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This example trial set dataset, tx.xpt, shows information about the test conditions for set A1 and A2 in this example study, 123. Set A1 and A2 can be seen in the first and second rows respectively of Table 1 in the Sample Report table for Study 123 (above). For brevity, the trial sets dataset, tx.xpt, and the findings dataset, gt.xpt do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.
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Rows 1-23: | Show trial set parameters and trial set values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0". Set A1 is associated with the first row in the sample report table for study 123. | Rows 24-46: | Show trial set parameters and trial set values that comprise the test conditions for trial set A2. Set A2 is the data for the short term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250". Set A2 is associated with the second row in the sample report table for study 123. |
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Dataset2 |
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Row | STUDYID | GNTXAID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | MNvit | TX | A1 | ST+S9_C0 | 2 | METACT | Metabolic Activation | +S9 | 2 | 123 | MNvit | TX | A1 | ST+S9_C0 | 3 | METACTFL | Y/N presence of metabolic activation | Y |
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3 | 123 | MNvit | TX | A1 | ST+S9_C0 | 4 | TRTDMIN | Treatment Duration Minimum | 3 |
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4 | 123 | MNvit | TX | A1 | ST+S9_C0 | 5 | TRTDTRG | Treatment Duration Target | 3.5 |
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5 | 123 | MNvit | TX | A1 | ST+S9_C0 | 6 | TRTDMAX | Treatment Duration Maximum | 4 |
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6 | 123 | MNvit | TX | A1 | ST+S9_C0 | 7 | TRTDU | Treatment Duration Unit | HOURS | 7 | 123 | MNvit | TX | A1 | ST+S9_C0 | 8 | RCVDMIN | Recovery Duration Minimum | 23.5 | 8 | 123 | MNvit | TX | A1 | ST+S9_C0 | 9 | RCVDTRG | Recovery Duration Target | 24 | 9 | 123 | MNvit | TX | A1 | ST+S9_C0 | 10 | RCVDMAX | Recovery Duration Maximum | 24.5 | 10 | 123 | MNvit | TX | A1 | ST+S9_C0 | 11 | RCVDU | Recovery Duration Unit | HOURS | 11 | 123 | MNvit | TX | A1 | ST+S9_C0 | 12 | INCBTMP | Incubation Temperature | 37 | 12 | 123 | MNvit | TX | A1 | ST+S9_C0 | 13 | INCBTMPU | Incubation Temperature Unit | C | 13 | 123 | MNvit | TX | A1 | ST+S9_C0 | 14 | HUMID | Atmospheric Relative Humidity Percent | 50 | 14 | 123 | MNvit | TX | A1 | ST+S9_C0 | 15 | ATMCO2 | Atmospheric CO2 Percent | 5 | 15 | 123 | MNvit | TX | A1 | ST+S9_C0 | 16 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | 16 | 123 | MNvit | TX | A1 | ST+S9_C0 | 17 | EXPTYP | | Submerged | 17 | 123 | MNvit | TX | A1 | ST+S9_C0 | 18 | SAMTYP | Sample Type | Total Particulate Matter in DMSO |
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18 | 123 | MNvit | TX | A1 | ST+S9_C0 | 19 | INTRVN | Name of the Intervention Article | Tobacco ProdA |
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19 | 123 | MNvit | TX | A1 | ST+S9_C0 | 20 | ITVTYPE | type of intervention article | Negative Control |
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20 | 123 | MNvit | TX | A1 | ST+S9_C0 | 21 | ITVCONC | Concentration of intervention article | 0 | 21 | 123 | MNvit | TX | A1 | ST+S9_C0 | 22 | ITVCONCU | Concentration Unit | ug/ml | 22 | 123 | MNvit | TX | A1 | ST+S9_C0 | 23 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3K |
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23 | 123 | MNvit | TX | A1 | ST+S9_C0 | 24 | DUREFID | Smoke Regimen | Medium Intensity Regimen |
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24 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 2 | METACT | Metabolic Activation | +S9 |
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25 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 3 | METACTFL | Y/N presence of metabolic activation | Y |
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26 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 4 | TRTDMIN | Treatment Duration Minimum | 3 | 27 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 5 | TRTDTRG | Treatment Duration Target | 3.5 | 28 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 6 | TRTDMAX | Treatment Duration Maximum | 4 | 29 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 7 | TRTDU | Treatment Duration Unit | HOURS | 30 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 8 | RCVDMIN | Recovery Duration Minimum | 23.5 | 31 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 9 | RCVDTRG | Recovery Duration Target | 24 | 32 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 10 | RCVDMAX | Recovery Duration Maximum | 24.5 | 33 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 11 | RCVDU | Recovery Duration Unit | HOURS | 34 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 12 | INCBTMP | Incubation Temperature | 37 | 35 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 13 | INCBTMPU | Incubation Temperature Unit | C | 36 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 14 | HUMID | Atmospheric Relative Humidity Percent | 50 | 37 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 15 | ATMCO2 | Atmospheric CO2 Percent | 5 |
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38 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 16 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
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39 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 17 | EXPTYP | | Submerged |
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40 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 18 | SAMTYP | Sample Type | Total Particulate Matter in DMSO | 41 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 19 | INTRVN | Name of the Intervention Article | Tobacco ProdA | 42 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 20 | ITVTYPE | type of intervention article | Product |
