This example shows a report table, trial design, and results data for in vitro Neutral Red Cytotoxicity Assay, Relative Absorbance.
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Neutral Red Uptake Assay for Mainstream Tobacco Smoke: The neutral red uptake assay provides a quantitative estimation of the number of viable cells in a culture. It is one of the most used cytotoxicity tests with many biomedical and environmental applications. It is based on the ability of viable cells to incorporate and bind the supravital dye neutral red in the lysosomes. Note that Variable Names and Domain abbreviations may change (have not been checked against existing and are not vetted)- red font - indicates potential for CT code lists
- green font - links to other domains
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the in vitro neutral red uptake (NRU) cytotoxicity assay in example study 123.
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| title | Sample from Report Table |
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The following shows example data for study 123 in a report table. This report includes summary statistics (i.e., average, standard deviation, coefficient variation) for each plate and an EC50 value for the entire assay. In the table below, the light grey shading for plate 1 are values from wells that do not contain the NHK cells. The dark grey shading represents the column and row location within the 96-well plate, and in this example the applicant chose to use these column and row locations to assign their REFID values in the RELREF dataset and GT dataset. For brevity, the datasets in this example are not comprehensive but are intended to demonstrate a range of proper use. |
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| title | Study 123, Report Table |
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The following shows the tabulated data as shown in the report for this study:
Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data) |
Run-Port Number | FractionRegime | Replicate Number | Plate |
NumberWell Number |
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| Relative Assay Plate Absorbance Readings |
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| Cigarette Smoke Condensate (µg/mL) | SLS (µg/mL) |
| EC50 (µg/ml) | Well Column: | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
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Row: | 0 | 10 | 50 | 75 | 100 | 120 | 140 | 160 | 200 | 110 | 200 |
1-1A1 | 100 | 83.0 | 56.7 | 29.5 | 13.0 | 8.57 | 4.44 | 1.76 | 13.7 | 0.547 | A | 0.046*
| 0.046* | 0.039* | 0.012* | 0.030* | 0.003* | 0.057* | 0.032* | 0.003* | 0.050* | 0.044* | 0.040* |
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| 030001 | Medium | 1 | 1 | B | 0.048* |
1-1 | 030001 | A | 1 | 1 | 2 | 107 | 77.7 | 65.7 | 30.2 | 15.6 | 9.79 | 5.41 | 2.49 | 8.09 | 0.791 |
1-1A3C | 0.005* | 98.6 | 77.4 | 57.7 | 35.8 | 8.09 | 7.36 | 3.22 | 0.791 | 6.38 | 0.061 |
1-1A4 | 94.9 | 81.5 | 38.2 | 31.2 | 7.60 | 5.17 | 3.22 | 0.791 | 5.17 | 0.304 |
1-1A5E | 0.047* | 111 | 78.1 | 64.5 | 32.9 | 8.82 | 5.90 | 2.74 | 1.28 | 10.3 | 0.547 |
1-1A6F | 0.032* | 96.6 | 76.2 | 48.0 | 26.8 | 7.84 | 4.20 | 2.74 | 1.52 | 8.09 | 4.93 |
1-1A7G | 0.044* | 105 | 77.9 | 58.2 | 28.3 | 8.09 | 4.68 | 1.76 | 0.547 | 8.57 | 1.76 |
1-1A89527447.2 | 24.4 | 8.57 | 3.71 | 3.47 | 0.304 | 11.2 | | .040* | 0.008* | 0.013* | 0.002* | 0.029* | 0.018* | 0.006* | 0.016* | 0.024* | 0.046* |
0.791 |
| Average |
| 101 | 78.2 | 54.5 | 29.9 | 9.70 | 6.17 | 3.37 | 1.19 | 8.94 | 1.22 |
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| Std. Dev. |
| 6 | 2.9 | 9.4 | 3.6 | 2.95 | 2.19 | 1.12 | 0.72 | 2.72 | 1.58 |
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| Coeff. Var. |
