This is an example of the SDTM LB dataset used to represent routine safety laboratory tests.
The LB dataset used the UNIT codelist for LBORRESU and LBORRESU. The LBLOINC variable contains a code from the LOINC database that identifies a specific laboratory test. The LOINC to LB Mapping Codetable (available at https://www.cdisc.org/standards/terminology/controlled-terminology) may be used to identify appropriate CDISC CT values for a test with a particular LOINC code.
LBNRIND was added to indicate where a result falls with respect to reference range defined by LBORNRLO and LBORNRHI. LBSTNRC was used to populated a normal range values that are character values for an ordinal scale (e.g., “NEGATIVE"). LBORNRLO, LBORNRHI, LBSTNRLO, and LBSTNRHI are null for these types of tests.
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| Jira |
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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-283 |
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| Rows 1-4: | Show records for common tests to evaluate hematology. The applicant used LBCAT (HEMATOLOGY) to group these tests. | | Rows 5, 7, 8: | Show records for common tests. LBCAT indicates the category assigned for these laboratory tests. | | Row 6: | Shows a value collected in 1 unit but converted to selected standard unit. | | Row 9: | Shows use of LBSTNRC for cannabinoids that is not reported as a continuous numeric result. The result was evaluated by the investigator and determined to be clinically significant |
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ROW | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRC | LBSTNRLO | LBSTNRHI | LBNRIND | LBLOINC | LBSPEC | LBLOBXFL | LBCLSIG | VISITNUM | LBDTC |
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| 1 | TBLB001 | LB | 001-001 | 1 | WBC | Leukocytes | HEMATOLOGY | 11.0 | 10^9/L | 4.5 | 11.0 | 11.0 | 11.0 | 10^9/L |
| 4.5 | 11.0 |
| 26464-8 | BLOOD | Y |
| 1 | 2020-12-01 | | 2 | TBLB001 | LB | 001-001 | 2 | RBC | RBC | HEMATOLOGY | 5.4 | 10^12/L | 4.7 | 6.1 | 5.4 | 5.4 | 10^12/L |
| 4.7 | 6.1 |
| 33051-4 | BLOOD | Y |
| 1 | 2020-12-01 | | 3 | TBLB001 | LB | 001-001 | 3 | PLAT | Platelets | HEMATOLOGY | 158 | 10^9/L | 150 | 400 | 158 | 158 | 10^9/L |
| 150 | 400 |
| 49497-1 | BLOOD | Y |
| 1 | 2020-12-01 | | 4 | TBLB001 | LB | 001-001 | 4 | HGB | Hemoglobin | HEMATOLOGY | 14.5 | g/dL | 14 | 18 | 14.5 | 14.5 | g/dL |
| 14 | 18 |
| 718-7 | BLOOD | Y |
| 1 | 2020-12-01 | | 5 | TBLB001 | LB | 001-001 | 5 | CHOL | Cholesterol | CLINICAL CHEMISTRY | 229 | mg/dL | 200 |
| 229 | 229 | mg/dL |
| 200 |
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| 2093-3 | BLOOD | Y |
| 1 | 2020-12-01 | | 6 | TBLB001 | LB | 001-001 | 6 | ALB | Albumin | CLINICAL CHEMISTRY | 40.0 | g/L | 34 | 54 | 4.0 | 4.0 | g/dL |
| 3.4 | 5.4 |
| 2862-1 | BLOOD | Y |
| 1 | 2020-12-01 | | 7 | TBLB001 | LB | 001-001 | 7 | CREAT | Creatinine | CLINICAL CHEMISTRY | 0.8 | mg/dL | 0.7 | 1.3 | 0.8 | 0.8 | mg/dl |
| 0.7 | 1.3 |
| 2160-0 | BLOOD | Y |
| 1 | 2020-12-01 | | 8 | TBLB001 | LB | 001-001 | 8 | SPGRAV | Specific Gravity | URINALYSIS | 1.002 |
| 1.005 | 1.030 |
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| 1.005 | 1.030 |
| 2965-2 | URINE | Y |
| 1 | 2020-12-01 | | 9 | TBLB001 | LB | 001-001 | 9 | CANNAB | Cannabinoids | DRUG TOXICITY | POSITIVE |
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| POSITIVE |
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| POSITIVE |
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| ABNORMAL | 18282-4 | URINE | Y | Y | 1 | 2020-12-01 |
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C-Reactive Protein (CRP),LDL),Fibrinogen,(IL-6), total cholesterol,triglycerides ,urinary cotinine test
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| Rows 1, 9: | Show that glucose was measured for approximately 24 hours, and the mean glucose value was represented in LBORRES/LBSTRESC. The collected summary result is represented in the NSV LBCOLSRT. LBTEST is "Plasma Equivalent Glucose" as the results represent a concentration of glucose. | | Rows 8, 16: | Show the GMI results calculated by the device based on glucose results collected during the 14-day period that ended on the day of each visit. The value of the LBANMETH variable indicates that the GMI results were calculated as a percentage based on mean glucose measurements reported in mg/dL. | | Rows 2-7, 10-15: | Show other statistics that were calculated by the CGM device from the raw glucose levels collected during the specified interval. Again, LBCOLSRT is used to indicate which summary statistic was calculated for the glucose values collected