Comment:
Corrected the value of ITVCONC (row 40 in TX dataset) and renumbered SEQ in GT dataset
...
Dataset wrap
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-279
Rowcaps
Rows 1-12:
Show the test conditions for the set with a short name or SETCD value of ALL. The applicant chose this value to represent test conditions for the entire assay.
Rows 13-20:
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 number 1, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.
Row 20:
Shows the value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.
Rows 21-28:
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 number 2, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.
Rows 29-36:
Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent both wells numbered 7 in plate number 1 and 2, with a concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123.
Dataset2
Row
STUDYID
GNTXAID
DOMAIN
SETCD
SET
TXSEQ
TXPARMCD
TXPARM
TXVAL
1
123
NRU
TX
ALL
ALL_ASSAY
1
TRTDMIN
In vitro Treatment Duration Minimum
47.5
2
123
NRU
TX
ALL
ALL_ASSAY
2
TRTDTRG
In vitro Treatment Duration Target
48
3
123
NRU
TX
ALL
ALL_ASSAY
3
TRTDMAX
In vitro Treatment Duration Maximum
48.5
4
123
NRU
TX
ALL
ALL_ASSAY
4
TRTDU
In vitro Treatment Duration Unit
HOURS
5
123
NRU
TX
ALL
ALL_ASSAY
5
INCBTMP
Incubation Temperature
37
6
123
NRU
TX
ALL
ALL_ASSAY
6
INCBTMPU
Incubation Temperature Unit
C
7
123
NRU
TX
ALL
ALL_ASSAY
7
WAVELGTH
Spectrophotometer wavelength in nanometers
540
8
123
NRU
TX
ALL
ALL_ASSAY
8
HUMID
Atmospheric Relative Humidity Percent
90
9
123
NRU
TX
ALL
ALL_ASSAY
9
ATMCO2
Atmospheric CO2 Percent
5
10
123
NRU
TX
ALL
ALL_ASSAY
10
SPDEVID
applicant defined device identifier
PUFFMASTER3k
11
123
NRU
TX
ALL
ALL_ASSAY
11
DUREFID
Smoking Regime
Medium Intensity Regimen
12
123
NRU
TX
ALL
ALL_ASSAY
12
SPTOBID
Applicant-defined tobacco identifier
CIG01a
13
123
NRU
TX
CSC-50b
CSC-50-blank
13
PSETCD
Parent Set Code
ALL
14
123
NRU
TX
CSC-50b
CSC-50-blank
14
EXPTYP
Exposure Type
Air Liquid Interface
15
123
NRU
TX
CSC-50b
CSC-50-blank
15
SAMTYP
Sample Type
Whole Smoke Conditioned Media
16
123
NRU
TX
CSC-50b
CSC-50-blank
16
INTRVN
Name of the Intervention Article
Tobacco ProdA
17
123
NRU
TX
CSC-50b
CSC-50-blank
17
ITVTYPE
Type of intervention article
PRODUCT
18
123
NRU
TX
CSC-50b
CSC-50-blank
18
ITVCONC
Concentration of intervention article
50
19
123
NRU
TX
CSC-50b
CSC-50-blank
19
ITVCONCU
Concentration Unit
ug/ml
20
123
NRU
TX
CSC-50b
CSC-50-blank
20
CELLLN
Cell Line
NOT APPLICABLE
21
123
NRU
TX
CSC-50
CSC-50
21
PSETCD
Parent Set Code
ALL
22
123
NRU
TX
CSC-50
CSC-50
22
EXPTYP
Exposure Type
Air Liquid Interface
23
123
NRU
TX
CSC-50
CSC-50
23
SAMTYP
Sample Type
Whole Smoke Conditioned Media
24
123
NRU
TX
CSC-50
CSC-50
24
INTRVN
Name of the Intervention Article
Tobacco ProdA
25
123
NRU
TX
CSC-50
CSC-50
25
ITVTYPE
Type of intervention article
PRODUCT
26
123
NRU
TX
CSC-50
CSC-50
26
ITVCONC
Concentration of intervention article
50
27
123
NRU
TX
CSC-50
CSC-50
27
ITVCONCU
Concentration Unit
ug/ml
28
123
NRU
TX
CSC-50
CSC-50
28
CELLLN
Cell Line
NHK
29
123
NRU
TX
SLS-110
SLS-110
29
PSETCD
Parent Set Code
ALL
30
123
NRU
TX
SLS-110
SLS-110
30
EXPTYP
Exposure Type
Air Liquid Interface
31
123
NRU
TX
SLS-110
SLS-110
31
SAMTYP
Sample Type
Liquid
32
123
NRU
TX
SLS-110
SLS-110
32
INTRVN
Name of the Intervention Article
Sodium Laurel Sulfate
33
123
NRU
TX
SLS-110
SLS-110
33
ITVTYPE
Type of intervention article
POSITIVE CONTROL
34
123
NRU
TX
SLS-110
SLS-110
34
ITVCONC
Concentration of intervention article
200110
35
123
NRU
TX
SLS-110
SLS-110
35
ITVCONCU
Concentration Unit
ug/ml
36
123
NRU
TX
SLS-110
SLS-110
36
CELLLN
Cell Line
NHK
...