| 5.8 | 3.6 | 17.2 | 11.9 | 30.4 | 35.5 | 33.1 | 61.0 | 30.5 | 129.9 |
1-1
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| *media without cells |
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| 030001 |
A1A |
| 93.4 | 74.0 | 56.0 | 35.1 | 11.8 | 8.70 | 5.10 | 1.98 | 5.34 | 1.02 |
1-1030001A | 2B |
| 102 | 75.2 | 53.3 | 35.1 | 11.8 | 7.74 | 5.58 | 3.66 | 5.34 | 1.02 |
1-1A3C |
| 107 | 79.0 | 55.0 | 26.5 | 10.1 | 6.06 | 3.66 | 1.74 | 7.02 | 0.780 |
1-1 | A4D |
| 104 | 80.2 | 55.3 | 29.8 | 8.94 | 3.90 | 3.66 | 1.50 | 6.30 | 0.780 |
1-1 | A5E |
| 101 | 75.7 | 54.1 | 26.7 | 4.86 | 4.38 | 1.26 | 1.02 | 6.30 | 1.02 |
1-1A6F |
| 110 | 85.7 | 67.7 | 26.0 | 5.34 | 4.62 | 3.42 | 1.50 | 6.30 | 0.540 |
1-1A7G |
| 104 | 77.8 | 64.9 | 27.7 | 8.22 | 3.18 | 2.46 | 1.02 | 6.30 | 0.780 |
1-1 | A8H |
| 103 | 71.6 | 58.9 | 25.5 | 9.42 | 4.14 | 3.90 | 1.26 | 4.38 | 0.780 |
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| Average |
| 103 | 77.4 | 58.1 | 29.0 | 8.82 | 5.34 | 3.63 | 1.71 | 5.91 | 0.840 |
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| Std. Dev. |
| 5 | 4.4 | 5.3 | 4.0 | 2.63 | 1.97 | 1.37 | 0.86 | 0.83 | 0.170 |
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| Coeff. Var. |
| 4.6 | 5.6 | 9.2 | 13.6 | 29.8 | 36.9 | 37.6 | 50.0 | 14.1 | 20.2 |
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| EC50 (µg/ml). Effective concentration at 50% cytotoxicity. (using a specific sigmoidal equation = model). |
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| 123 |
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| Rows 1-2: | Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study. | | Row 3: | Shows that this study was conducted as a GLP study. | | Rows 4-5: | Show the study start date and study title. | | Rows 6-7: | Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study. | | Row 8: | Shows the applicant's organization. | | Row 9: | Shows that the applicant's study reference ID is not applicable. | | Rows 10-13: | Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The study director is associated with the test facility. | | Rows 14-16: | Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER). | | Shows the study type for this study. | | Shows that this study includes a Neutral Red Uptake Assay. | | Rows 19-20: | Show that the species is human and the cell line is NHK in this study. |
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| title | ts.xpt (trial summary, study level parameters) |
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- Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
- Assumption: A Trial (study) can have more than one assay type
- Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
- BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
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Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 123 | ALL | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | 2 | 123 | ALL | TS | 2 | GLPTYP | Good Laboratory Practice Type | OECD | 3 | 123 | ALL | TS | 1 | STSTDTC | Study Start Date | 2022-05-25 | 4 | 123 | ALL | TS | 1 | | Dataset2 |
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| Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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| 1 | 123 | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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| GLPTYP | Good Laboratory Practice Type | OECD |
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| GLPFL | GLP Flag | Y |
| | 4 | 123 | TS | 1 |
| STSTDTC | Study Start Date | 2022-05-25 |
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| STITLE | Study Title | Determination of the in vitro genotoxicity potential |
