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Rows 1-23: | Show trial set parameters and 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 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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TRTCAS | Primary Treatment CAS Registry Number | TEMPORARILY UNAVAILABLE | Expand |
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title | Full SEND ts.xpt FOR REFERENCE |
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TSSEQTSGRPIDTSPARMCDTSPARMTSVALTSVALNFTSSSTYP | Study Type | REPEAT DOSE TOXICITY | 2 | TS | 1 | SPECIES | Species | RAT | 3 | TS | 1 | STRAIN | Strain/Substrain | FISCHER 344 | 4 | TS | 1 | SPLRNAM | Test Subject Supplier | HARLAN | 5 | TS | 1 | SDESIGN | Study Design | CROSSOVER | 6 | TS | 1 | ROUTE | Route of Administration | ORAL | 7 | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | 8 | TS | 1 | EXPSTDTC | Experimental Start Date | 2008-01-01 | 9 | TS | 1 | EXPENDTC | Experimental End Date | 2008-03-07 | 10 | TS | 1 | TRMSAC | Time to Terminal Sacrifice | P42D | 11 | TS | 1 | STSTDTC | Study Start Date | 2007-12-30 | 12 | TS | 1 | DOSDUR | Dosing Duration | P42D | 13 | TS | 1 | STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods | 14 | TS | 1 | SNDIGVER | SEND Implementation Guide Version | SEND IMPLEMENTATION GUIDE VERSION 3.2 | 15 | TS | 1 | SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 | 16 | TS | 1 | STCAT | Study Category | TOX | 17 | TS | 1 | SSPONSOR | Sponsor Organization | Example Sponsor Inc. | 18 | TS | 1 | SPREFID | Sponsor's Study Reference ID | NOT APPLICABLE | 19 | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name | 20 | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 | 21 | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA | 22 | TS | 1 | AGETXT | Age Text | 6-8 | 23 | TS | 1 | AGEU | Age Unit | WEEKS | 24 | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith | 25 | TS | 1 | TRT | Investigational Therapy or Treatment | Drug A | 26 | TS | 1 | 2 | TRTV | Treatment Vehicle | Saline | 27 | TS | 1 | 2 | TRTVDESC | Treatment Vehicle Structured Description | 100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W} | 28 | TS | 1 | GLPFL | GLP Flag | Y | 29 | TS | 1 | TRTCAS | Primary Treatment CAS Registry Number | TEMPORARILY UNAVAILABLE | | Expand |
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Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
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1 | TA | ARM01-Prod1 | Cigarette Smoke Condensate, 10 ug/mL | 1 | TREATMT | Treatment | 9 | 9 | SLS-110 | 1 | Expand |
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title | te.xpt (trial elements) |
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Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
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TE | TREATMT | Treatment | Expand |
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Red font (CT is coming!, POSITIVE CONTROL, VEHICLE CONTROL, etc.)
ARMCD. TREATMENT (element). SETCD
ARM01 TREATMT. CS-01. (Cigarette Smoke 10 ug/mL)
ARM01
TA.XPT
TRIAL ARMS
Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
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1 | TA | ARM01-Prod1 | Cigarette Smoke Condensate, 10 ug/mL | 1 | TREATMT | Treatment | 2 | TA | ARM02-Prod1 | Cigarette Smoke Condensate, 50 ug/mL | 1 | TREATMT | Treatment | 3 | TA | ARM03-Prod1 | Cigarette Smoke Condensate, 75 ug/mL | 1 | TREATMT | Treatment | 4 | TA | 4 | 1 | 5 | TA | 5 | 1 | 6 | TA | 6 | 1 | 7 | 7 | 1 | 8 | 8 | 1 | 9 | 9 | SLS-110 | 1 | 10 | ARM10 | SLS-200 | 1 | TE.XPT
TRIAL ELEMENTS
Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
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TE | TREATMT | Treatment | tx.spt
TRIAL SET
example: Each plate has a separate product
Product, Smoking Regime (e.g. Traditional combustible, ENDS), Smoke Fraction, etc.
