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| Row | STUDYID | USUBJID | TRTP | ADT | ADTM | AENDTM | AVISIT | AVISITN | PARAMCD | PARAM | PARCAT1 | AVAL | ABLFL | SAFFL | TRTSDT | TRTEDT | LBSTRESN | LBSTRESU | LBNAM | LBLOINC | LBSPEC | LBMETHOD | LBLOBXFL | LBLLOQ | VISITNUM | VISIT | LBDTC | LBENDTC | LBSEQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TOB777 | 001 | Product A | 17JAN2021 | Baseline | 0 | NICOTINE | Nicotine (ng/mL) | TOBACCO ALKALOID | 30 | Y | Y | 2021-01-20 | 2021-12-20 | 30 | ng/mL | Tobacco Marker Testing Laboratory | 3853-9 | SERUM | LC/MS/MS | Y | 2 | 1 | BASELINE | 2021-01-17 | 1 | |||
| 2 | TOB777 | 001 | Product A | 20JUL2021 | Day 180 | 180 | COTININE | Cotinine (ng/mL) | TOBACCO ALKALOID | 400 | Y | 2021-01-20 | 2021-12-20 | 400 | ng/mL | Tobacco Marker Testing Laboratory | 10365-5 | SERUM | LC/MS/MS | 2 | 3 | Day 180 | 2021-07-20 | 2 | |||||
| 3 | TOB777 | 002 | Product A | 21JUN2021 | 21JUN2021:08:00 | 22JUN2021:08:00 | Baseline | 0 | CREAT | Creatinine (ng/mL) | 24-HOUR URINE TEST | 0.8 | Y | Y | 2021-01-20 | 2021-12-20 | 0.8 | ng/mL | Tobacco Marker Testing Laboratory | 65634-8 | URINE | LC-MS-MS | Y | 1 | BASELINE | 2021-06-21T08:00 | 2021-06-22T08:00 | 1 | |
| 4 | TOB777 | 002 | Product A | 21JUN2021 | 21JUN2021:08:00 | 22JUN2021:08:00 | Baseline | 0 | VOLUME | Volume (mL) | 24-HOUR URINE TEST | 1875 | Y | Y | 2021-01-20 | 2021-12-20 | 1875 | mL | Tobacco Marker Testing Laboratory | URINE | Y | 1 | BASELINE | 2021-06-21T08:00 | 2021-06-22T08:00 | 2 | |||
| 5 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | NICOTINE | Nicotine (ng/mL) | TOBACCO ALKALOID | 45 | Y | 2021-01-20 | 2021-12-20 | 45 | ng/mL | Tobacco Marker Testing Laboratory | 3854-7 | URINE | LC-MS/MS | 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 3 | ||
| 6 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | NICGLUC | Nicotine-glucuronide (ng/mL) | TOBACCO ALKALOID | 40 | Y | 2021-01-20 | 2021-12-20 | 40 | ng/mL | Tobacco Marker Testing Laboratory | URINE | 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 4 | ||||
| 7 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | NOXT | Nicotine-1 N-oxid (ng/mL) | TOBACCO ALKALOID | 113.5 | Y | 2021-01-20 | 2021-12-20 | 113.5 | ng/mL | Tobacco Marker Testing Laboratory | URINE | HPLC-ESI-MS/MS | 2.50 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 5 | |||
| 8 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | COTININE | Cotinine (ng/mL) | TOBACCO ALKALOID | 300 | Y | 2021-01-20 | 2021-12-20 | 300 | ng/mL | Tobacco Marker Testing Laboratory | 10366-3 | URINE | LC/MS/MS) | 0.05 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 6 | ||
| 9 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | COTGLUC | Cotinine-glucuronide (ng/mL) | TOBACCO ALKALOID | 275 | Y | 2021-01-20 | 2021-12-20 | 275 | ng/mL | Tobacco Marker Testing Laboratory | URINE | 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 7 | ||||
| 10 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | COXT | Cotinine-n-oxide (ng/mL) | TOBACCO ALKALOID | 117.5 | Y | 2021-01-20 | 2021-01-20 | 2021-01-20 | 2021-12-20 | Tobacco Marker Testing Laboratory | URINE | HPLC-ESI-MS/MS | 2.02 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 8 | |||
| 11 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | OHCOT or HCTT | Trans-3-hydroxycotinine (ng/mL) | TOBACCO ALKALOID | 2000 | Y | 2021-01-20 | 2021-12-20 | Tobacco Marker Testing Laboratory | 33916-8 | URINE | 0.1 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 9 | |||||
| 12 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | OHCOTG or 3HC-Gluc | Trans-3-hydroxycotinine glucuronide (ng/mL) | TOBACCO ALKALOID | 3529 | Y | 2021-01-20 | 2021-12-20 | 2021-01-20 | 2021-01-20 | 2021-01-20 | 2021-01-20 | 2021-01-20 | 2021-01-20 | 2021-01-20 | 2021-12-20 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 10 | |