Dataset wrap
Name
gt
Rowcaps
Rows 1-3:
Show the experimental unit data for GTREFID 1-3-B.
Rows 1-2, 4-5, 10-11, 16-17:
These data (absorbance reading and background absorbance reading) are not shown in the sample report table above but included here for completeness of the NRU assay.
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.
Dataset2
Row
STUDYID
GNTXAID
DOMAIN
GTSEQ
GTREFID
GTTESTCD
GTTEST
GTORRES
GTORRESU
GTCOLSRT
GTSTRESC
GTSTRESN
GTSTRESU
1
123
NRU
GT
1
1-3-B
ABSORB
Absorbance Reading
1.7
1.7
1.7
2
123
NRU
GT
2
1-3-B
BKCABS
Background Corrected Absorbance Reading
1.6
1.6
1.6
3
123
NRU
GT
3
1-3-B
RELABS
Relative Absorbance Reading
77.7
%
77.7
77.7
%
4
123
NRU
GT
4
1-3-C
ABSORB
Absorbance Reading
1.8
1.8
1.8
5
123
NRU
GT
5
1-3-C
BKCABS
Background Corrected Absorbance Reading
1.7
1.7
1.7
6
123
NRU
GT
6
1-3-C
RELABS
Relative Absorbance Reading
77.4
77.4
77.4
7
123
NRU
GT
7
1-3
RELABS
Relative Absorbance Reading
78.2
%
MEAN
78.2
78.2
%
8
123
NRU
GT
8
1-3
RELABS
Relative Absorbance Reading
2.9
%
STANDARD DEVIATION
2.9
2.9
%
9
123
NRU
GT
9
1-3
RELABS
Relative Absorbance Reading
3.6
COEFFICIENT OF VARIANCE
3.6
3.6
10
123
NRU
GT
10
1-10-G
ABSORB
Absorbance Reading
0.7
0.7
0.7
11
123
NRU
GT
11
1-10-G
BKCABS
Background Corrected Absorbance Reading
0.6
0.6
0.6
12
123
NRU
GT
1112
1-10-G
RELABS
Relative Absorbance Reading
8.57
8.57
8.57
13
123
NRU
GT
1213
1-10
RELABS
Relative Absorbance Reading
8.94
%
MEAN
8.94
8.94
14
123
NRU
GT
1314
1-10
RELABS
Relative Absorbance Reading
2.72
%
STANDARD DEVIATION
2.72
2.72
15
123
NRU
GT
1415
1-10
RELABS
Relative Absorbance Reading
30.5
COEFFICIENT OF VARIANCE
30.5
30.5
16
123
NRU
GT
1516
2-10-G
ABSORB
Absorbance Reading
0.9
17
123
NRU
GT
1617
2-10-G
BKCABS
Background Corrected Absorbance Reading
0.8
18
123
NRU
GT
1718
2-10-G
RELABS
Relative Absorbance Reading
6.30
6.30
6.30
19
123
NRU
GT
1819
2-10
RELABS
Relative Absorbance Reading
5.91
%
MEAN
5.91
5.91
20
123
NRU
GT
1920
2-10
RELABS
Relative Absorbance Reading
0.83
%
STANDARD DEVIATION
0.83
0.83
21
123
NRU
GT
2021
2-10
RELABS
Relative Absorbance Reading
14.1
COEFFICIENT OF VARIANCE
14.1
14.1
22
123
NRU
GT
2122
123NRU
EC50CYTX
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-132
Effective Concentration of 50 Percent Cytotoxicity