This is an example of the SDTM LB dataset used to represent routine safety laboratory tests.
The LB dataset used the UNIT codelist for LBORRESU and LBORRESU. The LBLOINC variable contains a code from the LOINC database that identifies a specific laboratory test. The LOINC to LB Mapping Codetable (available at https://www.cdisc.org/standards/terminology/controlled-terminology) may be used to identify appropriate CDISC CT values for a test with a particular LOINC code.
LBNRIND was added to indicate where a result falls with respect to reference range defined by LBORNRLO and LBORNRHI. LBSTNRC was used to populated a normal range values that are character values for an ordinal scale (e.g., “NEGATIVE"). LBORNRLO, LBORNRHI, LBSTNRLO, and LBSTNRHI are null for these types of tests.
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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-283 |
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| Rowcaps |
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| Rows 1-4: | Show records for common tests to evaluate hematology. The applicant used LBCAT (HEMATOLOGY) to group these tests. | | Rows 5, 7, 8: | Show records for common tests. LBCAT indicates the category assigned for these laboratory tests. | | Row 6: | Shows a value collected in 1 unit but converted to selected standard unit. | | Row 9: | Shows use of LBSTNRC for cannabinoids that is not reported as a continuous numeric result. The result was evaluated by the investigator and determined to be clinically significant |
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| Dataset2 |
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ROW | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRC | LBSTNRLO | LBSTNRHI | LBNRIND | LBLOINC | LBSPEC | LBLOBXFL | LBCLSIG | VISITNUM | LBDTC |
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| 1 | TBLB001 | LB | 001-001 | 1 | WBC | Leukocytes | HEMATOLOGY | 11.0 | 10^9/L | 4.5 | 11.0 | 11.0 | 11.0 | 10^9/L |
| 4.5 | 11.0 |
| 26464-8 | BLOOD | Y |
| 1 | 2020-12-01 | | 2 | TBLB001 | LB | 001-001 | 2 | RBC | RBC | HEMATOLOGY | 5.4 | 10^12/L | 4.7 | 6.1 | 5.4 | 5.4 | 10^12/L |
| 4.7 | 6.1 |
| 33051-4 | BLOOD | Y |
| 1 | 2020-12-01 | | 3 | TBLB001 | LB | 001-001 | 3 | PLAT | Platelets | HEMATOLOGY | 158 | 10^9/L | 150 | 400 | 158 | 158 | 10^9/L |
| 150 | 400 |
| 49497-1 | BLOOD | Y |
| 1 | 2020-12-01 | | 4 | TBLB001 | LB | 001-001 | 4 | HGB | Hemoglobin | HEMATOLOGY | 14.5 | g/dL | 14 | 18 | 14.5 | 14.5 | g/dL |
| 14 | 18 |
| 718-7 | BLOOD | Y |
| 1 | 2020-12-01 | | 5 | TBLB001 | LB | 001-001 | 5 | CHOL | Cholesterol | CLINICAL CHEMISTRY | 229 | mg/dL | 200 |
| 229 | 229 | mg/dL |
| 200 |
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| 2093-3 | BLOOD | Y |
| 1 | 2020-12-01 | | 6 | TBLB001 | LB | 001-001 | 6 | ALB | Albumin | CLINICAL CHEMISTRY | 40.0 | g/L | 34 | 54 | 4.0 | 4.0 | g/dL |
| 3.4 | 5.4 |
| 2862-1 | BLOOD | Y |
| 1 | 2020-12-01 | | 7 | TBLB001 | LB | 001-001 | 7 | CREAT | Creatinine | CLINICAL CHEMISTRY | 0.8 | mg/dL | 0.7 | 1.3 | 0.8 | 0.8 | mg/dl |
| 0.7 | 1.3 |
| 2160-0 | BLOOD | Y |
| 1 | 2020-12-01 | | 8 | TBLB001 | LB | 001-001 | 8 | SPGRAV | Specific Gravity | URINALYSIS | 1.002 |
| 1.005 | 1.030 |
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| 1.005 | 1.030 |
| 2965-2 | URINE | Y |
| 1 | 2020-12-01 | | 9 | TBLB001 | LB | 001-001 | 9 | CANNAB | Cannabinoids | DRUG TOXICITY | POSITIVE |
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| POSITIVE |
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| POSITIVE |
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| ABNORMAL | 18282-4 | URINE | Y | Y | 1 | 2020-12-01 |
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