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This is an example of an ADLB dataset and is based on input from the SDTM LB dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL).

Example

This is an example SDTM datasets used to create the ADLB dataset. Only variables needed for illustration are shown in the examples.

lb.xpt

lb.xpt

ROW

STUDYID

DOMAIN

USUBJID

LBSEQ

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBORNRLOLBORNRHI

LBSTRESC

LBSTRESN

LBSTRESU

LBSTNRCLBSTNRLOLBSTNRHILBNRINDLBLOINCLBSPECLBLOBXFLLBCLSIG

VISITNUM

LBDTC

1A123LBA20011WBCLeukocytesHEMATOLOGY11.010^9/L4.511.011.011.010^9/L
4.511.0
26464-8BLOODY
12021-1-02
2A123LBA20012RBCRBCHEMATOLOGY5.410^12/L4.76.15.45.410^12/L
4.76.1
33051-4BLOODY
12021-1-02
3A123LBA20013PLATPlateletsHEMATOLOGY15810^9/L15040015815810^9/L
150400
49497-1BLOODY
12021-1-02
4A123LBA20014HGBHemoglobinHEMATOLOGY14.5g/dL141814.514.5g/dL
1418
718-7BLOODY
12021-1-02
5A123LBA20015CHOLCholesterolCLINICAL CHEMISTRY229mg/dL200
229229mg/dL
200

2093-3BLOODY
12021-1-02
6A123LBA20016ALBAlbuminCLINICAL CHEMISTRY40.0g/L34544.04.0g/dL
3.45.4
2862-1BLOODY
12021-1-02
7A123LBA20017CREATCreatinineCLINICAL CHEMISTRY0.8mg/dL0.71.30.80.8mg/dl
0.71.3
2160-0BLOODY
12021-1-02
8A123LBA20018SPGRAVSpecific GravityURINALYSIS1.002
1.0051.030



1.0051.030
2965-2URINEY
12021-1-02
9A123LBA20019CANNABCannabinoidsDRUG TOXICITYPOSITIVE


POSITIVE

NEGATIVE

ABNORMAL18282-4URINEYY12021-1-02
$warningHtml

This is an example of the ADLB dataset and associated metadata. This is just an example and does not mean to indicate that ADLB must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study. 

$titleHtml

adlb.xpt

Row

STUDYID

USUBJID

TRTP

TRT01P

TRTA

TRT01A

ADT

ADY

AVISIT

AVISITN

PARAM

PARAMCD

PARAMN

PARCAT1

AVAL

AVALC

BASECHGPCHGABLFLANL01FLLBSTNRCANRLOANRHIANRINDLBLOINCLBSPECRANDFLSAFFLTRTSDTTRTEDTLBCLSIG

LBSEQ

VISITNUM

LBDTC

1A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021

-6

SCREENING1Leukocytes (10^9/L)WBC6HEMATOLOGY11.0
11.0

YY
4.511.0
26464-8BLOODYY2021-01-082021-01-28
112021-01-02
2A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1RBC (10^12/L)RBC8HEMATOLOGY5.4
5.4

YY
4.76.1
33051-4BLOODYY2021-01-082021-01-28
212021-01-02
3A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1Platelets (10^9/L)PLAT7HEMATOLOGY158
158

YY
150400
49497-1BLOODYY2021-01-082021-01-28
312021-01-02
4A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1Hemoglobin (g/dL)HGB5HEMATOLOGY14.5
14.5

YY
1418
718-7BLOODYY2021-01-082021-01-28
412021-01-02
5A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1Cholesterol (mg/dL)CHOL2CLINICAL CHEMISTRY229
229

YY
200

2093-3BLOODYY2021-01-082021-01-28
512021-01-02
6A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1Albumin (g/L)ALB1CLINICAL CHEMISTRY4.0
4.0

YY
3.45.4
2862-1BLOODYY2021-01-082021-01-28
612021-01-02
7A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1Creatinine (mg/dL)CREAT3CLINICAL CHEMISTRY0.8
0.8

YY
0.71.3
2160-0BLOODYY2021-01-082021-01-28
712021-01-02
8A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021

-6

SCREENING1Urine Specific GravityUSPGRAV9URINALYSIS




YY
1.0051.030
2965-2URINEYY2021-01-082021-01-28
812021-01-02
9A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1CannabinoidsCANNAB4DRUG TOXICITY
POSITIVE




NEGATIVE

ABNORMAL18282-4URINEYY2021-01-082021-01-28Y912021-01-02
$warningHtml

ADLB Dataset Metadata

ADLB Variable Metadata

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