This is an example showing trial design and results data of Study #123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay
| Expand |
|---|
|
| Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| | 1 |
|
| TA | ARM01-Prod1 | Cigarette Smoke Condensate, 10 ug/mL | 1 | TREATMT | Treatment | | 9 |
|
|
| 9 | SLS-110 | 1 |
|
| |
| Expand |
|---|
| title | te.xpt (trial elements) |
|---|
|
| Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
|---|
|
|
| TE | TREATMT | Treatment |
|
| Expand |
|---|
|
| Expand |
|---|
| 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 |
|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| | 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 |
|---|
|
|
| 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 | Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
|---|
| 1 |
|
|
| CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| METACT | Metabolic Activation | +S9 | | 2 |
|
|
| CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| METACT | Metabolic Activation | -S9 |
|
|
|
|
|
|
|
|
|
|
|
|
| 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 |
|
|
| 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 |
|---|
|
| Row | STUDYID | DOMAIN | ENID (Entity ID) | ST vs. LT | Activation (+S9, -S9) |
|
|
| RUNID (Run-Port Number) | SMPID (Sample ID) | 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 | EI | 1 |
|
|
|
|
| 1-1 | 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 | EI | 2 |
|
|
|
|
| 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 |
|
|
| Expand |
|---|
|
 Image Added
|
| Expand |
|---|
| title | Notes for creating GT domain |
|---|
|
- Entity ID links to EI domain (usubjid)
- TEST: After ST exposure to increasing concentrations of test article in the presence of S9 mix
|
| Expand |
|---|
| title | gt.xpt (similar to LB) |
|---|
|
| Row | STUDYID | DOMAIN | ENID (Entity ID) | GTSEQ | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTSTRESC | GTSTRESN | GTSTRESU | GTSPEC??? | GTMETHOD | GTDTC | GTDY | GTNOMDY | GTELTM | GTTPTREF |
|---|
| 1 | ST487-12 | GT | 1 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 2 | ST487-12 | GT | 2 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 3 | ST487-12 | GT | 3 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 4 | ST487-12 | GT | 4 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 5 | ST487-12 | GT | 5 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 6 | ST487-12 | GT | 6 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 7 | ST487-12 | GT | 7 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 8 | ST487-12 | GT | 8 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
| | 9 | ST487-12 | GT | 9 |
| MNT | In vitro Micronucleus Assay |
| ug/mL |
|
| ug/mL |
|
|
|
|
|
|
|
|