There are a couple of JIRA issues that point out the 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
Below is the updated version of the IS Example 11.
Row 1:
Shows the detection of immunoglobulin E (IgE) antibody against multiple animal allergens.
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.