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of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro using the in vitro Neutral Red Uptake assay |
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5ALL | | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
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6ALL | | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
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7ALL | SSPONSORSponsor Organization Sponsor 8ALL | SPREFIDSponsor's | Applicant Study Reference ID |
| NOT APPLICABLE |
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9ALL | | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example |
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Tox 10ALL | | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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11ALL | | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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...ALL | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
| | 14 | 123 |
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ALL | 4 | TSTGDNAM | Testing Guideline Name | Publication No. 07-4519 |
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GLPFL | GLP Flag | YMNvit | ASTDAssay Standard | OECD Test No. 487 | | TSTGDORG | Testing Guideline Organization | NIH |
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123 | MNvitASTDV | | 4 | TSTGDVER | Testing Guideline |
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Assay Standard 2016-07-29MNvit | | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
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MNvitSSSTYP | Study Sub Type | In Vitro Micronucleus |
| GNTXAID | Genetic Toxicology Assay Identifier | NRU |
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123 | MNvitHomo SapiensMNvit | ?? | Test System? | TK6 Lymphoblastoid Suspension Cells | 123 | NRU | TS | 1 | ASTD | Assay Standard | NIH Publication No. 07-4519 | 123 | NRU | TS | 1 | ASTDV | Assay Standard Version | 2006-11 | 123 | NRU | TS | 1 | SSTYP | Study Type | GENOTOXICITY IN VITRO | 123 | NRU | TS | 1 | SSSTYP | Study Sub Type | In Vitro Neutral Red Uptake | 123 | NRU | TS | 1 | SPECIES | Species | Salmonella enterica | 123 | NRU | TS | 1 | ?? | Test System?? | Normal Human Keratinocyte | | Expand |
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- During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
- Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
- BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
- Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level
| Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | NRU | TX | 1-1-A(plate-col-row in the 96-well plate) | CSC-10(through SLS-200) | PLATENUM. (e.g., 1 or 2) | 1 | 1 | 2 | 123 | NRU | TX | 1-1-A | CSC-10 | WELLNUM (e.g., 1-A through 10-H) | Number representing the location of the well in the 96-well plate | 1-A | 3 | 123 | NRU | TX | 1-1-A | CSC-10 | INTRVN | name of the intervention article | Cigarette Smoke Condensate | 4 | 123 | NRU | TX | 1-1-A | CSC-10 | ITVTYPE(CT e.g, Product, positive control, negative control) | type of intervention article | PRODUCT | 5 | 123 | NRU | TX | 1-1-A | CSC-10 | ITVCONC | intervention concentration | 10 | 6 | 123 | NRU | TX | 1-1-A | CSC-10 | ITVCONCU | intervention unit | ug/ml | 123 | NRU | 1 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 123 | NRU | 1 | REGIME | Smoking Regime | Traditional combustible | 123 | NRU | 1 | RUN | Assay run number (how is this different from REPNUM) | 1 | 123 | NRU | 1 | PORT | Port ID | 1 | 123 | NRU | 1 | SMPLID | Sample ID | 030001 | 123 | NRU | 1 | SMKFRC | Smoke Fraction | A | 123 | NRU | 1 | REPNUM | Replicate Number | 1 | 11 | 123 | NRU | TX | 1-1-B | CSC-10 | ITVCONC | intervention concentration | 10 | 12 | 123 | NRU | TX | 1-1-B | CSC-10 | ITVCONCU | intervention unit | ug/ml | ... | ... | 123 | NRU | TX | 1-10-H | SLS-10 | PLATENUM | Plate number | 1 | 123 | NRU | TX | 1-10-H | SLS-10 | WELLNUM | Number representing the location of the well in the 96-well plate | 10-H | 123 | NRU | TX | 1-10-H | SLS-10 | INTRVN | name of the intervention article | sodium laurel sulfate | 123 | NRU | TX | 1-10-H | SLS-10 | ITVTYPE | type of intervention article | POSITIVE CONTROL | 123 | NRU | TX | 1-10-H | SLS-10 | ITVCONC | intervention concentration | 200 | 123 | NRU | TX | 1-10-H | SLS-10 | ITVCONCU | intervention unit | ug/ml | ... | ... | 123 | NRU | TX | 2-10-H | SLS-10 | PLATENUM | Plate number | 2 | 123 | NRU | TX | 2-10-H | SLS-10 | WELLNUM | Number representing the location of the well in the 96-well plate | 10-H | 123 | NRU | TX | 2-10-H | SLS-10 | INTRVN | name of the intervention article | sodium laurel sulfate | 123 | NRU | TX | 2-10-H | SLS-10 | ITVTYPE | type of intervention article | POSITIVE CONTROL | 123 | NRU | TX | 2-10-H | SLS-10 | ITVCONC | intervention concentration | 200 | 123 | NRU | TX | 2-10-H | SLS-10 | ITVCONCU | intervention unit | ug/ml | 123 | MNvit | TX | A1 | METACT | Metabolic Activation (should there be two parms? Presence, type)? | +S9 | 123 | MNvit | TX | A1 | TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) | 3 | |
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| Rows 1-12: | Show the test conditions for the set with a short name or SETCD value of NRU. The applicant chose this value to represent test conditions for the entire assay. | | Rows 13-31: | Show the test conditions for the set with a short name or SETCD value of CSC-50b. The applicant chose this value to represent plate number 1, well row A, well column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123. The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells. | Rows 32-50: | Show the test conditions for the set with a short name or SETCD value of CSC-50. The applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2, well rows A-H, well column 3. These all have the concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123. | | Rows 51-69: | Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent plate number 1, well rows B-G, well column 10, and plate number 2, well rows A-H, well column 10. These all have the concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123. |
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| ROW | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 123 | TX | NRU | NRU_ASSAY | 1 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 2 | 123 | TX | NRU | NRU_ASSAY | 2 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 3 | 123 | TX | NRU | NRU_ASSAY | 3 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 4 | 123 | TX | NRU | NRU_ASSAY | 4 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 5 | 123 | TX | NRU | NRU_ASSAY | 5 | INCBTMP | Incubation Temperature | 37 | | 6 | 123 | TX | NRU | NRU_ASSAY | 6 | INCBTMPU | Incubation Temperature Unit | C | | 7 | 123 | TX | NRU | NRU_ASSAY | 7 | SWAVENM | Spectrophotometer Wavelength | 540 | | 8 | 123 | TX | NRU | NRU_ASSAY | 8 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 9 | 123 | TX | NRU | NRU_ASSAY | 9 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 10 | 123 | TX | NRU | NRU_ASSAY | 10 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 11 | 123 | TX | NRU | NRU_ASSAY | 11 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 12 | 123 | TX | NRU | NRU_ASSAY | 12 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 13 | 123 | TX | CSC-50b | CSC-50-blank | 13 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 14 | 123 | TX | CSC-50b | CSC-50-blank | 14 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 