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Dataset wrap
NamePI
Dataset2

Row

STUDYID

DOMAIN

USUBJID

SPTOBID

PISEQ

PILNKID

PITERM

PIDECOD

PIMODIFY

PIACNDEV

PIPATT

PISTDTC

1

TB123

PI

2029

VAPE-Z01

1


Broken Heater

Mechanical Problem

Mechanical Problem

DEVICE REPLACED

SINGLE

2009-12-28

2

TB123

PI

1059

VAPE-Z01

1


Won’t charge

Charging Problem

Charging Problem

BATTERY REPLACED

SINGLE

2009-01-05

3

TB123

PI

3067

VAPE-Z01

1

1

Battery Malfunction

Battery Problem

Battery Problem

BATTERY REPLACED

INTERMITTENT

2009-01-05

Below is the dataset, SUPPPI, used to represent the non-standad varibables used for coding the issue or event. The parent domain (RDOMAIN) is PI, and IDVAR is PISEQ. 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. 

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In this study, subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown below  below for brevity.  

Dataset wrap
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPTOBIDAESEQAELNKIDAETERMAERLDEVEPOCHAESTDTCAEENDTCAESTDYAEENDY
1TB123AE3067VAPE-Z0111SKIN REDNESSRELATEDPRODUCT EXPOSURE2009-01-052009-01-071417

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

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