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43 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 21 | ITVCONC | Concentration of intervention article | 1250 |
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44 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 22 | ITVCONCU | Concentration Unit | ug/ml |
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45 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 23 | SPDEVID | Sponsor defined device identifier | PUFFMASTER2023 |
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46 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 24 | DUREFID | Smoke Regimen | High Intensity Regimen |
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Row 1: | Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of 'A1', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier is referring to both the experimental unit, the unit to which the treatment is applied, and the entire trial set. | Rows 2-5: | Show the values of four observational units C0_Count1 through C0_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt. | Row 6: | Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of 'A2', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier is referring to both the experimental unit, the unit to which the treatment is applied, and the entire trial set. | Rows 7-10: | Show the values of four observational units C1250_Count1 through C1250_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt. |
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Dataset2 |
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| Row | STUDYID | GNTXAID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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1 | 123 | MNvit | A1 | C0 |
| 1 | EXPERIMENTAL UNIT/TRIAL SET |
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2 | 123 | MNvit | A1 | C0-Count1 | C0 | 2 | OBSERVATIONAL UNIT |
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3 | 123 | MNvit | A1 | C0-Count2 | C0 | 2 | OBSERVATIONAL UNIT |
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4 | 123 | MNvit | A1 | C0-Count3 | C0 | 2 | OBSERVATIONAL UNIT |
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5 | 123 | MNvit | A1 | C0-Count4 | C0 | 2 | OBSERVATIONAL UNIT |
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6 | 123 | MNvit | A2 | C1250 |
| 1 | EXPERIMENTAL UNIT/TRIAL SET |
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7 | 123 | MNvit | A2 | C1250-Count1 | C1250 | 2 | OBSERVATIONAL UNIT | 8 | 123 | MNvit | A2 | C1250-Count2 | C1250 | 2 | OBSERVATIONAL UNIT | 9 | 123 | MNvit | A2 | C1250-Count3 | C1250 | 2 | OBSERVATIONAL UNIT | 10 | 123 | MNvit | A2 | C1250-Count4 | C1250 | 2 | OBSERVATIONAL UNIT |
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Rows 1-3, 8: | Show percentage result values that apply to REFID=C0. REFID=C0, as shown in the relref dataset, relates this data to the trial set in the first row of Table 1 in the sample report table for study 123. | Rows 4-7: | Show the four micronucleated cell counts for the observational units with REFID from C0-Count1 through C0-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the relref dataset. | Rows 9-11,16: | Show percentage result values that apply to REFID=C1250. REFID=C1250, as shown in the relref dataset, relates this data to the trial set in the second row of Table 1 in the sample report table for study 123. | Rows 12-15: | Show the four micronucleated cell counts for the observational units with REFID from C1250-Count1 through C1250-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the relref dataset. |
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Dataset2 |
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Row | STUDYID | GNTXAID | DOMAIN | REFID | GTSEQ | GTTESTCD | GTTEST | GTCELLEV | GTORRES | GTORRESU | GTCOLSRT | GTSTRESC | GTSTRESN | GTSTRESU | GTDTC |
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1 | 123 | MNvit | GT | C0 | 1 | RICC | Relative Increase in Cell Count | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | 2 | 123 | MNvit | GT | C0 | 2 | RCC | Relative Cell Count | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | 3 | 123 | MNvit | GT | C0 | 3 | RPD | Relative Population Doubling | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | 4 | 123 | MNvit | GT | C0-Count1 | 4 | MNCELLS | Micronucleated Cells | 2205 | 15 | Cells |
| 15 | 15 | Cells | 2022-05-25 | 5 | 123 | MNvit | GT | C0-Count2 | 5 | MNCELLS | Micronucleated Cells | 2474 | 13 | Cells |
| 13 | 13 | Cells | 2022-05-25 | 6 | 123 | MNvit | GT | C0-Count3 | 6 | MNCELLS | Micronucleated Cells | 2758 | 17 | Cells |
| 17 | 17 | Cells | 2022-05-25 | 7 | 123 | MNvit | GT | C0-Count4 | 7 | MNCELLS | Micronucleated Cells | 2669 | 12 | Cells |
| 12 | 12 | Cells | 2022-05-25 | 8 | 123 | MNvit | GT | C0 | 8 | AVGREL | Average Relative MN Frequency |
| 0.57 | % |
| 0.57 | 0.57 | % | 2022-05-25 | 9 | 123 | MNvit | GT | C1250 | 1 | RICC | Relative Increase in Cell Count | 134 | 15.7 | % |
| 15.7 | 15.7 | % | 2022-05-25 | 10 | 123 | MNvit | GT | C1250 | 2 | RCC | Relative Cell Count | 134 | 13.0 | % |
| 13.0 | 13.0 | % | 2022-05-25 | 11 | 123 | MNvit | GT | C1250 | 3 | RPD | Relative Population Doubling | 134 | 7.9 | % |
| 7.9 | 7.9 | % | 2022-05-25 | 12 | 123 | MNvit | GT | C1250-Count1 | 4 | MNCELLS | Micronucleated Cells | 3266 | 20 | Cells |
| 20 | 20 | Cells | 2022-05-25 | 13 | 123 | MNvit | GT | C1250-Count2 | 5 | MNCELLS | Micronucleated Cells | 2190 | 17 | Cells |
| 17 | 17 | Cells | 2022-05-25 | 14 | 123 | MNvit | GT | C1250-Count3 | 6 | MNCELLS | Micronucleated Cells | 2758 | 13 | Cells |
| 13 | 13 | Cells | 2022-05-25 | 15 | 123 | MNvit | GT | C1250-Count4 | 7 | MNCELLS | Micronucleated Cells | 2714 | 21 | Cells |
| 21 | 21 | Cells | 2022-05-25 | 16 | 123 | MNvit | GT | C1250 | 8 | AVGREL | Average Relative MN Frequency |
| 0.66 | % |
| 0.66 | 0.66 | % | 2022-05-25 |
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