https://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=969610#null
One study (Original sample of TK6 cells); (6 rows in GT)
Assay (MNT) (ran on 10 tobacco products)
3 assay/test conditions;
Treatment duration (2: ST, LT);
Presence of metabolic activation (2: presence, type)
Concentrations of product (6 of these: 0, x, y, z,..., +CNTL);
CytoTox % (3 different percentages from testing 1 portion of the original sample)
4 MN counts conducted (on 4 different portions of original sample?)
EID (5 of these, Count1 - Count4 and Cytotox): with many TX Parm codes
Cytotox: RICC, RIC, RPD, #cells
Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | 1 | TX | METACT | Metabolic Activation | +S9 | 2 | METACT | Metabolic Activation | -S9 | TRTDUR | Treatment Duration | Short Term | TRTDUR | Treatment Duration | Long Term (or 2 parm codes, # and unit) | PRDCONC | Concentration of product | 0 | PRDCONCU | Concentration Unit | ug/ml | Product | Product Name | Smoking Regime | Smoke Fraction | TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | ARMCD | Arm Code | CS-10 | TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | SPECIES | Species | Salmonella enterica | TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | STRAIN | Strain/Substrain | Salmonella enterica enterica | TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | PRODUCT | Product | product A | TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | REGIME | Smoking Regime | Traditional combustible | TX | CS-20 | Cigarette Smoke Condensate, 50 ug/mL | ARMCD | Arm Code | CS-20 | TX | CS-20 | Cigarette Smoke Condensate, 50 ug/mL | PRODUCT | Product | product A | ... | TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | TRTDOS | Dose Level | 100 | TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | TCNTRL | Control Type | POSITIVE CONTROL | TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | CNTLAG | Control Agent | SODIUM LAURYL SULPHATE | MTACTIND | Metabolic Activating Agent Name | +S9 | 2 | 123 | TX | A1 | ST+S9_C0 | 2 | METACTFL | Presence of Metabolic Activation Flag | Y | 3 | 123 | TX | A1 | ST+S9_C0 | 3 | IVTDMIN | In vitro Treatment Duration Minimum | 3 | 4 | 123 | TX | A1 | ST+S9_C0 | 4 | IVTDTRG | In vitro Treatment Duration Target | 3.5 | 5 | 123 | TX | A1 | ST+S9_C0 | 5 | IVTDMAX | In vitro Treatment Duration Maximum | 4 | 6 | 123 | TX | A1 | ST+S9_C0 | 6 | IVTDU | In vitro Treatment Duration Unit | HOURS | 7 | 123 | TX | A1 | ST+S9_C0 | 7 | RCVDMIN | Recovery Duration Minimum | 23.5 | 8 | 123 | TX | A1 | ST+S9_C0 | 8 | RCVDTRG | Recovery Duration Target | 24 | 9 | 123 | TX | A1 | ST+S9_C0 | 9 | RCVDMAX | Recovery Duration Maximum | 24.5 | 10 | 123 | TX | A1 | ST+S9_C0 | 10 | RCVDU | Recovery Duration Unit | HOURS | 11 | 123 | TX | A1 | ST+S9_C0 | 11 | INCBTMP | Incubation Temperature | 37 | 12 | 123 | TX | A1 | ST+S9_C0 | 12 | INCBTMPU | Incubation Temperature Unit | C | 13 | 123 | TX | A1 | ST+S9_C0 | 13 | ATMRHP | Atmospheric Relative Humidity Percent | 50 | 14 | 123 | TX | A1 | ST+S9_C0 | 14 | ATMCO2P | Atmospheric CO2 Percent | 5 | 15 | 123 | TX | A1 | ST+S9_C0 | 15 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 16 | 123 | TX | A1 | ST+S9_C0 | 16 | EXPTYP | | Submerged | 17 | 123 | TX | A1 | ST+S9_C0 | 17 | SAMTYP | Sample Type | Total Particulate Matter in DMSO | 18 | 123 | TX | A1 | ST+S9_CO | 18 | ITVNAM | Intervention Article Name | Tobacco ProdA | 19 | 123 | TX | A1 | ST+S9_C0 | 19 | ITVTYPE | Intervention Article Type | Negative Control | 20 | 123 | TX | A1 | ST+S9_C0 | 20 | ITVCONC | Intervention Article Concentration | 0 | 21 | 123 | TX | A1 | ST+S9_C0 | 21 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 22 | 123 | TX | A1 | ST+S9_C0 | 22 | SPDEVID | Applicant-defined device identifier | PUFFMASTER3K | 23 | 123 | TX | A1 | ST+S9_C0 | 23 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 24 | 123 | TX | A2 | ST+S9_C1250 | 24 | MTACTIND | Metabolic Activating Agent Name | +S9 | 25 | 123 | TX | A2 | ST+S9_C1250 | 25 | METACTFL | Presence of Metabolic Activation Flag | Y | 26 | 123 | TX | A2 | ST+S9_C1250 | 26 | IVTDMIN | In vitro Treatment Duration Minimum | 3 | 27 | 123 | TX | A2 | ST+S9_C1250 | 27 | IVTDTRG | In vitro Treatment Duration Target | 3.5 | 28 | 123 | TX | A2 | ST+S9_C1250 | 28 | IVTDMAX | In vitro Treatment Duration Maximum | 4 | 29 | 123 | TX | A2 | ST+S9_C1250 | 29 | IVTDU | In vitro Treatment Duration Unit | HOURS | 30 | 123 | TX | A2 | ST+S9_C1250 | 30 | RCVDMIN | Recovery Duration Minimum | 23.5 | 31 | 123 | TX | A2 | ST+S9_C1250 | 31 | RCVDTRG | Recovery Duration Target | 24 | 32 | 123 | TX | A2 | ST+S9_C1250 | 32 | RCVDMAX | Recovery Duration Maximum | 24.5 | 33 | 123 | TX | A2 | ST+S9_C1250 | 33 | RCVDU | Recovery Duration Unit | HOURS | 34 | 123 | TX | A2 | ST+S9_C1250 | 34 | INCBTMP | Incubation Temperature | 37 | 35 | 123 | TX | A2 | ST+S9_C1250 | 35 | INCBTMPU | Incubation Temperature Unit | C | 36 | 123 | TX | A2 | ST+S9_C1250 | 36 | ATMRHP | Atmospheric Relative Humidity Percent | 50 | 37 | 123 | TX | A2 | ST+S9_C1250 | 37 | ATMCO2P | Atmospheric CO2 Percent | 5 | 38 | 123 | TX | A2 | ST+S9_C1250 | 38 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 39 | 123 | TX | A2 | ST+S9_C1250 | 39 | EXPTYP | | Submerged | 40 | 123 | TX | A2 | ST+S9_C1250 | 40 | SAMTYP | Sample Type | Total Particulate Matter in DMSO | 41 | 123 | TX | A2 | ST+S9_C1250 | 41 | ITVNAM | Intervention Article Name | Tobacco ProdA | 42 | 123 | TX | A2 | ST+S9_C1250 | 42 | ITVTYPE | Intervention Article Type | Product | 43 | 123 | TX | A2 | ST+S9_C1250 | 43 | ITVCONC | Intervention Article Concentration | 1250 | 44 | 123 | TX | A2 | ST+S9_C1250 | 44 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 45 | 123 | TX | A2 | ST+S9_C1250 | 45 | SPDEVID | Applicant-defined Device Identifier | PUFFMASTER2023 | 46 | 123 | TX | A2 | ST+S9_C1250 | 46 | SMKRGM | Smoking Regimen | HIGH INTENSITY REGIMEN |
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Rows 1-3, 8: | Show percentage result values that apply to GTREFID=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 4 micronucleated cell counts for the observational units with GTREFID 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 GTREFID=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 4 micronucleated cell counts for the observational units with GTREFID 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 | DOMAIN | GTSEQ | GTREFID | GTTESTCD | GTTEST | GTCELLEV | GTORRES | GTORRESU | GTCOLSRT | GTSTRESC | GTSTRESN | GTSTRESU | GTDTC |
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1 | 123 | GT | 1 | C0 | | Relative Increase in Cell Count | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | 2 | 123 | GT | 2 | C0 | RCC | Relative Cell Count | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | 3 | 123 | GT | 3 | C0 | RPD | Relative Population Doubling | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | 4 | 123 | GT | 4 | C0-Count1 | MNCE | Micronucleated Cells | 2205 | 15 | |
| 15 | 15 |
| 2022-05-25 | 5 | 123 | GT | 5 | C0-Count2 | MNCE | Micronucleated Cells | 2474 | 13 |
