced IgE Antibody | ANIMAL MIX ANTIGENS, MULTIPLE | 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 | | ISSEQ | 1 | DOG DANDER ANTIGEN; CAT DANDER ANTIGEN; HORSE DANDER ANTIGEN; COW DANDER ANTIGEN |
64 | 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 | BOX ELDER POLLEN; OLIVE TREE POLLEN; SILVER BIRCH POLLEN |
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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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| Dataset wrap |
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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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ISBDAG1 | Binding Agent 1 | DOG | CRF | | CENTRAL CA, AREA 14 | | 2 | XYZ | IS | XYZ1234 | ISSEQ |
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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 |
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| Dataset wrap |
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| title | lb.xpt |
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| Name | suppisnsis |
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| Dataset2definexmltable |
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Row | STUDYID | DOMAIN | USUBJID | IDVARIDVARVALQNAMQLABEL| 1 | XYZ | IS | XYZ1234 | ISSEQ | 1 | QVAL | QORIG | QEVAL | | ISALGREG | Allergen Mixture Region |
CENTRAL CA, AREA 14 | CRF| Char |
| Non-Standard Qualifier |
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