in this interval. LBTEST is "Plasma Equivalent Glucose Distribution" as these are tests about the distribution of the glucose measurements. | | Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | LBSEQ | LBTESTCD | LBTEST | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSPEC | LBMETHOD | LBANMETH | VISITNUM | VISIT | VISITDY | LBDTC | LBENDTC | LBDY | LBENDY | LBCOLSRT | 1 | T005 | LB | 001 | CGM-001 | 1 | | Plasma Equivalent Glucose | 113.7 | mg/dL | 113.7 | 113.7 | mg/dL | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 2 | WEEK 2 | 15 | | 2016-09-29T08:00 | 14 | 15 | MEAN | 2 | T005 | LB | 001 | CGM-001 | 2 | | Plasma Equivalent Glucose Distribution | 15 | 15 | 15 | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 2 | WEEK 2 | 15 | 2016-09-28T08:00 | 2016-09-29T08:00 | 14 | 15 | STANDARD DEVIATION | 3 | T005 | LB | 001 | CGM-001 | 3 | GLUCPED | Plasma Equivalent Glucose Distribution | 13.7 | 13.7 | 13.7 | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 2 | WEEK 2 | 15 | 2016-09-28T08:00 | 2016-09-29T08:00 | 14 | 15 | COEFFICIENT OF VARIATION | 4 | T005 | LB | 001 | CGM-001 | 4 | GLUCPED | Plasma Equivalent Glucose Distribution | 0 | % | 0 | 0 | % | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 2 | WEEK 2 | 15 | 2016-09-28T08:00 | 2016-09-29T08:00 | 14 | 15 | PROPORTION LOW | 5 | T005 | LB | 001 | CGM-001 | 5 | GLUCPED | Plasma Equivalent Glucose Distribution | 0 | % | 0 | 0 | % | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 2 | WEEK 2 | 15 | 2016-09-28T08:00 | 2016-09-29T08:00 | 14 | 15 | PROPORTION HIGH | 6 | T005 | LB | 001 | CGM-001 | 6 | GLUCPED | Plasma Equivalent Glucose Distribution | 100 | % | 100 | 100 | % | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 2 | WEEK 2 | 15 | 2016-09-28T08:00 | 2016-09-29T08:00 | 14 | 15 | PROPORTION WITHIN TARGET RANGE | 7 | T005 | LB | 001 | CGM-001 | 7 | GLUCPED | Plasma Equivalent Glucose Distribution | 0 | min | 0 | 0 | min | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 2 | WEEK 2 | 15 | 2016-09-28T08:00 | 2016-09-29T08:00 | 14 | 15 | TIME IN CRITICAL LOW RANGE | 8 | T005 | LB | 001 | CGM-001 | 8 | GMI | Glucose Management Indicator | 6.04 | % | 6.04 | 6.04 | % | INTERSTITIAL FLUID | CALCULATION | GMI % FORMULA | 2 | WEEK 2 | 15 | 2016-09-15T08:00 | 2016-09-29T08:00 | 1 | 15 | 9 | T005 | LB | 001 | CGM-001 | 9 | GLUCPE | Plasma Equivalent Glucose | 110.7 | mg/dL | 110.7 | 110.7 | mg/dL | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 10 | WEEK 52 | 365 | 2017-09-13T08:02 | 2017-09-14T07:57 | 364 | 365 | MEAN | 10 | T005 | LB | 001 | CGM-001 | 10 | GLUCPED | Plasma Equivalent Glucose Distribution | 15 | 15 | 15 | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 10 | WEEK 52 | 365 | 2017-09-13T08:02 | 2017-09-14T07:57 | 364 | 365 | STANDARD DEVIATION | 11 | T005 | LB | 001 | CGM-001 | 11 | GLUCPED | Plasma Equivalent Glucose Distribution | 13.7 | 13.7 | 13.7 | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 10 | WEEK 52 | 365 | 2017-09-13T08:02 | 2017-09-14T07:57 | 364 | 365 | COEFFICIENT OF VARIATION | 12 | T005 | LB | 001 | CGM-001 | 12 | GLUCPED | Plasma Equivalent Glucose Distribution | 0 | % | 0 | 0 | % | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 10 | WEEK 52 | 365 | 2017-09-13T08:02 | 2017-09-14T07:57 | 364 | 365 | PROPORTION LOW | 13 | T005 | LB | 001 | CGM-001 | 13 | GLUCPED | Plasma Equivalent Glucose Distribution | 0 | % | 0 | 0 | % | IINTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 10 | WEEK 52 | 365 | 2017-09-13T08:02 | 2017-09-14T07:57 | 364 | 365 | PROPORTION HIGH | 14 | T005 | LB | 001 | CGM-001 | 14 | GLUCPED | Plasma Equivalent Glucose Distribution | 100 | % | 100 | 100 | % | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 10 | WEEK 52 | 365 | 2017-09-13T08:02 | 2017-09-14T07:57 | 364 | 365 | PROPORTION WITHIN TARGET RANGE | 15 | T005 | LB | 001 | CGM-001 | 15 | GLUCPED | Plasma Equivalent Glucose Distribution | 0 | min | 0 | 0 | min | INTERSTITIAL FLUID | CALCULATION | DEVICE ALGORITHM | 10 | WEEK 52 | 365 | 2017-09-13T08:02 | 2017-09-14T07:57 | 364 | 365 | TIME IN CRITICAL LOW RANGE | 16 | T005 | LB | 001 | CGM-001 | 16 | GMI | Glucose Management Indicator | 5.93 | % | 5.93 | 5.93 | % | INTERSTITIAL FLUID | CALCULATION | GMI % FORMULA | 10 | WEEK 52 | 365 | 2017-08-31T08:02 | 2017-09-14T07:57 | 351 | 365 | | Nsvmeta |
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| | Variable | Label | Type | Role | Codelist | Origin |
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LBCOLSRT | Collected Summary Result Type | text | Non-standard Record Qualifier | (COLSTYP) | CRF |
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