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This is an example of an ADaM dataset designed to describe the main variables needed to evaulate vital signs. The dataset decribed below is called ADVS and is based on the SDTM VS dataset shown here SDTM Example.Vital Signs.

The ADaM ADSL  associated with this study are not shown. An example on the creation of an ADLS for another study is provided here ADaM Example.ADSL Analysis Data Subject Level New   

Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study Identifiertext
ReqVS.STUDYID
USUBJIDUnique Subject Identifiertext
ReqVS.USUBJID
TRTPPlanned TreatmentChar
CondADSL.TRT01P
TRT01PPlanned Treatment for Period 01Char
CondADSL.TRT01P
TRTAActual TreatmentChar
CondADSL.TRT01A
TRT01AActual Treatment for Period 01Char
CondADSL.TRT01A
ADTAnalysis DateNum
PermVS.VSDTC captured as a date in numeric format.
ADTMAnalysis Datetime

integer



PermVS.VSDTC captured as a datetime in numeric format.
ADYAnalysis Relative DayNum
PermVS.VSDY
AVISITAnalysis VisitChar
CondVS.VISIT
AVISITNAnalysis Visit (N)Num
PermVS.VISITNUM
ATPTAnalysis TimepointChar
CondVS.VSTPT
APHASEPhaseChar
Permif ADT lt ADSL,TRTSDT then set to SCREENING, else if TRTSDT le ADT le TRTEDT then set to TREATMENT, else if ADT gt TRTEDT then set to FOLLOW-UP
APERIODPeriodNum
Condset to 1 if TRTSDT le ADT le TRTEDT and there is only one treatment period
PARAMParameterChar
Reqset to VS.VSTEST concatenated with VS.VSTRESU
PARAMCDParameter Codetext
Reqset to VS.VSTESTCD
PARAMNParameter (N)Num
PermNumeric representation of PARAM. sort by VSTESTCD and increment by 1 for each unique value of VSTESTCD
AVALAnalysis ValueNum
CondVS.VSSTRESN for records taken from VS, Average of values taken on same datedataset.
AVALCAnalysis Value (C)Char
CondVS.VSSTRESC where VS.vSTRESN is null
BASEBaseline ValueNum
CondAVAL where ABLFL=Y
CHGChange from BaselineNum
PermAVAL-BASE
PCHGPercent Change from BaselineNum
Perm((AVAL-BASE)/BASE)*100
DTYPEDerivation TypeCharAVERAGECondset to AVERAGE for rows added to capture average value for parameters with multiple assessments done at a VISIT
ABLFLBaseline Record FlagCharYCondset to Y on the record that captures the baseline value
ANL01FLAnalysis Flag 01CharYCondset to Y on record chosen to represent AVISIT for analysis
COUNTRYCountryChar
PermADSL.COUNTRY
AGEAgeNum
PermADSL.AGE
SEXSexChar
PermADSL.SEX
RACERaceChar
PermADSL.RACE
ETHNICEthnicityChar
PermADSL.ETHNIC
SAFFLSafety Population FlagCharY;NCondADSL.SAFFL
RANDFLRandomized Population FlagCharY;NCondADSL.RANDFL
TRTSDTDate of First Exposure to TreatmentNum
PermADSL.TRTSDT
TRTSDTMDatetime of First Exposure to TreatmentNum
PermADSL.TRTSDTM
TRTEDTDate of Last Exposure to TreatmentNum
PermADSL.TRTEDT
TRTEDTMDatetime of Last Exposure to Treatmentinteger
PermADSL.TRTEDTM
VSSEQSequence NumberNum
PermVS.VSSEQ
VISITVisit NameChar
PermVS.VISIT
VISITNUMVisit NumberNum
PermVS.VISITNUM
VSTPTPlanned Time
Point Name
Char
PermVS.VSTPT
VSTPTNUMPlanned Time
Point Number
Char
PermVS.VSTPTNUM
STUDYIDUSUBJIDTRTPTRT01PTRTATRT01AADTADTMADYAVISITAVISTNATPTATPTNAPHASEAPERIODPARAMPARAMCDPARAMNAVALBASECHGPCHGDTYPEABLFLVSSEQVSTESTCDVSTESTVSPOSVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSSTATVSREASNDVSLOCVSLATVSLOBXFLVISITNUMVISITVSDTCVSDYVSTPTVSTPTNUM
ABCABC-001-001Product AProduct AProduct AProduct A19JUN199919JUN1999:08:45

