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This is an example of a study where biomarkers were collected. All subjects participated in a baseline biomarker assessment and smokers were then switched to exclusive use of their assigned product. Subjects were directed to use their assigned product exclusively for 6 months with collection of samples for biomarker assessment at Day 1 (Visit 1, baseline), Day 90 (Visit 2) and Day 180 (Visit 3). Blood and 24 hour urine samples were collected at each visit. 

Many biomarkers were measured, only a few representative biomarkers are shown below. Note, that a value derived by a central lab according to the lab's procedures is considered collected rather than derived. Sometimes these biomarkers are normalized by dividing the concentration of the biomarker of interest by the urine creatinine concentration obtained in the same urine sample. The results then may be reported as the concentration of biomarker of interest per creatinine. This normalization process is usually represented in an ADaM dataset shown below. Normalization may also be done using the total urine volume in the collected sample. 

Controlled terminology was developed for the majority of biomarkers used in Tobacco studies, including biomarkers of harm. 

The variables LBORNRLO, LBORNRHI, LBSTNRLO, LBSTNRHI, LBNRIND and LBLOBXFL are expected variables. but are typically not used in these types of studies. Hence are included in the datset but the values may be null. These variables are not included below to save space.  

For lab tests where the specimen is collected over time (e.g., 24-hour urine collection), the start date/time of the collection represented in LBDTC and the end date/time of collection is represented in LBENDTC. LBDTC and LBENDTC dates are based on the specimen collection date. If the date of the assay is needed, it can be added as a non-standard variable.  

Selected rows are included for illustration purposes only, in order to save space. The LOINC code, if included, should be provided by the testing laboratory. The sponsor may also include the method used for testing if it is of interest.   

The biomarkers were categorized using LBCAT and LBSCAT. These categories were based on the scientific classification of the type of  biomarker and the associated constituent being evaluated by the biomarker test. Other categorization may be done by the sponssor, based on the study design. These may include using Biomarker of Tobacco Exposure, Biomarkers of Harm or Potential Harm, Biomarkers of Compliance, etc. The LBSCAT can be used to provide the type of markers (e.g., Tobacco Alkaloid, Polynuclear Aromatic Hydrocarbons, Tobacco Specific Nitrosammines)  or the health impact of the biomarker (e.g., cancer, cardiovascular disease, respiratory effects, reproductive problems, and addiction.

Total Nicotine equivalents (TNE-7) were calculated by the sponsor 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.  

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 is shown.
Rows 5-16:Show various biomarkers related to Tobacco Alkaloids. These were obtain 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.

lb.xpt

lb.xpt

RowSTUDYIDDOMAINUSUBJIDLBSEQLBTESTCDLBTESTLBCATLBSCATLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBNAMLBLOINCLBSPECLBMETHODLBLOBXFLLBLLOQVISITNUMVISITLBDTCLBENDTC
1TOB777LB0011NICOTINENicotineTOBACCO ALKALOIDNICOTINE30ng/mL3030ng/mLTobacco Marker Testing Laboratory3853-9SERUMLC/MS/MSY21BASELINE2021-01-17
2TOB777LB0012COTININECotinineTOBACCO ALKALOIDNICOTINE400ng/mL400400ng/mLTobacco Marker Testing Laboratory10365-5SERUMLC/MS/MS
23Day 1802021-07-20
3TOB777LB0021CREATCreatinine24-HOUR URINE TEST
0.8ng/mL0.80.8ng/mLTobacco Marker Testing Laboratory65634-8URINELC-MS-MSY
1BASELINE2021-06-21T08:002021-06-22T08:00
4TOB777LB0022VOLUMEVolume24-HOUR URINE TEST
1875mL18751875mLTobacco Marker Testing Laboratory
URINE
Y
1BASELINE2021-06-21T08:002021-06-22T08:00
5TOB777LB0023NICOTINENicotineTOBACCO ALKALOIDNICOTINE45ng/mL4545ng/mLTobacco Marker Testing Laboratory3854-7URINELC-MS/MS
0.23Day 1802021-12-15T08:002021-12-16T08:00
6TOB777LB0024NICGLUCNicotine-glucuronideTOBACCO ALKALOIDNICOTINE40ng/mL4040ng/mLTobacco Marker Testing Laboratory
URINE

0.23Day 1802021-12-15T08:002021-12-16T08:00
7TOB777LB0025NOXTNicotine-1 N-oxidTOBACCO ALKALOIDNICOTINE113.5ng/mL

ng/mLTobacco Marker Testing Laboratory
URINEHPLC-ESI-MS/MS
2.503Day 1802021-12-15T08:002021-12-16T08:00
8TOB777LB0026COTININECotinineTOBACCO ALKALOIDNICOTINE300ng/mL300300ng/mLTobacco Marker Testing Laboratory10366-3URINELC/MS/MS)
0.053Day 1802021-12-15T08:002021-12-16T08:00
9TOB777LB0027COTGLUCCotinine-glucuronideTOBACCO ALKALOIDNICOTINE275ng/mL275275ng/mLTobacco Marker Testing Laboratory
URINE

