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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


 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

Row

STUDYID

DOMAIN

SPDEVID

DUSEQ

DUREFID

DUGRPID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

1123DUPUFFMASTER3K1Medium Intensity Regimen
PUFFPROFPuff ProfileSQUARE
SQUARE

2123DUPUFFMASTER3K2Medium Intensity Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3123DUPUFFMASTER3K3Medium Intensity Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4123DUPUFFMASTER3K4Medium Intensity Regimen

PUFFBLCK

Puff Block

25

%

25

25

%

5123DUPUFFMASTER3K5Medium Intensity Regimen
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

6123DUPUFFMASTER3K6Medium Intensity Regimen
PUFFVOLPuff Volume

10

mL

10

10

mL

7123DUPUFFMASTER3K7Medium Intensity Regimen
PUFFRNGPuff Range

100-200


100-200



8123DUPUFFMASTER3K8Medium Intensity Regimen1PUFFPAUSPuff Pause

60

s

60

60

s

9123DUPUFFMASTER3K9Medium Intensity Regimen1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

10123DUPUFFMASTER20231

Canadian Intense Regime


PUFFPROFPuff ProfileSQUARE
SQUARE

11123DUPUFFMASTER20232Canadian Intense Regime

PUFFDUR

Puff Duration

2.00

sec

2.00

2.00

sec

12123DUPUFFMASTER20233Canadian Intense Regime

PUFFINT

Puff Interval

4

PUFF/min

4

4

PUFF/min

13123DUPUFFMASTER20234

Canadian Intense Regime


PUFFBLCK

Puff Block

0

%

0

0

%

14123DUPUFFMASTER20235Canadian Intense Regime
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

15123DUPUFFMASTER20236Canadian Intense Regime
PUFFVOLPuff Volume

10

mL

10

10

mL

16123DUPUFFMASTER20237

Canadian Intense Regime


PUFFRNGPuff Range

100-200


100-200



17123DUPUFFMASTER20238Canadian Intense Regime1PUFFPAUSPuff Pause

60

s

60

60

s

18123DUPUFFMASTER20239Canadian Intense Regime1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

A1:


A2:                                   


RowSTUDYIDASSAYIDDOMAINTXSETCDGTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTC
1123MNvitGTA11RICCRelative Increase in Cell Count00%00%2022-05-25
2123MNvitGTA12RCCRelative Cell Count1540%00%2022-05-25
3123MNvitGTA13RPDRelative Population Doubling1540%00%2022-05-25
4123MNvitGTA14MNCELLSMicronucleated Cells220515Cells1515Cells2022-05-25
5123MNvitGTA15MNCELLSMicronucleated Cells247413Cells1313Cells2022-05-25
6123MNvitGTA16MNCELLSMicronucleated Cells275817Cells1717Cells2022-05-25
7123MNvitGTA17MNCELLSMicronucleated Cells266912Cells1212Cells2022-05-25
8123MNvitGTA18AVGRELAverage Relative MN Frequency
0.57%0.570.57%2022-05-25
9123MNvitGTA21RICCRelative Increase in Cell Count13415.7%15.715.7%2022-05-25
10123MNvitGTA22RCCRelative Cell Count13413.0%13.013.0%2022-05-25
11123MNvitGTA23RPDRelative Population Doubling1347.9%7.97.9%2022-05-25
12123MNvitGTA24MNCELLSMicronucleated Cells326620Cells2020Cells2022-05-25
13123MNvitGTA25MNCELLSMicronucleated Cells219017Cells1717Cells2022-05-25
14123MNvitGTA26MNCELLSMicronucleated Cells275813Cells1313Cells2022-05-25
15123MNvitGTA27MNCELLSMicronucleated Cells271421Cells2121Cells2022-05-25
16123MNvitGTA28AVGRELAverage Relative MN Frequency
0.66%0.660.66%2022-05-25
...













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