15 | 123 | TX | CSC-50b | CSC-50-blank | 15 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 16 | 123 | TX | CSC-50b | CSC-50-blank | 16 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 17 | 123 | TX | CSC-50b | CSC-50-blank | 17 | INCBTMP | Incubation Temperature | 37 | | 18 | 123 | TX | CSC-50b | CSC-50-blank | 18 | INCBTMPU | Incubation Temperature Unit | C | | 19 | 123 | TX | CSC-50b | CSC-50-blank | 19 | SWAVENM | Spectrophotometer Wavelength | 540 | | 20 | 123 | TX | CSC-50b | CSC-50-blank | 20 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 21 | 123 | TX | CSC-50b | CSC-50-blank | 21 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 22 | 123 | TX | CSC-50b | CSC-50-blank | 22 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 23 | 123 | TX | CSC-50b | CSC-50-blank | 23 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 24 | 123 | TX | CSC-50b | CSC-50-blank | 24 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 25 | 123 | TX | CSC-50b | CSC-50-blank | 25 | EXPTYP | Exposure Type | Air Liquid Interface | | 26 | 123 | TX | CSC-50b | CSC-50-blank | 26 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | | 27 | 123 | TX | CSC-50b | CSC-50-blank | 27 | ITVNAM | Name of the Intervention Article | Tobacco ProdA | | 28 | 123 | TX | CSC-50b | CSC-50-blank | 28 | ITVTYPE | Intervention Article Type | PRODUCT | | 29 | 123 | TX | CSC-50b | CSC-50-blank | 29 | ITVCONC | Intervention Article Concentration | 50 | | 30 | 123 | TX | CSC-50b | CSC-50-blank | 30 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | | 31 | 123 | TX | CSC-50b | CSC-50-blank | 31 | CELLLN | Cell Line | NOT APPLICABLE | | 32 | 123 | TX | CSC-50 | CSC-50 | 32 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 33 | 123 | TX | CSC-50 | CSC-50 | 33 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 34 | 123 | TX | CSC-50 | CSC-50 | 34 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 35 | 123 | TX | CSC-50 | CSC-50 | 35 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 36 | 123 | TX | CSC-50 | CSC-50 | 36 | INCBTMP | Incubation Temperature | 37 | | 37 | 123 | TX | CSC-50 | CSC-50 | 37 | INCBTMPU | Incubation Temperature Unit | C | | 38 | 123 | TX | CSC-50 | CSC-50 | 38 | SWAVENM | Spectrophotometer Wavelength | 540 | | 39 | 123 | TX | CSC-50 | CSC-50 | 39 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 40 | 123 | TX | CSC-50 | CSC-50 | 40 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 41 | 123 | TX | CSC-50 | CSC-50 | 41 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 42 | 123 | TX | CSC-50 | CSC-50 | 42 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 43 | 123 | TX | CSC-50 | CSC-50 | 43 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 44 | 123 | TX | CSC-50 | CSC-50 | 44 | EXPTYP | Exposure Type | Air Liquid Interface | | 45 | 123 | TX | CSC-50 | CSC-50 | 45 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | | 46 | 123 | TX | CSC-50 | CSC-50 | 46 | ITVNAM | Intervention Article Name | Tobacco ProdA | | 47 | 123 | TX | CSC-50 | CSC-50 | 47 | ITVTYPE | Intervention Article Type | PRODUCT | | 48 | 123 | TX | CSC-50 | CSC-50 | 48 | ITVCONC | Intervention Article Concentration | 50 | | 49 | 123 | TX | CSC-50 | CSC-50 | 49 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | | 50 | 123 | TX | CSC-50 | CSC-50 | 50 | CELLLN | Cell Line | NHK | | 51 | 123 | TX | SLS-110 | SLS-110 | 51 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 52 | 123 | TX | SLS-110 | SLS-110 | 52 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 53 | 123 | TX | SLS-110 | SLS-110 | 53 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 54 | 123 | TX | SLS-110 | SLS-110 | 54 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 55 | 123 | TX | SLS-110 | SLS-110 | 55 | INCBTMP | Incubation