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).
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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 the ones that would be used in a particular study.
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adlb.xpt
STUDYID
USUBJID
TRTP
TRT01P
TRTA
TRT01A
ADT
ADY
AVISIT
AVISITN
LBSEQ
PARAM
PARAMCD
PARAMN
PARCAT1
AVALC
AVAL
LBSTRESU
LBSTNRC
ANRLO
ANRHI
ANRIND
LBLOINC
LBSPEC
ABLFL
LBCLSIG
VISITNUM
LBDTC
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
1
Leukocytes (10^9/L)
WBC
6
HEMATOLOGY
11.0
10^9/L
4.5
11.0
26464-8
BLOOD
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
2
RBC (10^12/L)
RBC
8
HEMATOLOGY
5.4
10^12/L
4.7
6.1
33051-4
BLOOD
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
3
Platelets (10^9/L)
PLAT
7
HEMATOLOGY
158
10^9/L
150
400
49497-1
BLOOD
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
4
Hemoglobin (g/dL)
HGB
5
HEMATOLOGY
14.5
g/dL
14
18
718-7
BLOOD
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
5
Cholesterol (mg/dL)
CHOL
2
CLINICAL CHEMISTRY
229
mg/dL
200
2093-3
BLOOD
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
6
Albumin (g/L)
ALB
1
CLINICAL CHEMISTRY
4.0
g/dL
3.4
5.4
2862-1
BLOOD
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
7
Creatinine (mg/dL)
CREAT
3
CLINICAL CHEMISTRY
0.8
mg/dl
0.7
1.3
2160-0
BLOOD
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
8
Urine Specific Gravity
USPGRAV
9
URINALYSIS
1.005
1.030
2965-2
URINE
Y
1
2020-12-01
A123
2001
Placebo
Placebo
Placebo
Placebo
02JAN2021
-5
9
Cannabinoids
CANNAB
4
DRUG TOXICITY
POSITIVE
POSITIVE
ABNORMAL
18282-4
URINE
Y
Y
1
2020-12-01
Dataset Debug Message
There are five leading, trailing, or non-breaking spaces in the dataset.
ADLB Dataset Metadata
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADLB
Analysis
,
ADSL.xpt
ADLB.SAS/SAP
ADLB Variable Metadata
Variable Name
Variable Label
Type
Codelist/Controlled Terms
Core
CDISC Notes
STUDYID
Study Identifier
Char
Req
LB.STUDYID
USUBJID
Unique Subject Identifier
Char
Req
LB.USUBJID
TRTP
Planned Treatment
Char
Cond
ADSL.TRT01P
TRT01P
Planned Treatment for Period 01
Char
Cond
ADSL.TRT01P
TRTA
Actual Treatment
Char
Cond
ADSL.TRT01A
TRTx01A
Actual Treatment for Period 01
Char
Cond
ADSL.TRT01A
ADT
Analysis Date
Num
Perm
LB.LBDTC captured in numeric format
ADY
Analysis Relative Day
Num
Perm
LB.LBDY
AVISIT
Analysis Visit
Char
Cond
LB.VISIT
AVISITN
Analysis Visit (N)
Num
Perm
LB.VISITNUM
PARAM
Parameter
Char
Req
LB.LBTEST concatenated with LB.LBSTRESU - if PARCAT1=URINALYSIS then preface with Urine
PARAMCD
Parameter Code
text
Req
LB.LBTESTCD - if PARCAT1=URINALYSIS then preface with U
PARAMN
Parameter (N)
Num
Perm
Numeric representation of PARAM. Sort by PARCAT! and PARAMCD and increment by 1 for each new LBTESTCD
PARCAT1
Parameter Category 1
Char
Perm
LB.LBCAT
AVAL
Analysis Value
Num
Cond
LB.LBSTRESN
AVALC
Analysis Value (C)
Char
Cond
LB.LBSTRESC where LB.LBSTRESN is null
BASE
Baseline Value
Num
Cond
AVAL where ABLFL=Y
CHG
Change from Baseline
Num
Perm
AVAL-BASE - populated on ABLFL=Y records and post-baseline records
PCHG
Percent Change from Baseline
Num
Perm
derived as ((AVAL-BASE)/BASE)*100
ABLFL
Baseline Record Flag
Char
Y
Cond
set to Y for last pre-treatment value within each PARAM