| Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF | TSVALCD | TSVCDREF | TSVCDVER |
|---|
| 1 | XYZ | TS | 1 |
| ACTSUB | Actual Number of Subjects | 304 |
|
|
|
|
| 2 | XYZ | TS | 1 |
| ADAPT | Adaptive Design | N |
|
|
|
|
| 3 | XYZ | TS | 1 |
| ADDON | Added on to Existing Treatments | Y |
| C49487 | CDISC CT | 2011-06-10 |
| 4 | XYZ | TS | 1 |
| AGEMAX | Planned Maximum Age of Subjects | PINF |
|
|
|
|
| 5 | XYZ | TS | 1 |
| AGEMIN | Planned Minimum Age of Subjects | P18MP18Y |
|
| ISO 8601 |
|
| 6 | XYZ | TS | 1 | PA | DCUTDTC | Data Cutoff Date | 2010-04-10 |
|
| ISO 8601 |
|
| 7 | XYZ | TS | 1 | PA | DCUTDESC | Data Cutoff Description | PRIMARY ANALYSIS |
|
|
|
|
| 8 | XYZ | TS | 1 |
| FCNTRY | Planned Country of Investigational Sites | USA |
|
| ISO 3166-1 Alpha-3 |
|
| 9 | XYZ | TS | 2 |
| FCNTRY | Planned Country of Investigational Sites | CAN |
|
| ISO 3166-1 Alpha-3 |
|
| 10 | XYZ | TS | 1 |
| HLTSUBJI | Healthy Subject Indicator | NA |
| C48660 | CDISC CT | 2011-06-10 |
| 11 | XYZ | TS | 1 |
| INDIC | Trial Disease/Condition Indication | Tobacco smoking consumption |
| 266918002 | SNOMED | 2011-03 |
| 12 | XYZ | TS | 1 |
| LENGTH | Trial Length | P3M |
|
| ISO 8601 |
|
| 13 | XYZ | TS | 1 |
| NARMS | Planned Number of Arms | 3 |
|
|
|
|
| 14 | XYZ | TS | 1 |
| OBJPRIM | Trial Primary Objective | Change in concentration of Nicotine in urine from baseline |
|
|
|
|
| 15 | XYZ | TS | 1 |
| OBJSEC | Trial Secondary Objective | Change in concentration of Cotinine in urine from baseline |
|
|
|
|
| 16 | XYZ | TS | 1 |
| PLANSUB | Planned Number of Subjects | 300 |
|
|
|
|
| 17 | XYZ | TS | 1 |
| RANDOM | Trial is Randomized | Y |
| C49488 | CDISC CT | 2011-06-10 |
| 18 | XYZ | TS | 1 |
| REGID | Registry Identifier | NCT123456789 |
| NCT123456789 | ClinicalTrials.gov |
|
| 19 | XYZ | TS | 2 |
| REGID | Registry Identifier | XXYYZZ456 |
| XXYYZZ456 | EudraCT |
|
| 20 | XYZ | TS | 1 |
| SENDTC | Study End Date | 2011-04-01 |
|
| ISO 8601 |
|
| 21 | XYZ | TS | 1 |
| SEXPOP | Sex of Participants | BOTH |
| C49636 | CDISC CT | 2011-06-10 |
| 22 | XYZ | TS | 1 |
| SPONSORAPPLCNT | Clinical Study SponsorApplicant | PharmacoTobaccoCo |
| | D-U-N-S NUMBER |
|
| 23 | XYZ | TS | 1 |
| STOPRULE | Study Stop Rules | NONE |
|
|
|
|
| 25 | XYZ | TS | 1 |
| TBLIND | Trial Blinding Schema | DOUBLE BLIND |
| C15228 | CDISC CT | 2011-06-10 |
| 26 | XYZ | TS | 1 |
| TCNTRL | Control Type | ACTIVE |
| C49649 | CDISC CT | 2011-06-10 |
| 27 | XYZ | TS | 1 |
| TITLE | Trial Title | A 3 month study of tobacco biomarkers in subjects using ENDS devices |
|
|
|
|
| 28 | XYZ | TS | 1 |
| TDIGRP | Diagnosis Group |
| NA |
|
|
|
| 30 | XYZ | TS | 1 |
| TINDTP | Trial Intent Type |
| NA | C49656 | CDISC CT | 2011-06-10 |
| 32 | XYZ | TS | 1 |
| TPHASE | Trial Phase Classification |
| NA |
|
|
|
| 33 | XYZ | TS | 1 |
| TTYPE | Trial Type | TOBACCO PRODUCT EFFECTPHARMACOKINETIC |
| xxxxxx | CDISC CT | xxxxxxxxx |
| 34 | XYZ | TS | 2 |
| TTYPE | Trial Type | SAFETY |
|
|
|
|
| 35 | XYZ | TS | 3 |
| TTYPE | Trial Type | PHARMACOKINETIC |
|
|
|
|
| 36 | XYZ | TS | 1 |
| SDTIGVER | SDTM IG Version | 3.4 |
|
|
|
|
| 37 | XYZ | TS | 1 |
| STDMVER | SDTM Version | 1.4 |
|
|
|
|
| 38 | XYZ | TS | 1 |
| TIGVER | Tobacco IG Version | 1.0 |
|
|
|
|