Temperature | 37 | | 56 | 123 | TX | SLS-110 | SLS-110 | 56 | INCBTMPU | Incubation Temperature Unit | C | | 57 | 123 | TX | SLS-110 | SLS-110 | 57 | SWAVENM | Spectrophotometer Wavelength | 540 | | 58 | 123 | TX | SLS-110 | SLS-110 | 58 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 59 | 123 | TX | SLS-110 | SLS-110 | 59 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 60 | 123 | TX | SLS-110 | SLS-110 | 60 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 61 | 123 | TX | SLS-110 | SLS-110 | 61 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 62 | 123 | TX | SLS-110 | SLS-110 | 62 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 63 | 123 | TX | SLS-110 | SLS-110 | 63 | EXPTYP | Exposure Type | Air Liquid Interface | | 64 | 123 | TX | SLS-110 | SLS-110 | 64 | SAMTYP | Sample Type | Liquid | | 65 | 123 | TX | SLS-110 | SLS-110 | 65 | ITVNAM | Intervention Article Name | Sodium Laurel Sulfate | | 66 | 123 | TX | SLS-110 | SLS-110 | 66 | ITVTYPE | Intervention Article Type | POSITIVE CONTROL | | 67 | 123 | TX | SLS-110 | SLS-110 | 67 | ITVCONC | Intervention Article Concentration | | | 68 | 123 | TX | SLS-110 | SLS-110 | 68 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | | 69 | 123 | TX | SLS-110 | SLS-110 | 69 | CELLLN | Cell Line | NHK |
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The applicant chose to define the REFID values to indicate the Plate, the Column, and the Row of the wells of the 96-well plate in use, such that the well on plate 2, column 10, row G would assigned a REFID of 2-10-G. | Rowcaps |
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| Row 1: | Shows the REFID of 123NRU that indicates the entire assay. | | Rows 2-4: | Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3, 1-10, 2-10) which have LVLDESC of OBSERVATIONAL SUMMARY. If this study had recorded summary statistics for an entire trial set (e.g., across both plates for the same dose level), there would be an additional REFID for the trial set (with a LVLDESC of TRIAL SET). | | Rows 5-6: | Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units that are also observational units within the SETCD of CSC-50b that have the parent REFID of 123NRU. | | Rows 7-8: | Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units that are also observational units within the SETCD of CSC-50 that have the parent REFID of 1-3. | | Row 9: | Shows the REFID of 1-10-G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 1-10. | | Row 10: | Shows the REFID of 2-10-G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 2-10. |
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| | Row | STUDYID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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| 1 | 123 | | 123NRU |
| 1 | ASSAY | | 2 | 123 | CSC-50 | 1-3 | 123NRU | 2 | OBSERVATIONAL SUMMARY | | 3 | 123 | SLS-110 | 1-10 | 123NRU | 2 | OBSERVATIONAL SUMMARY | | 4 | 123 | SLS-110 | 2-10 | 123NRU | 2 | OBSERVATIONAL SUMMARY | | 5 | 123 | CSC-50b | 1-3-A | 123NRU | 2 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 6 | 123 | CSC-50b | 1-3-H | 123NRU | 2 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 7 | 123 | CSC-50 | 1-3-B | 1-3 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 8 | 123 | CSC-50 | 1-3-C | 1-3 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 9 | 123 | SLS-110 | 1-10-G | 1-10 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 10 | 123 | SLS-110 | 2-10-G | 2-10 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT |
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Certain data (Absorbance Reading and Background Corrected Absorbance Reading) are not shown in the sample report table above but are included here for completeness of the NRU assay. | Rowcaps |