| 13 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | NORNCTN or NNIC | Nornicotine (ng/mL) | TOBACCO ALKALOID | 6 | Y | 2021-01-20 | 2021-12-20 | 6 | ng/mL | Tobacco Marker Testing Laboratory | 33917-6 | URINE | LC/MS/MS | 2.50 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 11 | ||
| 14 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | ANBS | Anabasine (ng/mL) | TOBACCO ALKALOID | 5 | Y | 2021-01-20 | 2021-12-20 | 5 | ng/mL | Tobacco Marker Testing Laboratory | 33915-0 | URINE | LC/MS/MS | 0.51 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 12 | ||
| 15 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | NCOT | Norcotinine (ng/mL) | TOBACCO ALKALOID | 2 | Y | 2021-01-20 | 2021-12-20 | 2 | ng/mL | Tobacco Marker Testing Laboratory | 77740-9 | URINE | 1.11 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 13 | |||
| 16 | TOB777 | 002 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 180 | 180 | ANTB | Anatabine (ng/mL) | TOBACCO ALKALOID | 9.1 | Y | 2021-01-20 | 2021-12-20 | 9.1 | ng/mL | Tobacco Marker Testing Laboratory | URINE | HPLC-ESI-MS/MS | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | 14 | ||||
| 17 | TOB777 | 2001 | Product A | 15DEC2021 | 15DEC2021:08:00 | 16DEC2021:08:00 | Day 60 | 60 | OH_2_FLU or 2-FLU | 2-Hydroxyfluorene 3‐Hydroxyfluorene (3‐FLU) (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 30 | Y | 2021-07-15 | 2022-06-30 | 30 | ng/mL | Tobacco Marker Testing Laboratory | 3853-9 | URINE | LC-MS/MS | 2 | Day 60 | 2021-09-15T10:00 | 2021-09-16T09:20 | 1 | |||
| 18 | TOB777 | 2001 | Product A | 15AUG2021 | 15AUG2021:10:00 | 16AUG2021:10:00 | Day 60 | 60 | OH1NAPHT | 1-Hydroxynaphthalene (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 400 | Y | 2021-07-15 | 2022-06-30 | 400 | ng/mL | Tobacco Marker Testing Laboratory | 10365-5 | URINE | LC-MS/MS | 2 | Day 60 | 2021-09-15T10:00 | 2021-09-16T09:20 | 2 | |||
| 19 | TOB777 | 2001 | Product A | 15AUG2021 | 15AUG2021:10:00 | 16AUG2021:10:00 | Day 60 | 60 | OH1PHE | 1-Hydroxyphenanthrene (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 45 | Y | 2021-07-15 | 2022-06-30 | 45 | ng/mL | Tobacco Marker Testing Laboratory | 3854-7 | URINE | LC-MS/MS | 2 | Day 60 | 2021-09-15T10:00 | 2021-09-16T09:20 | 3 | |||
| 20 | TOB777 | 2001 | Product A | 15AUG2021 | 15AUG2021:10:00 | 16AUG2021:10:00 | Day 60 | 60 | OH3BAP | 3-Hydroxybenzo[a]pyrene (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 300 | Y | 2021-07-15 | 2022-06-30 | 300 | ng/mL | Tobacco Marker Testing Laboratory | 10366-3 | URINE | LC-MS/MS | 2 | Day 60 | 2021-09-15T10:00 | 2021-09-16T09:20 | 4 | |||
| 21 | TOB777 | 2001 | Product A | 15AUG2021 | Day 60 | 60 | CO | Carbon Monoxide (%) | VARIOUS GASES | 10 | Y | 10 | % | Tobacco Marker Testing Laboratory | EXPIRED AIR | Multiple Wavelength Spectrophotometer | 2 | Day 60 | 2021-09-15 | 5 |
ADXX 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 Product | Char | Cond | ADSL.TRT01P | |
| ADT | Analysis Date | Num | Perm | LB.LBDTC captured as a date in numeric format. | |
| ADTM | |||||
| AENDTM | Num | Perm | LB.LBDTC captured as a datetime in numeric format. | ||
| 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 | |
| PARAMCD | Parameter Code | text | Req | LB.LBTESTCD | |
| PARCAT1 | Parameter Category 1 | Char | Perm | LB.LBCAT | |
| AVAL | Analysis Value | Num | Cond | LB.LBSTRESN | |
| BASE | Baseline Value | Num | Cond | AVAL where ABLFL=Y | |
| CHG | Change from Baseline | Num | Perm | AVAL-BASE | |
| ABLFL | Baseline Record Flag | Char | Y | Cond | set to Y for last pre-Product assessment fir each parameter |
| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
| TRTSDT | Date of First Exposure to product | Num | Perm | ADSL.TRTSDT | |
| TRTEDT | Date of Last Exposure to Product | Num | Perm | ADSL.TRTEDT | |
| LBSEQ | Sequence Number | Num | Perm | LB.LBSEQ | |
| VISIT | Visit Name | Char | Perm | LB.VISIT | |
| VISITNUM | Visit Number | Num | Perm | LB.VISITNUM |
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