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The LB dataset used the UNIT codelist for LBORRESU and LBORRESU. The LBLOINC variable contains a code from the Logical Observation Identifiers Names and Codes ( LOINC ) database that identifies a specific laboratory test. were included by the applicant. The LOINC to LB Mapping Codetable , (available at https://www.cdisc.org/standards/terminology/controlled-terminology, may ) 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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| 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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| Rows 1-4: | Show records for common tests to evaluate hematology. The applicant used LBCAT (HEMATOLOGY) to group these tests. | | Rows 2-3: | Show 2 records for alkaline phosphatase done at the same visit, a day apart. LBPTFL is set to "Y" for both rows because each result is based on a sample from a single point in time. | Rows 5, 7, 8: | Show records for common test under the grouping CLINICAL CHEMSITRY.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 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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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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