| 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 Treatment | Char | Cond | ADSL.TRT01P | |
| TRT01P | Planned Treatment for Period xx | Char | Cond | ADSL.TRT01P | |
| ADT | Analysis Date | Num | Perm | LB.LBDTC captured as a date in numeric format. | |
| ADTM | Analysis Datetime | Num | Perm | LB.LBDTC captured as a datetime in numeric format. | |
| ADY | Analysis Relative Day | Num | Perm | LB.LBDY | |
| 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 | |
| PARAMN | Parameter (N) | Num | Perm | ||
| 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-treatment assessment fir each parameter |
| COUNTRY | Country | Char | Perm | ADSL.COUNTRY | |
| AGE | Age | Num | Perm | ADSL.AGE | |
| SEX | Sex | Char | Perm | ADSL.SEX | |
| RACE | Race | Char | Perm | ADSL.RACE | |
| ETHNIC | Ethnicity | Char | Perm | ADSL.ETHNIC | |
| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
| RANDFL | Randomized Population Flag | Char | Y;N | Cond | ADSL.RANDFL |
| TRTSDT | Date of First Exposure to Treatment | Num | Perm | ADSL.TRTSDT | |
| TRTEDT | Date of Last Exposure to Treatment | 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 |
| STUDYID | USUBJID | LBSEQ | PARAMCD | PARAM | PARCAT1 | AVAL | BASE | CHG | ABLFL | LBSTRESN | LBSTRESU | LBNAM | LBLOINC | LBSPEC | LBMETHOD | LBLOBXFL | LBLLOQ | VISITNUM | VISIT | LBDTC | LBENDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TOB777 | 001 | 1 | NICOTINE | Nicotine (ng/mL) | TOBACCO ALKALOID | 30 | 30 | ng/mL | Tobacco Marker Testing Laboratory | 3853-9 | SERUM | LC/MS/MS | Y | 2 | 1 | BASELINE | 2021-01-17 | ||||
| TOB777 | 001 | 2 | COTININE | Cotinine (ng/mL) | TOBACCO ALKALOID | 400 | 400 | ng/mL | Tobacco Marker Testing Laboratory | 10365-5 | SERUM | LC/MS/MS | 2 | 3 | Day 180 | 2021-07-20 | |||||
| TOB777 | 002 | 1 | CREAT | Creatinine (ng/mL) | 24-HOUR URINE TEST | 0.8 | 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 | ||||
| TOB777 | 002 | 2 | VOLUME | Volume (mL) | 24-HOUR URINE TEST | 1875 | 1875 | mL | Tobacco Marker Testing Laboratory | URINE | Y | 1 | BASELINE | 2021-06-21T08:00 | 2021-06-22T08:00 | ||||||
| TOB777 | 002 | 3 | NICOTINE | Nicotine (ng/mL) | TOBACCO ALKALOID | 45 | 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 | ||||
| TOB777 | 002 | 4 | NICGLUC | Nicotine-glucuronide (ng/mL) | TOBACCO ALKALOID | 40 | 40 | ng/mL | Tobacco Marker Testing Laboratory | URINE | 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | ||||||
| TOB777 | 002 | 5 | NOXT | Nicotine-1 N-oxid (ng/mL) | TOBACCO ALKALOID | 113.5 | 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 | |||||
| TOB777 | 002 | 6 | COTININE | Cotinine (ng/mL) | TOBACCO ALKALOID | 300 | 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 | ||||
| TOB777 | 002 | 7 | COTGLUC | Cotinine-glucuronide (ng/mL) | TOBACCO ALKALOID | 275 | 275 | ng/mL | Tobacco Marker Testing Laboratory | URINE | 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | ||||||
| TOB777 | 002 | 8 | COXT | Cotinine-n-oxide (ng/mL) | TOBACCO ALKALOID | 117.5 | 117.5 | ng/mL | Tobacco Marker Testing Laboratory | URINE | HPLC-ESI-MS/MS | 2.02 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | |||||
| TOB777 | 002 | 9 | OHCOT or HCTT | Trans-3-hydroxycotinine (ng/mL) | TOBACCO ALKALOID | 2000 | 2000 | ng/mL | Tobacco Marker Testing Laboratory | 33916-8 | URINE | 0.1 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | |||||
| TOB777 | 002 | 10 | OHCOTG or 3HC-Gluc | Trans-3-hydroxycotinine glucuronide (ng/mL) | TOBACCO ALKALOID | 3529 | 3529 | ng/mL | Tobacco Marker Testing Laboratory | URINE | 0.03 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | ||||||
| TOB777 | 002 | 11 | NORNCTN or NNIC | Nornicotine (ng/mL) | TOBACCO ALKALOID | 6 | 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 | ||||
| TOB777 | 002 | 12 | ANBS | Anabasine (ng/mL) | TOBACCO ALKALOID | 5 | 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 | ||||
| TOB777 | 002 | 13 | NCOT | Norcotinine (ng/mL) | TOBACCO ALKALOID | 2 | 2 | ng/mL | Tobacco Marker Testing Laboratory | 77740-9 | URINE | 1.11 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | |||||
| TOB777 | 002 | 14 | ANTB | Anatabine (ng/mL) | TOBACCO ALKALOID | 9.1 | 9.1 | ng/mL | Tobacco Marker Testing Laboratory | URINE | HPLC-ESI-MS/MS | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | ||||||
| TOB777 | 2001 | 1 | OH_2_FLU or 2-FLU | 2-Hydroxyfluorene 3‐Hydroxyfluorene (3‐FLU) (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 30 | 30 | ng/mL | Tobacco Marker Testing Laboratory | 3853-9 | URINE | LC-MS/MS | 3853-9 | 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | ||||
| TOB777 | 2001 | 2 | OH1NAPHT | 1-Hydroxynaphthalene (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 400 | 400 | ng/mL | Tobacco Marker Testing Laboratory | 10365-5 | URINE | LC-MS/MS | 10365-5 | 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | ||||
| TOB777 | 2001 | 3 | OH1PHE | 1-Hydroxyphenanthrene (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 45 | 45 | ng/mL | Tobacco Marker Testing Laboratory | 3854-7 | URINE | LC-MS/MS | 3854-7 | 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | ||||
| TOB777 | 2001 | 4 | OH3BAP | 3-Hydroxybenzo[a]pyrene (ng/mL) | POLYNUCLEAR AROMATIC HYDROCARBON | 300 | 300 | ng/mL | Tobacco Marker Testing Laboratory | 10366-3 | URINE | LC-MS/MS | 10366-3 | 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | ||||
| TOB777 | 2001 | 5 | CO | Carbon Monoxide (%) | VARIOUS GASES | 10 | 10 | % | Tobacco Marker Testing Laboratory | EXPIRED AIR | Multiple Wavelength Spectrophotometer | 2 | Day 60 | 2021-09-15 |
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