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NEED TO CONFIRM DOMAIN NAMES AND STRUCTURE and EXPECTED variables . This uses Ptoduct Identifier domain and the Product EVENTS we can not use PE letters

This is an example of a study where the sponsor collected events associated with the operation of the electronic cigarette device. Events not specifically associated with the device should not be represented in this domain.  

...

The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TOPI) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one product was of interest in the study.   Note this identifier also describes any device use by the subject to deliver the tobacco.   

Dataset wrap
NamePI
Dataset2
RowSTUDYIDDOMAINSPTOBIDPISEQPITESTCDPITESTPICATPIORRESPIORRESUPISTRESCPISTRESNPISTRESU
1TB005PIVAPE-Z01

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERENDS (VAPES)
ENDS (VAPES)

2TB005PIVAPE-Z012TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERClosed CLOSED E-CigaretteCIGARETTEClosed
CLOSED E-CigaretteCIGARETTE

3TB005PIVAPE-Z013MANUFManufacturerPRODUCT IDENTIFIERXX Vapes XXX VAPES USA
XXX Vapes VAPES USA

Sponsor may use standardized or dictionary-derived text for the description of a device event/problem. CDISC does not provide information on what standardized or dictionary-derived text should be used. 

...

Dataset wrap
NamePI
Domain
Dataset2

Row

STUDYID

DOMAIN

USUBJID

SPTOBID

PISEQ

PXXSEQ

PILNKID

PXXLNKID

PITERM

PXXTERM

PIDECOD

PXXDECOD

PIMODIFY

PXXMODIFY

PIACNDEV

PXXACNDEV

PISTDTC

PXXISTDTC

PIIMDRCD


PXXIIMDRCD

PIIMDRL2

PXXIMDRL2

PIIMDRL1

PXXIMDRL1

1

TB005

PI

PXXX

2029

VAPE-Z01

1


Broken Heater

Mechanical Problem

Mechanical Problem

Device Replaced

2009-12-28


A05

Mechanical Problem

Mechanical Problem

2

TB005

PI

PXXXI

1059

VAPE-Z01

1


Won’t charge

Charging Problem

Charging Problem

Battery Replaced

2009-01-05


A0706

Charging Problem

Electrical /Electronic Property Problem

3

TB005

PI

PXXXX

3067

VAPE-Z01

1

1

Battery Malfunction

Battery Problem

Battery Problem

Battery Replaced

2009-01-05


A0705

Battery Problem

Electrical /Electronic Property Problem

Nsvmeta

PI
VariableLabelTypeRoleOrigin
PIIMDRCDIMDR Code CharNon-standard Variable Qualifier of DEDECOD  Assigned
PIIMDRL2IMDR Level 2CharNon-standard Variable Qualifier of DEDECOD Assigned
PIIMDRL1IMDR Level 1CharNon-standard Variable Qualifier of DEDECOD Assigned

This example illustrates how the coding information for a product issue might be represented. The parent domain (RDOMAIN) is PIPXX, and IDVAR is PISEQPXXSEQ. QNAM holds the name of the supplemental qualifier variable being defined. This only shows the data for subject 2029. The data recorded in QVAL applies to the subject’s records, where IDVAR (PISEQ) equals the value specified in IDVARVAL.

Dataset wrap
NamesuppPI
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
11996001PIPXX2029PISEQ1PIIMDRCDPXXIMDRCDIMDR CodeAO5ASSIGNED
21996001PIPXX2029PISEQ1PIIMDRL2PXXIMDRL2IMDR Level 2Mechanical ProblemASSIGNED
31996001PIPXX2029PISEQ1PIIMDRL1PXXIMDRL1IMDR Level 1Mechanical ProblemASSIGNED

Subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown for brevity.  

Dataset wrap
Dataset2
RowSTUDYIDDOMAINUSUBJIDAESEQAELNKIDAETERMEPOCHAESTDTCAEENDTCAESTDYAEENDY
1TB005AE306711SKIN REDNESSPRODUCT EXPOSURE  2009-01-052009-01-071418

The RELREC dataset was used to record the relationship between the Product Events in PI and reported AE represented in AE dataset. 

Expand
titlerelrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TB005PIPXX
PILNKID
ONEAEPI1
2TB005AE
AELNKID
ONEAEPI

...