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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 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 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. 

TOBA-283 - Getting issue details... STATUS

Rows 1-4:Show records for common tests to evaluate hematology. The applicant used LBCAT (HEMATOLOGY) to group these tests.
Rows 5,7,8Show 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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lb.xpt

lb.xpt

ROW

STUDYID

DOMAIN

USUBJID

LBSEQ

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBORNRLOLBORNRHI

LBSTRESC

LBSTRESN

LBSTRESU

LBSTNRCLBSTNRLOLBSTNRHILBNRINDLBLOINCLBSPECLBLOBXFLLBCLSIG

VISITNUM

LBDTC

1TBLB001LB001-0011WBCLeukocytesHEMATOLOGY11.010^9/L4.511.011.011.010^9/L
4.511.0
26464-8BLOODY
12020-12-01
2TBLB001LB001-0012RBCRBCHEMATOLOGY5.410^12/L4.76.15.45.410^12/L
4.76.1
33051-4BLOODY
12020-12-01
3TBLB001LB001-0013PLATPlateletsHEMATOLOGY15810^9/L15040015815810^9/L
150400
49497-1BLOODY
12020-12-01
4TBLB001LB001-0014HGBHemoglobinHEMATOLOGY14.5g/dL141814.514.5g/dL
1418
718-7BLOODY
12020-12-01
5TBLB001LB001-0015CHOLCholesterolCLINICAL CHEMISTRY229mg/dL200
229229mg/dL
200

2093-3BLOODY
12020-12-01
6TBLB001LB001-0016ALBAlbuminCLINICAL CHEMISTRY40.0g/L34544.04.0g/dL
3.45.4
2862-1BLOODY
12020-12-01
7TBLB001LB001-0017CREATCreatinineCLINICAL CHEMISTRY0.8mg/dL0.71.30.80.8mg/dl
0.71.3
2160-0BLOODY
12020-12-01
8TBLB001LB001-0018SPGRAVSpecific GravityURINALYSIS1.002
1.0051.030



1.0051.030
2965-2URINEY
12020-12-01
9TBLB001LB001-0019CANNABCannabinoidsDRUG TOXICITYPOSITIVE


POSITIVE

POSITIVE

ABNORMAL18282-4URINEYY12020-12-01
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