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| 13 | 13 |
| 2022-05-25 | 6 | 123 | GT | 6 | C0-Count3 | MNCE | Micronucleated Cells | 2758 | 17 |
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| 17 | 17 |
| 2022-05-25 | 7 | 123 | GT | 7 | C0-Count4 | MNCE | Micronucleated Cells | 2669 | 12 |
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| 12 | 12 |
| 2022-05-25 | 8 | 123 | GT | 8 | C0 | MNCECE | Micronucleated Cells/Total Cells |
| 0.57 | % |
| 0.57 | 0.57 | % | 2022-05-25 | 9 | 123 | GT | 1 | C1250 | RICC | Relative Increase in Cell Count | 134 | 15.7 | % |
| 15.7 | 15.7 | % | 2022-05-25 | 10 | 123 | GT | 2 | C1250 | RCC | Relative Cell Count | 134 | 13.0 | % |
| 13.0 | 13.0 | % | 2022-05-25 | 11 | 123 | GT | 3 | C1250 | RPD | Relative Population Doubling | 134 | 7.9 | % |
| 7.9 | 7.9 | % | 2022-05-25 | 12 | 123 | GT | 4 | C1250-Count1 | MNCE | Micronucleated Cells | 3266 | 20 |
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| 20 | 20 |
| 2022-05-25 | 13 | 123 | GT | 5 | C1250-Count2 | MNCE | Micronucleated Cells | 2190 | 17 |
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| 17 | 17 |
| 2022-05-25 | 14 | 123 | GT | 6 | C1250-Count3 | MNCE | Micronucleated Cells | 2758 | 13 |
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| 13 | 13 |
| 2022-05-25 | 15 | 123 | GT | 7 | C1250-Count4 | MNCE | Micronucleated Cells | 2714 | 21 |
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| 21 | 21 |
| 2022-05-25 | 16 | 123 | GT | 8 | C1250 | MNCECE | Micronucleated Cells/Total Cells |
| 0.66 | % |
| 0.66 | 0.66 | % | 2022-05-25 |
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TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | CNTLAGAMT | Control Agent amount (levels) | 110 | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | CNTLAGUNIT | Control Agent Unit | ug/mL | Expand |
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Row | STUDYID | DOMAIN | ENID (Entity ID) | RICC | RCC | RPD | Sum of cell ev. | Cells with MN | SMKFID (Smoke Fraction) | REPLCTID (Replicate Number) | PLATEID (Plate ID) | COLID (Column number) | ROWID (Row number) | SETCD (Set Code, TX) | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFCSTDTC | RFCENDTC | ARMCD | 1 | MA99999 | GT | 030001 | A | 1 | 1 | 1 | A | CS-10 | 2008-04-01T06:00 | | 2008-04-02T14:00 | 2008-04-02T14:04 | 2008-04-01T06:00 | 2008-04-01T06:00 | 3 | 2 | MA99999 | GT | 1 | 1-1 | 030001 | A | 1 | 1 | 1 | B | CS-10 | 2008-04-01T06:00 | 2008-04-21T14:00 | 2008-04-02T20:00 | 2008-04-02T20:04 | 2008-04-01T06:00 | 2008-04-01T06:00 | 3 | 2 | 3 | 4 | Expand |
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title | gt.xpt (similar to LB) |
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| Row | STUDYID | DOMAIN | TXCD | GTSEQ | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTSTRESC | GTSTRESN | GTSTRESU | GTCELLEV (cells evaluated) | GTSPEC??? | GTMETHOD | GTDTC | GTDY | GTNOMDY | GTELTM | GTTPTREF | 1 | ST487-12 | GT | RICC | ug/mL | ug/mL | 25-05-2022 | 2 | ST487-12 | GT | RCC | ug/mL | ug/mL | 3 | ST487-12 | GT | RPD | ug/mL | ug/mL | 4 | ST487-12 | GT | CELLS | Sum of cells evaluated | ug/mL | ug/mL | 5 | ST487-12 | GT | MNNUM | Cells with Micronuclei | ug/mL | ug/mL | 6 | ST487-12 | GT | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | 7 | ST487-12 | GT | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | 8 | ST487-12 | GT | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | 9 | ST487-12 | GT | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL
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