0.23Day 1802021-12-15T08:002021-12-16T08:00
10TOB777LB0028COXTCotinine-n-oxideTOBACCO ALKALOIDNICOTINE117.5ng/mL117.5117.5ng/mLTobacco Marker Testing Laboratory
URINEHPLC-ESI-MS/MS
2.023Day 1802021-12-15T08:002021-12-16T08:00
11TOB777LB0029OHCOT or HCTTTrans-3-hydroxycotinineTOBACCO ALKALOIDNICOTINE2000ng/mL20002000ng/mLTobacco Marker Testing Laboratory33916-8URINE

0.13Day 1802021-12-15T08:002021-12-16T08:00
12TOB777LB00210OHCOTG or 3HC-GlucTrans-3- hydroxycotinine glucuronideTOBACCO ALKALOIDNICOTINE3529ng/mL35293529ng/mLTobacco Marker Testing Laboratory
URINE

0.033Day 1802021-12-15T08:002021-12-16T08:00
13TOB777LB00211NORNCTN or NNICNornicotineTOBACCO ALKALOIDNICOTINE6ng/mL66ng/mLTobacco Marker Testing Laboratory33917-6URINELC/MS/MS
2.503Day 1802021-12-15T08:002021-12-16T08:00
14TOB777LB00212ANBSAnabasineTOBACCO ALKALOIDNICOTINE5ng/mL55ng/mLTobacco Marker Testing Laboratory33915-0URINELC/MS/MS
0.513Day 1802021-12-15T08:002021-12-16T08:00
15TOB777LB00213NCOTNorcotinineTOBACCO ALKALOIDNICOTINE2ng/mL22ng/mLTobacco Marker Testing Laboratory77740-9URINE

1.113Day 1802021-12-15T08:002021-12-16T08:00
16TOB777LB00214ANTBAnatabineTOBACCO ALKALOIDNICOTINE9.1ng/mL9.19.1ng/mLTobacco Marker Testing Laboratory
URINEHPLC-ESI-MS/MS

3Day 1802021-12-15T08:002021-12-16T08:00
17TOB777LB20011

OH_2_FLU

2-FLU

2-Hydroxyfluorene 3‐Hydroxyfluorene (3‐FLU)POLYNUCLEAR AROMATIC HYDROCARBONS
30ng/mL3030ng/mLTobacco Marker Testing  Laboratory 3853-9URINELC-MS/MS3853-9
2Day 60 2021-09-15T010:002021-09-16T009:20
18TOB777LB20012OH1NAPHT1-HydroxynaphthalenePOLYNUCLEAR AROMATIC HYDROCARBONS
400ng/mL400400ng/mLTobacco Marker Testing  Laboratory 10365-5URINELC-MS/MS10365-5
2Day 60 2021-09-15T010:002021-09-16T009:20
19TOB777LB20013OH1PHE

1-Hydroxyphenanthrene

POLYNUCLEAR AROMATIC HYDROCARBONS
45ng/mL4545ng/mLTobacco Marker Testing  Laboratory 3854-7URINELC-MS/MS3854-7
2Day 60 2021-09-15T010:002021-09-16T009:20
21TOB777LB20014OH3BAP3-Hydroxybenzo[a]pyrenePOLYNUCLEAR AROMATIC HYDROCARBONS
300ng/mL300300ng/mLTobacco Marker Testing  Laboratory 10366-3URINELC-MS/MS10366-3
2Day 60 2021-09-15T010:002021-09-16T009:20
22TOB777LB20015COCarbon MonoxideVARIOUS GASES
10%%105Tobacco Marker Testing Laboratory
EXPIRED AIRMultiple Wavelength Spectrophotometer.

2Day 60 2021-09-15

Dataset Debug Messages

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The 2 rows of supplb.xpt add qualifying information to the laboratory data collected (RDOMAIN = "LB"). IDVAR defines the key variable used to link this information to the LB data (LBSEQ). IDVARVAL specifies the value of the key variable within the parent LB record to which the SUPPLB record applies. The remaining columns specify the supplemental variables’ names (LBNVOID and LBNMVIOD, labels, values, origin.  

Row 1:Shows the subject had 4 voids during the 24-hour urine collection.
Row 2:Shows subject had 2 voids missed during the 24-hour urine collection.
$titleHtml

supplb.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1TOB777LB002LBSEQ2LBNVOIDNumber of Voids During Collection4CRF
2TOB777LB002LBSEQ2LBMISVOD

Number of Missed Voids During Collection

2CRF
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.



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