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| Rows 1-3: | Show the experimental unit data for GTREFID 1-3-B. | | Rows 4-6: | Show the experimental unit data for GTREFID 1-3-C. | | Rows 7-9: | Show the data for the entire trial set, GTREFID=1-3. | | Rows 10-12: | Show the experimental unit data for GTREFID 1-10-G | | Rows 13-15: | Show the data for the entire trial set, GTREFID=1-10 | | Rows 16-18: | Show the experimental unit data for GTREFID 2-10-G. | | Rows 19-21: | Show the data for the entire trial set, GTREFID=2-10 | | Row 22: | Shows the data for the entire assay, GTREFID=123NRU. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | GTSEQ | GTREFID | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTCOLSRT | GTSTRESC | GTSTRESN | GTSTRESU |
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| 1 | 123 | GT | 1 | 1-3-B | ABSORB | Absorbance Reading | 1.7 |
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| 1.7 | 1.7 |
| | 2 | 123 | GT | 2 | 1-3-B | BKCABS | Background Corrected Absorbance Reading | 1.6 |
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| 1.6 | 1.6 |
| | 3 | 123 | GT | 3 | 1-3-B | RELABS | Relative Absorbance Reading | 77.7 |
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| 77.7 | 77.7 |
| | 4 | 123 | GT | 4 | 1-3-C | ABSORB | Absorbance Reading | 1.8 |
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| 1.8 | 1.8 |
| | 5 | 123 | GT | 5 | 1-3-C | BKCABS | Background Corrected Absorbance Reading | 1.7 |
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| 1.7 | 1.7 |
| | 6 | 123 | GT | 6 | 1-3-C | RELABS | Relative Absorbance Reading | 77.4 |
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| 77.4 | 77.4 |
| | 7 | 123 | GT | 7 | 1-3 | RELABS | Relative Absorbance Reading | 78.2 | % | MEAN | 78.2 | 78.2 | % | | 8 | 123 | GT | 8 | 1-3 | RELABS | Relative Absorbance Reading | 2.9 | % | STANDARD DEVIATION | 2.9 | 2.9 | % | | 9 | 123 | GT | 9 | 1-3 | RELABS | Relative Absorbance Reading | 3.6 |
| COEFFICIENT OF VARIANCE | 3.6 | 3.6 |
| | 10 | 123 | GT | 10 | 1-10-G | ABSORB | Absorbance Reading | 0.7 |
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| 0.7 | 0.7 |
| | 123 | GT | 11 | 1-10-G | BKCABS | Background Corrected Absorbance Reading | 0.6 |
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| 0.6 | 0.6 |
| | 12 | 123 | GT | 12 | 1-10-G | RELABS | Relative Absorbance Reading | 8.57 |
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| 8.57 | 8.57 |
| | 13 | 123 | GT | 13 | 1-10 | RELABS | Relative Absorbance Reading | 8.94 | % | MEAN | 8.94 | 8.94 |
| | 14 | 123 | GT | 14 | 1-10 | RELABS | Relative Absorbance Reading | 2.72 | % | STANDARD DEVIATION | 2.72 | 2.72 |
| | 15 | 123 | GT | 15 | 1-10 | RELABS | Relative Absorbance Reading | 30.5 |
| COEFFICIENT OF VARIANCE | 30.5 | 30.5 |
| | 16 | 123 | GT | 16 | 2-10-G | ABSORB | Absorbance Reading | 0.9 |
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| | 17 | 123 | GT | 17 | 2-10-G | BKCABS | Background Corrected Absorbance Reading | 0.8 |
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| | 18 | 123 | GT | 18 | 2-10-G | RELABS | Relative Absorbance Reading | 6.30 |
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| 6.30 | 6.30 |
| | 19 | 123 | GT | 19 | 2-10 | RELABS | Relative Absorbance Reading | 5.91 | % | MEAN | 5.91 | 5.91 |
| | 20 | 123 | GT | 20 | 2-10 | RELABS | Relative Absorbance Reading | 0.83 | % | STANDARD DEVIATION | 0.83 | 0.83 |
| | 21 | 123 | GT | 21 | 2-10 | RELABS | Relative Absorbance Reading | 14.1 |
| COEFFICIENT OF VARIANCE | 14.1 | 14.1 |
| | 22 | 123 | GT | 22 | 123NRU | | Effective Concentration of 50 Percent Cytotoxicity | 123 | ug/ml |
| 123 | 123 | ug/ml |
