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CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden |
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LBCAT | 1 | What was the name of the lab panel? | Lab Panel Name | Record the lab test category, if not pre-printed on the CRF. | Text | LBCAT |
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| HEMATOLOGY | Prompt |
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| LBSCAT | 2 | What was name of the lab sub-panel? | Lab Sub-Panel Name | Record the lab test subcategory, if not pre-printed on the CRF. | Text | LBSCAT |
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| COAGULATION | Prompt |
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| LBPERF | 3 | Was the lab performed? | Lab Performed | Indicate whether or not lab specimen was collected or measurement performed. | Text | LBSTAT | LBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y" | (NY) | Yes; No |
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| LBDAT | 4 | What was the date of the lab specimen collection? | Specimen Collection Date | Record the date of specimen collection using this format (DD-MON-YYYY). | Date | LBDTC |
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| LBTIM | 5 | What was the time of the lab specimen collection? | Specimen Collection Time | Record time of collection (as complete as possible). | Time | LBDTC |
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| LBSPCCND | 6 | What was the condition of the specimen? | Specimen Condition | Record condition of specimen. | Text | LBSPCCND |
| (SPECCOND) | FRESH; FROZEN; REFRIGERATED |
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| LBNAM | 7 | What was the name of the laboratory used? | Laboratory Name | Record the laboratory name. | Text | LBNAM |
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| LBTEST | 8 | What is the lab test name? | Lab Test Name | Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended. | Text | LBTEST; LBTESTCD | LBTEST and LBTESTCD | (LBTEST) | Prothrombin Intl. Normalized Ratio; Activated Partial Thromboplastin Time; Prothrombin Time; Thrombin Time; Fibrinogen; D-Dimer; Factor V; Factor VIII |
| Prompt | Radio |
| LBMETHOD | 9 | What was the method used for the lab test or examination? | Method of Test | Record the method of the test or examination. | Text | LBMETHOD |
| (METHOD) | CLAUSS METHOD; CLOT DETECTION; MANUAL CLOT DETECTION; MECHANICAL CLOT DETECTION; PHOTOMETRIC CLOT DETECTION |
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| LBORRES | 10 | What was the result of the lab test? | Result | Record laboratory test result. | Text | LBORRES |
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| LBORRESU | 11 | What was the unit of the lab result? | Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | LBORRESU |
| (UNIT) | g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO |
| Prompt | Radio |
| LBORNRLO | 12 | What was the lower limit of the reference range for this lab test? | Normal Range Lower Limit | Record the lower limit of the reference range of the lab test. | Text | LBORNRLO |
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| LBORNRHI | 13 | What was the high limit of the reference range for this lab test? | Normal Range Upper Limit | Record the upper limit of the reference range of the lab test. | Text | LBORNRHI |
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| LBNRIND | 14 | How do the reported values compare within the reference range? | Comparison to Reference Range | Record where the lab result fell with respect to the reference range (i.e., HIGH, NORMAL, LOW). | Text | LBNRIND |
| (NRIND) | High; Normal; Low |
| Prompt | Radio |
| LBCLSIG | 15 | Was this result clinically significant? | Clinically Significant | Record whether lab results were clinically significant. | Text | SUPPLB.QVAL | SUPPLB.QVAL where SUPPLB.QNAM = "LBCLSIG" and SUPPLB.QLABEL = "Clinically Significant" | (NY) | Yes; No |
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| LBTOXGR | 16 | What is the Toxicity Grade? | Toxicity Grade | Record the toxicity grade. | Text | LBTOXGR |
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| 0; 1; 2; 3; 4 |
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| LBTOX | 17 | What is the description of the toxicity? | Toxicity | Record the description of the toxicity. | Text | LBTOX |
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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. |
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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 |
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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 |
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| 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 |
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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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