...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-9: | Show the PTTEST of Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test. | | Rows 10-18: | Show the PTTEST of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1. The PTGRPID is used to tie together a block of related records in a single domain. | |
| Dataset2 |
|---|
| Row |
|
| STUDYID | DOMAIN | SPTOBID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM |
|---|
| 1 |
|
| TOB07 | PT | Smokeless01 | 111 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 51.93 | % | 51.93 | 51.93 | % | TOBACCO |
|
| 1 | Week 0 | 1 | | 2 |
|
| TOB07 | PT | Smokeless01 | 112 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 51.96 | % | 51.96 | 51.96 | % | TOBACCO |
|
| 2 | Week 0 | 1 | | 3 |
|
| TOB07 | PT | Smokeless01 | 113 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 51.98 | % | 51.98 | 51.98 | % | TOBACCO |
|
| 3 | Week 0 | 1 | | 4 |
|
| TOB07 | PT | Smokeless01 | 114 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 51.75 | % | 51.75 | 51.75 | % | TOBACCO |
|
| 1 | Week 8 | 4 | | 5 |
|
| TOB07 | PT | Smokeless01 | 115 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 51.75 | % | 51.75 | 51.75 | % | TOBACCO |
|
| 2 | Week 8 | 4 | | 6 |
|
| TOB07 | PT | Smokeless01 | 116 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 51.67 | % | 51.67 | 51.67 | % | TOBACCO |
|
| 3 | Week 8 | 4 | | 7 |
|
| TOB07 | PT | Smokeless01 | 117 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 52.05 | % | 52.05 | 52.05 | % | TOBACCO |
|
| 1 | Week 48 | 9 | | 8 |
|
| TOB07 | PT | Smokeless01 | 118 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 52.68 | % | 52.68 | 52.68 | % | TOBACCO |
|
| 2 | Week 48 | 9 | | 9 |
|
| TOB07 | PT | Smokeless01 | 119 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | 52.21 | % | 52.21 | 52.21 | % | TOBACCO |
|
| 3 | Week 48 | 9 | | 10 |
|
| TOB07 | PT | Smokeless01 | 120 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 51.93 | % | 51.93 | 51.93 | % | TOBACCO |
|
| 1 | Week 0 | 1 | | 11 |
|
| TOB07 | PT | Smokeless01 | 121 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 51.96 | % | 51.96 | 51.96 | % | TOBACCO |
|
| 2 | Week 0 | 1 | | 12 |
|
| TOB07 | PT | Smokeless01 | 122 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 51.98 | % | 51.98 | 51.98 | % | TOBACCO |
|
| 3 | Week 0 | 1 | | 13 |
|
| TOB07 | PT | Smokeless01 | 123 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 51.80 | % | 51.80 | 51.80 | % | TOBACCO |
|
| 1 | Week 8 | 4 | | 14 |
|
| TOB07 | PT | Smokeless01 | 124 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 51.77 | % | 51.77 | 51.77 | % | TOBACCO |
|
| 2 | Week 8 | 4 | | 15 |
|
| TOB07 | PT | Smokeless01 | 125 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 51.84 | % | 51.84 | 51.84 | % | TOBACCO |
|
| 3 | Week 8 | 4 | | 16 |
|
| TOB07 | PT | Smokeless01 | 126 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 52.18 | % | 52.18 | 52.18 | % | TOBACCO |
|
| 1 | Week 48 | 9 | | 17 |
|
| TOB07 | PT | Smokeless01 | 127 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 52.21 | % | 52.21 | 52.21 | % | TOBACCO |
|
| 2 | Week 48 | 9 | | 18 |
|
| TOB07 | PT | Smokeless01 | 128 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | 51.87 | % | 51.87 | 51.87 | % | TOBACCO |
|
| 3 | Week 48 | 9 |
|
|
From previous page: - update for this example.... values are likely different - ??? - Condition 1 and Condition 2
The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset.
The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TCPARMCD/TCPARM. TCVAL and TCVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above.
(We've added TCVALU which was not originally part of the TC draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TCVALU)
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | RDOMAIN | TCVAR1 | TCVRVAL1 | TCSEQ | TCGRPID | TCPARMCD | TCPARM | TCVAL | TCVALU |
|---|
| 1 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 1 |
| PUFFPROF | Puff Profile | SQUARE |
| | 2 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 2 |
| PUFFDUR | Puff Duration | 1.25 | sec | | 3 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 3 |
| PUFFINT | Puff Interval | 3 | PUFF/min | | 4 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 4 |
| PUFFBLCK | Puff Block | 25 | % | | 5 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 5 |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | | 6 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 6 |
| PUFFVOL | Puff Volume | 10 | mL | | 7 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 7 |
| PUFFRNG | Puff Range | 100-200 |
| | 8 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 8 | 1 | PUFFPAUS | Puff Pause | 60 | s | | 9 | TOB07 | TC | PT | PTTSTCND | Smokeless Standard (Long Term) Condition | 9 | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF |
|
|