| 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| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-762 |
|---|
|
| Y |
| C49487 | CDISC CT | 2023-03-31 |
| 4 | XYZ | TS | 1 |
| AGEMAX | Planned Maximum Age of Subjects | PINF |
|
|
|
|
| 5 | XYZ | TS | 1 |
| AGEMIN | Planned Minimum Age of Subjects | P18Y |
|
| 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 | NOT APPLICABLE | C48660 | CDISC CT | 2023-03-31 |
| 11 | XYZ | TS | 1 | INDIC | Trial Disease/Condition Indication | Tobacco smoking consumption |
| 266918002 | SNOMED | 2011-03 |
| 1211 | XYZ | TS | 1 |
| LENGTH | Trial Length | P3M |
|
| ISO 8601 |
|
| 1312 | XYZ | TS | 1 |
| NARMS | Planned Number of Arms | 3 |
|
|
|
|
| 1413 | XYZ | TS | 1 |
| OBJPRIM | Trial Primary Objective | Change in concentration of Nicotine in urine from baseline |
|
|
|
|
| 1514 | XYZ | TS | 1 |
| OBJSEC | Trial Secondary Objective | Change in concentration of Cotinine in urine from baseline |
|
|
|
|
| 1615 | XYZ | TS | 1 |
| PLANSUB | Planned Number of Subjects | 300 |
|
|
|
|
| 1716 | XYZ | TS | 1 |
| RANDOM | Trial is Randomized | Y |
| C49488 | CDISC CT | 2023-03-31 |
| 1817 | XYZ | TS | 1 |
| REGID | Registry Identifier | NCT123456789 |
| NCT123456789 | ClinicalTrials.gov |
|
| 1918 | XYZ | TS | 2 |
| REGID | Registry Identifier | XXYYZZ456 |
| XXYYZZ456 | EudraCT |
|
| 2019 | XYZ | TS | 1 |
| SENDTC | Study End Date | 2011-04-01 |
|
| ISO 8601 |
|
| 2120 | XYZ | TS | 1 |
| SEXPOP | Sex of Participants | BOTH |
| C49636 | CDISC CT | 2023-03-31 |
| 2221 | XYZ | TS | 1 |
| APPLCNT | | TobaccoCo |
| | D-U-N-S NUMBER |
|
| 2322 | XYZ | TS | 1 |
| STOPRULE | Study Stop Rules | NONE |
|
|
|
|
| 2423 | XYZ | TS | 1 |
| TBLIND | Trial Blinding Schema | DOUBLE BLIND |
| C15228 | CDISC CT | 2023-03-31 |
| XYZ | TS | 1 |
| TCNTRL | Control Type | ACTIVE |
| C49649 | CDISC CT | 2023-03-31 |
| 2625 | XYZ | TS | 1 |
| TITLE | Trial Title | A 3 month study of tobacco biomarkers in subjects using ENDS devices |
|
|
|
|
| 2726 | XYZ | TS | 1 |
| TDIGRP | Diagnosis Group |
| NA |
|
|
|
| 2827 | XYZ | TS | 1 |
| TINDTP | Trial Intent Type |
| NA | C49656 | CDISC CT | 2023-03-31 |
| 2928 | XYZ | TS | 1 |
| TPHASE | Trial Phase Classification | NOT APPLICABLE |
|
|
|
|
| 3029 | XYZ | TS | 1 |
| TTYPE | Trial Type | PHARMACOKINETIC |
| C49663 | CDISC CT | 2023-03-3131 |
| 30 | XYZ | TS | 1 |
| STYPE | Study Type | INTERVENTIONAL |
| C98388 | CDISC CT | 2023-03-31 |
| 3231 | XYZ | TS | 1 |
| SDTIGVER | SDTM IG Version | 3.4 |
|
|
|
|
| 3332 | XYZ | TS | 1 |
| STDMVER | SDTM Version | 1.4 |
|
|
|
|
| 3433 | XYZ | TS | 1 |
| TIGVER | Tobacco IG Version | 1.0 |
|
|
|
|