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123 | MNvit | TX | 123 | MNvit | TX | TRTDRTOL | Treatment Duration Tolerance | 123 | MNvit | TX | TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | H | 123 | MNvit | TX | INTRVN | name of the intervention article | Bleomycin or Cyclophosphamid A | 123 | MNvit | TX | ITVTYPE | type of intervention article | choices of values: product; negative control; positive control | 123 | MNvit | TX | A1 | ITVCONC | Concentration of i a | 0 | 123 | MNvit | TX | A1 | ITVCONCU | Concentration Unit | ug/ml | | Expand |
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| title | gt.xpt (similar to LB) |
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| Row | STUDYID | ASSAYID | DOMAIN | TXCD | GTSEQ | GTTESTCD | GTTEST | GTCELLEV
(cells evaluated) | GTORRES | GTORRESU | GTSTRESC | GTSTRESN | GTSTRESU | GTDTC | GTNOMDY | GTELTM | GTTPTREF |
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1 | 123 | NRU | GT | 1-1-A | 1 | RELABS | Relative Absorbance Reading | 100 | ug/ml | 100 | 100 | ug/ml | 2 | 123 | NRU | GT | 1-1-B | 1 | RELABS | Relative Absorbance Reading | 107 | ug/ml | 100 | 100 | ug/ml | 3 | 123 | NRU | GT | 1-1-C | 1 | RELABS | Relative Absorbance Reading | 98.6 | ug/ml | 100 | 100 | ug/ml | 54 | 123 | NRU | GT | 1-1-D | 1 | RELABS | Relative Absorbance Reading | 94.9 | ug/ml | 100 | 100 | ug/ml | 6 | 123 | NRU | GT | 1-1-E | 1 | RELABS | Relative Absorbance Reading | 111 | 7 | 123 | NRU | GT | 1-1-F | 1 | RELABS | Relative Absorbance Reading | 96.9 | 8 | 123 | NRU | GT | 1-1-G | 1 | RELABS | Relative Absorbance Reading | 105 | 9 | 123 | NRU | GT | 1-1-H | 1 | RELABS | Relative Absorbance Reading | 95.2 | 10 | 123 | NRU | GT | 1-2-A | 1 | RELABS | Relative Absorbance Reading | 83.0 | 11 | 123 | NRU | GT | 1-2-B | 1 | RELABS | Relative Absorbance Reading | 77.7 | ... | ... | 80 | 123 | NRU | GT | 1-10-H | 1 | RELABS | Relative Absorbance Reading | 0.791 | ... | ... | 160 | 123 | NRU | GT | 2-10-H | 1 | RELABS | Relative Absorbance Reading | 0.780 | 1 | 123 | MNvit | GT | A2 | 1 | RICC | Relative Increase in Cell Count | 134 | 15.7 | % | 15.7 | 15.7 | % | 2022-05-25 | 2 | 123 | MNvit | GT | A2 | 2 | RCC | Relative Cell Count | 134 | 13.0 | % | 13.0 | 13.0 | % | 2022-05-25 | 3 | 123 | MNvit | GT | A2 | 3 | RPD | Relative Population Doubling | 134 | 7.9 | % | 7.9 | 7.9 | % | 2022-05-25 | 4 | 123 | MNvit | GT | A2 | 4 | MNCELLS | Micronucleated Cells | 3266 | 20 | Cells | 20 | 20 | Cells | 2022-05-25 | 5 | 123 | MNvit | GT | A2 | 5 | MNCELLS | Micronucleated Cells | 2190 | 17 | Cells | 17 | 17 | Cells | 2022-05-25 | 6 | 123 | MNvit | GT | A2 | 6 | MNCELLS | Micronucleated Cells | 2758 | 13 | Cells | 13 | 13 | Cells | 2022-05-25 | 7 | 123 | MNvit | GT | A2 | 7 | MNCELLS | Micronucleated Cells | 2714 | 21 | Cells | 21 | 21 | Cells | 2022-05-25 | 8 | 123 | MNvit | GT | A2 | 8 | AVGREL | Average Relative MN Frequency | 0.66 | % | 0.66 | 0.66 | % | 2022-05-25 | 9 | 123 | MNvit | GT | A1 | 1 | RICC | Relative Increase in Cell Count | 154 | 0 | % | 0 | 0 | % | 2022-05-25 | 10 | 123 | MNvit | GT | A1 | 2 | RCC | Relative Cell Count | 154 | 0 | % | 0 | 0 | % | 2022-05-25 | 11 | 123 | MNvit | GT | A1 | 3 | RPD | Relative Population Doubling | 154 | 0 | % | 0 | 0 | % | 2022-05-25 | 12 | 123 | MNvit | GT | A1 | 4 | MNCELLS | Micronucleated Cells | 3266 | 15 | Cells | 15 | 15 | Cells | 2022-05-25 | 13 | 123 | MNvit | GT | A1 | 5 | MNCELLS | Micronucleated Cells | 2190 | 13 | Cells | 13 | 13 | Cells | 2022-05-25 | 14 | 123 | MNvit | GT | A1 | 6 | MNCELLS | Micronucleated Cells | 2758 | 17 | Cells | 17 | 17 | Cells | 2022-05-25 | 15 | 123 | MNvit | GT | A1 | 7 | MNCELLS | Micronucleated Cells | 2714 | 12 | Cells | 12 | 12 | Cells | 2022-05-25 | 16 | 123 | MNvit | GT | A1 | 8 | AVGREL | Average Relative MN Frequency | 0.57 | % | 0.57 | 0.57 | % | 2022-05-25