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titledu.xpt smoke regimen definition (a findings domain for 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

  • 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"

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



Expand
titleeiou.xpt Entity Identifiers (dm-like)
A1-8-3
RowSTUDYIDASSAYIDDOMAINSETCD (from TX)EUIDOBUID
1123MNvitEIA11-8-32123MNvitEIC0
23123MNvitEIA12-9-34123MNvitEIA23-7-15123MNvitEIA22-7-1A2C1250



Expand
titlegt.xpt (similar to LB)

A1:


A2:                                   


  • Different runs would be expected to have different ENID and GTDTC values. In ei.xpt, these are distinguished by different RUNID values.
RowSTUDYIDASSAYIDDOMAINEUID

OBUID??


GTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESU

GTCOLSRT

???

GTSTRESCGTSTRESNGTSTRESUGTDTC
1123MNvitGT1-8-3C0
1RICCRelative Increase in Cell Count1540%
00%2022-05-25
2123MNvitGT1-8-3C0
2RCCRelative Cell Count1540%
00%2022-05-25
3123MNvitGT1-8-3C0
3RPDRelative Population Doubling1540%
00%2022-05-25
4123MNvitGT1-8-3C0
4MNCELLSMicronucleated Cells220515Cells
1515Cells2022-05-25
5123MNvitGT1-8-3C0
5MNCELLSMicronucleated Cells247413Cells
1313Cells2022-05-25
6123MNvitGT1-8-3C0
6MNCELLSMicronucleated Cells275817Cells
1717Cells2022-05-25
7123MNvitGT1-8-3C0
7MNCELLSMicronucleated Cells266912Cells
1212Cells2022-05-25
8123MNvitGT1-8-3C0
8AVGRELAverage Relative MN Frequency
0.57%
0.570.57%2022-05-25
9123MNvitGT2-8-3C1250
1RICCRelative Increase in Cell Count13415.7%
15.715.7%2022-05-25
10123MNvitGT2-8-3C1250
2RCCRelative Cell Count13413.0%
13.013.0%2022-05-25
11123MNvitGT2-8-3C1250
3RPDRelative Population Doubling1347.9%
7.97.9%2022-05-25
12123MNvitGT2-8-3C1250
4MNCELLSMicronucleated Cells326620Cells
2020Cells2022-05-25
13123MNvitGT2-8-3C1250
5MNCELLSMicronucleated Cells219017Cells
1717Cells2022-05-25
14123MNvitGT2-8-3C1250
6MNCELLSMicronucleated Cells275813Cells
1313Cells2022-05-25
15123MNvitGT2-8-3C1250
7MNCELLSMicronucleated Cells271421Cells
2121Cells2022-05-25
16123MNvitGT2-8-3C1250
8AVGRELAverage Relative MN Frequency
0.66%
0.660.66%2022-05-25
...