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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
du.xpt (device in-use properties)
We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine, but is currently not shown for brevity.
Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input). Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic) The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K" Do we need both SPDEVID AND DUREFID? du.xpt
STUDYID
DOMAIN
SPDEVID
DUSEQ
DUREFID
DUGRPID
DUTESTCD
DUTEST
DUORRES
DUORRESU
DUSTRESC
DUSTRESN
DUSTRESU
1 123 DU PUFFMASTER3K 1 Medium Intensity Regimen PUFFPROF Puff Profile SQUARE SQUARE 2 123 DU PUFFMASTER3K 2 Medium Intensity Regimen PUFFDUR
Puff Duration 1.25
sec
1.25
1.25 sec
3 123 DU PUFFMASTER3K 3 Medium Intensity Regimen PUFFINT
Puff Interval 3
PUFF/min
3
3 PUFF/min
4 123 DU PUFFMASTER3K 4 Medium Intensity Regimen PUFFBLCK
Puff Block 25
%
25
25 %
5 123 DU PUFFMASTER3K 5 Medium Intensity Regimen NUMPUFF Total Number of Puffs 200
PUFF
200
200 PUFF
6 123 DU PUFFMASTER3K 6 Medium Intensity Regimen PUFFVOL Puff Volume 10
mL
10
10 mL
7 123 DU PUFFMASTER3K 7 Medium Intensity Regimen PUFFRNG Puff Range 100-200
100-200
8 123 DU PUFFMASTER3K 8 Medium Intensity Regimen 1 PUFFPAUS Puff Pause 60
s
60
60 s
9 123 DU PUFFMASTER3K 9 Medium Intensity Regimen 1 PUFFPINT Puff Pause Interval 10
PUFF
10
10 PUFF
10 123 DU PUFFMASTER2023 1 Canadian Intense Regime
PUFFPROF Puff Profile SQUARE SQUARE 11 123 DU PUFFMASTER2023 2 Canadian Intense Regime PUFFDUR
Puff Duration 2.00
sec
2.00
2.00 sec
12 123 DU PUFFMASTER2023 3 Canadian Intense Regime PUFFINT
Puff Interval 4
PUFF/min
4
4 PUFF/min
13 123 DU PUFFMASTER2023 4 Canadian Intense Regime
PUFFBLCK
Puff Block 0
%
0
0 %
14 123 DU PUFFMASTER2023 5 Canadian Intense Regime NUMPUFF Total Number of Puffs 200
PUFF
200
200 PUFF
15 123 DU PUFFMASTER2023 6 Canadian Intense Regime PUFFVOL Puff Volume 10
mL
10
10 mL
16 123 DU PUFFMASTER2023 7 Canadian Intense Regime
PUFFRNG Puff Range 100-200
100-200
17 123 DU PUFFMASTER2023 8 Canadian Intense Regime 1 PUFFPAUS Puff Pause 60
s
60
60 s
18 123 DU PUFFMASTER2023 9 Canadian Intense Regime 1 PUFFPINT Puff Pause Interval 10
PUFF
10
10 PUFF
gt.xpt (similar to LB)
A1:
A2:
Row STUDYID ASSAYID DOMAIN TXSETCD GTSEQ GTTESTCD GTTEST GTCELLEV(cells evaluated) GTORRES GTORRESU GTSTRESC GTSTRESN GTSTRESU GTDTC 1 123 MNvit GT A1 1 RICC Relative Increase in Cell Count 0 0 % 0 0 % 2022-05-25 2 123 MNvit GT A1 2 RCC Relative Cell Count 154 0 % 0 0 % 2022-05-25 3 123 MNvit GT A1 3 RPD Relative Population Doubling 154 0 % 0 0 % 2022-05-25 4 123 MNvit GT A1 4 MNCELLS Micronucleated Cells 2205 15 Cells 15 15 Cells 2022-05-25 5 123 MNvit GT A1 5 MNCELLS Micronucleated Cells 2474 13 Cells 13 13 Cells 2022-05-25 6 123 MNvit GT A1 6 MNCELLS Micronucleated Cells 2758 17 Cells 17 17 Cells 2022-05-25 7 123 MNvit GT A1 7 MNCELLS Micronucleated Cells 2669 12 Cells 12 12 Cells 2022-05-25 8 123 MNvit GT A1 8 AVGREL Average Relative MN Frequency 0.57 % 0.57 0.57 % 2022-05-25 9 123 MNvit GT A2 1 RICC Relative Increase in Cell Count 134 15.7 % 15.7 15.7 % 2022-05-25 10 123 MNvit GT A2 2 RCC Relative Cell Count 134 13.0 % 13.0 13.0 % 2022-05-25 11 123 MNvit GT A2 3 RPD Relative Population Doubling 134 7.9 % 7.9 7.9 % 2022-05-25 12 123 MNvit GT A2 4 MNCELLS Micronucleated Cells 3266 20 Cells 20 20 Cells 2022-05-25 13 123 MNvit GT A2 5 MNCELLS Micronucleated Cells 2190 17 Cells 17 17 Cells 2022-05-25 14 123 MNvit GT A2 6 MNCELLS Micronucleated Cells 2758 13 Cells 13 13 Cells 2022-05-25 15 123 MNvit GT A2 7 MNCELLS Micronucleated Cells 2714 21 Cells 21 21 Cells 2022-05-25 16 123 MNvit GT A2 8 AVGREL Average Relative MN Frequency 0.66 % 0.66 0.66 % 2022-05-25 ...
