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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | PISEQ | PILNKID | PITERM | PIDECOD | PIMODIFY | PIACT | PISTDTC |
| PIIMDRCD | PIIMDRL2 | PIIMDRL1 |
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1 | TB005 | PI | 2029 | VAPE-Z01 | 1 |
| Broken Heater | Mechanical Problem | Mechanical Problem | Device Replaced | 2009-12-28 |
| A05 | Mechanical Problem | Mechanical Problem |
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2 | TB005 | PI | 1059 | VAPE-Z01 | 1 |
| Won’t charge | | Charging Problem | Battery Replaced | 2009-01-05 |
| A0706 | Charging Problem | Electrical /Electronic Property Problem |
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3 | TB005 | PI | 3067 | VAPE-Z01 | 1 | 1 | Battery Malfunction | Battery Problem | Battery Problem | Battery Replaced | 2009-01-05 |
| A0705 | Battery Problem | Electrical /Electronic Property Problem |
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| Nsvmeta |
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| | Variable | Label | Type | Role | Origin |
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| PIIMDRCD | IMDR Code | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | PIIMDRL2 | IMDR Level 2 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | PIIMDRL1 | IMDR Level 1 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned |
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Subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown for brevity .
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | AESEQ | AELNKID | AETERM | EPOCH | AESTDTC | AEENDTC | AESTDY | AEENDY | AEENRF |
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| 1 | TB005 | AE | 3067 | 1 | 1 | SKIN REDNESS | SCREENING | 2009-01-05 | 2009-01-07 | -1 | -1 |
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The RELREC dataset was used to record the relationship between the Product Events in PI and reported AE represented in AE dataset.
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relrec.xpt | 1 | TB005 | PI |
| PILNKID |
| ONE | AEPI1 |
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| 2 | TB005 | AE |
| AELNKID |
| ONE | AEPI |
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