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Row | STUDYID | USUBJID | LBSEQ | PARAMCD | PARAM | PARCAT1 | AVAL | BASE | CHG | ABLFL | LBSTRESN | LBSTRESU | LBNAM | LBLOINC | LBSPEC | LBMETHOD | LBLOBXFL | LBLLOQ | VISITNUM | VISIT | LBDTC | LBENDTC |
---|
1 | 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 |
|
---|
2 | 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 |
|
---|
3 | 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 |
---|
4 | 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 |
---|
5 | 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 |
---|
6 | 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 |
---|
7 | 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 |
---|
8 | 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 |
---|
9 | 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 |
---|
10 | 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 |
---|
11 | 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 |
---|
12 | 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 |
---|
13 | 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 |
---|
14 | 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 |
---|
15 | 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 |
---|
16 | 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 |
---|
17 | 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 |
---|
18 | 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 |
---|
19 | 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 |
---|
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 |
---|
21 | 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 |
|
---|
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
---|
| 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 |