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Total Nicotine equivalents (TNE-7) were calculated by the applicant based on the data below and represented in an ADaM dataset. Total Nicotine equivalents are the sum of nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates. Other estimates of TNE can be used and are typically denoted using terms like TE-2, TE-3. For example TE-2 is the sum of cotinine + 3'-hydroxycotinine.
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-285 |
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| Rows 1-2: | Show the nicotine and cotinine measurements from a serum blood sample. These tests were performed at every visit but only the nicotine results at Visit 1, and the cotinine results at Visit 3 are shown. | | Rows 3-4: | Urine creatinine and 24-hour urine volume are shown. | | Rows 5-16: | Show various biomarkers whihc were categorizied as TOBACCO ALKALOID in LBCAT. These were obtained from a planned 24-hour urine sample. The start and end time of the urine collection are provided in LBDTC and LBENDTC. Only the results from Day 180 are shown. | | Rows 17-22: | Show various biomarkers which were categorized as POLYNUCLEAR AROMATIC HYDROCARBON in LBCAT. Only results from Day 60 are shown. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBSCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBNAM | LBLOINC | LBSPEC | LBMETHOD | LBLOBXFL | LBLLOQ | VISITNUM | VISIT | LBDTC | LBENDTC |
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| 1 | TOB777 | LB | 001 | 1 | NICOTINE | Nicotine | TOBACCO ALKALOID | NICOTINE | 30 | ng/mL | 30 | 30 | ng/mL | Tobacco Marker Testing Laboratory, Inc. | 3853-9 | SERUM | LC/MS/MS | Y | 2 | 1 | BASELINE | 2021-01-17 |
| | 2 | TOB777 | LB | 001 | 2 | COTININE | Cotinine | TOBACCO ALKALOID | NICOTINE | 400 | ng/mL | 400 | 400 | ng/mL | Tobacco Marker Testing Laboratory, Inc. | 10365-5 | SERUM | LC/MS/MS |
| 2 | 3 | Day 180 | 2021-07-20 |
| | 3 | TOB777 | LB | 002 | 1 | CREAT | Creatinine | 24-HOUR URINE TEST |
| 0.8 | ng/mL | 0.8 | 0.8 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | LC-MS-MS | Y |
| 1 | BASELINE | 2021-06-21T08:00 | 2021-06-22T08:00 | | 4 | TOB777 | LB | 002 | 2 | VOLUME | Volume | 24-HOUR URINE TEST |
| 1875 | mL | 1875 | 1875 | mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE |
| Y |
| 1 | BASELINE | 2021-06-21T08:00 | 2021-06-22T08:00 | | 5 | TOB777 | LB | 002 | 3 | NICOTINE | Nicotine | TOBACCO ALKALOID | NICOTINE | 45 | ng/mL | 45 | 45 | ng/mL | Tobacco Marker Testing Laboratory, Inc. | 3854-7 | URINE | LC-MS/MS |
| 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 6 | TOB777 | LB | 002 | 4 | NICGLUC | Nicotine-glucuronide | TOBACCO ALKALOID | NICOTINE | 40 | ng/mL | 40 | 40 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE |
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| 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 7 | TOB777 | LB | 002 | 5 | NOXT | Nicotine-1 N-oxide | TOBACCO ALKALOID | NICOTINE | 113.5 | ng/mL | 113.5 | 113.5 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | HPLC-ESI-MS/MS |
| 2.50 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 8 | TOB777 | LB | 002 | 6 | COTININE | Cotinine | TOBACCO ALKALOID | NICOTINE | 300 | ng/mL | 300 | 300 | ng/mL | Tobacco Marker Testing Laboratory, Inc. | 10366-3 | URINE | LC/MS/MS) |
| 0.05 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 9 | TOB777 | LB | 002 | 7 | COTGLUC | Cotinine-glucuronide | TOBACCO ALKALOID | NICOTINE | 275 | ng/mL | 275 | 275 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE |
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| 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 10 | TOB777 | LB | 002 | 8 | COXT | Cotinine-n-oxide | TOBACCO ALKALOID | NICOTINE | 117.5 | ng/mL | 117.5 | 117.5 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | HPLC-ESI-MS/MS |
| 2.02 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 11 | TOB777 | LB | 002 | 9 | T3HCT | Trans-3-Hydroxycotinine | TOBACCO ALKALOID | NICOTINE | 2000 | ng/mL | 2000 | 2000 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE |
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| 0.1 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 12 | TOB777 | LB | 002 | 10 | T3OHCOTG | Trans-3-Hydroxycotinine Glucuronide | TOBACCO ALKALOID | NICOTINE | 3529 | ng/mL | 3529 | 3529 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE |
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| 0.03 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 13 | TOB777 | LB | 002 | 11 | NORNCTN | Nornicotine | TOBACCO ALKALOID | NICOTINE | 6 | ng/mL | 6 | 6 | ng/mL | Tobacco Marker Testing Laboratory, Inc. | 33917-6 | URINE | LC/MS/MS |
| 2.50 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 14 | TOB777 | LB | 002 | 12 | ANABASN | Anabasine | TOBACCO ALKALOID | NICOTINE | 5 | ng/mL | 5 | 5 | ng/mL | Tobacco Marker Testing Laboratory, Inc. | 33915-0 | URINE | LC/MS/MS |
| 0.51 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 15 | TOB777 | LB | 002 | 13 | NORCOTN | Norcotinine | TOBACCO ALKALOID | NICOTINE | 2 | ng/mL | 2 | 2 | ng/mL | Tobacco Marker Testing Laboratory, Inc. | 77740-9 | URINE |
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| 1.11 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 16 | TOB777 | LB | 002 | 14 | ANATABN | Anatabine | TOBACCO ALKALOID | NICOTINE | 9.1 | ng/mL | 9.1 | 9.1 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | HPLC-ESI-MS/MS |
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| 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 17 | TOB777 | LB | 2001 | 1 | OHFLRN2 | 2-Hydroxyfluorene | POLYNUCLEAR AROMATIC HYDROCARBON |
| 30 | ng/mL | 30 | 30 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | LC-MS/MS |
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| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 18 | TOB777 | LB | 2001 | 2 | OHNPHTH1 | 1‐Hydroxynaphthalene | POLYNUCLEAR AROMATIC HYDROCARBON |
| 400 | ng/mL | 400 | 400 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | LC-MS/MS |
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| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 19 | TOB777 | LB | 2001 | 3 | OHPHNTR1 | 1-Hydroxyphenanthrene | POLYNUCLEAR AROMATIC HYDROCARBON |
| 45 | ng/mL | 45 | 45 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | LC-MS/MS |
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| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 21 | TOB777 | LB | 2001 | 4 | OHBZAPY3 | 3-Hydroxybenzo[a]pyrene | POLYNUCLEAR AROMATIC HYDROCARBON |
| 300 | ng/mL | 300 | 300 | ng/mL | Tobacco Marker Testing Laboratory, Inc. |
| URINE | LC-MS/MS |
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| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 22 | TOB777 | LB | 2001 | 5 | CMONOX | Carbon Monoxide | VARIOUS GASES |
| 10 | % | 10 | 10 | % | Tobacco Marker Testing Laboratory, Inc. |
| EXPIRED AIR | Multiple Wavelength Spectrophotometer |
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| 2 | Day 60 | 2021-09-15 |
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