1

Baseline1Baseline 11SCREENING
Systolic Blood Pressure (mmHg)SYSBP4154




1SYSBPSystolic Blood PressureSITTING154mmHg154154mmHg

ARMLEFT
1Baseline1999-06-19T08:451BASELINE 11
ABCABC-001-001Product AProduct AProduct AProduct A19JUN199919JUN1999:09:001Baseline1Baseline 22SCREENING
Systolic Blood Pressure (mmHg)SYSBP4152




2SYSBPSystolic Blood PressureSITTING152mmHg152152mmHg

ARMLEFTY1Baseline1999-06-19T09:001BASELINE 22
ABCABC-001-001Product AProduct AProduct AProduct A19JUN1999
1Baseline1

SCREENING
Systolic Blood Pressure (mmHg)SYSBP41531530
AVERAGEY














Baseline



ABCABC-001-001Product AProduct AProduct AProduct A19JUN199919JUN1999:08:451Baseline1Baseline 11SCREENING
Diastolic Blood Pressure (mmHg)DIABP144




3DIABPDiastolic Blood PressureSITTING44mmHg4444mmHg

ARMLEFT
1Baseline1999-06-19T08:451BASELINE 11
ABCABC-001-001Product AProduct AProduct AProduct A19JUN199919JUN1999:09:001Baseline1Baseline 22SCREENING
Diastolic Blood Pressure (mmHg)DIABP148




4DIABPDiastolic Blood PressureSITTING48mmHg4848mmHg

ARMLEFTY1Baseline1999-06-19T09:001BASELINE 22
ABCABC-001-001Product AProduct AProduct AProduct A19JUN1999
1Baseline1

SCREENING
Diastolic Blood Pressure (mmHg)DIABP146460
AVERAGEY














Baseline



ABCABC-001-001Product AProduct AProduct AProduct A19JUN1999
1Baseline1

SCREENING
Pulse Rate (beats/min)PULSE372720

Y5PULSEPulse RateSITTING72beats/min7272beats/min

ARMLEFTY1Baseline1999-06-191

ABCABC-001-001Product AProduct AProduct AProduct A19JUN199919JUN1999:08:451Baseline1Baseline 11SCREENING
Temperature (C)TEMP534.7




6TEMPTemperature
34.7C34.734.7C

SUBLINGUAL REGION

1Baseline1999-06-19T08:451BASELINE 11
ABCABC-001-001Product AProduct AProduct AProduct A19JUN199919JUN1999:09:001Baseline1Baseline 22SCREENING
Temperature (C)TEMP536.2




7TEMPTemperature
36.2C36.236.2C

SUBLINGUAL REGION
Y1Baseline1999-06-19T09:001BASELINE 22
ABCABC-001-001Product AProduct AProduct AProduct A19JUN1999
1Baseline1

SCREENING
Temperature (C)TEMP535.4535.450
AVERAGEY














Baseline



ABCABC-001-001Product AProduct AProduct AProduct A19JUN1999
1Baseline1

SCREENING
Weight (kg)WEIGHT690.590.50

Y8WEIGHTWeightSTANDING90.5kg90.590.5kg



Y1Baseline1999-06-191

ABCABC-001-001Product AProduct AProduct AProduct A19JUN1999
1Baseline1

SCREENING
Height (cm)HEIGHT21571570

Y9HEIGHTHeightSTANDING157cm157157cm



Y1Baseline1999-06-191

ABCABC-001-001Product AProduct AProduct AProduct A

21JIL1999


33Visit 22

TREATMENT
Systolic Blood Pressure (mmHg)SYSBP495153-58-37.9085

10SYSBPSystolic Blood PressureSITTING95mmHg9595mmHg

ARMLEFT
2Visit 21999-07-2133

ABCABC-001-001Product AProduct AProduct AProduct A21JIL1999
33Visit 22

TREATMENT
Diastolic Blood Pressure (mmHg)DIABP14446-2-4.3478

11DIABPDiastolic Blood PressureSITTING44mmHg4444mmHg

ARMLEFT
2Visit 21999-07-2133

ABCABC-001-001Product AProduct AProduct AProduct A21JIL1999
33Visit 22

TREATMENT
Temperature (C)TEMP536.235.45.75

2.1157




12TEMPTemperature
97.16F36.236.2C

SUBLINGUAL REGION

2Visit 21999-07-2133

ABCABC-001-001Product AProduct AProduct AProduct A21JIL1999
33Visit 22

TREATMENT
Weight (kg)WEIGHT6
90.5



13WEIGHTWeight





NOT DONESUBJECT REFUSED


2Visit 2



Visit 2

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