...
TSVALNF contains a “null flavor,” a value that provides additional coded information when TSVAL is null. For example, for TSPARM = "AGEMAX" (Planned Maximum Age of Subjects), there is no value if a study does not specify a maximum age. In this case, the appropriate null flavor is "PINF", which stands for "positive infinity." In a tobacco study conducted in healthy volunteers where the trial phase classification is not established, the null flavor value (TSVAL) for TSPARM = "TPHASE" would be "NANOT APPLICABLE" (i. e., not applicable). | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-697 |
|---|
|
TSVALNF can also be used in a case where the value of a particular parameter is unknown.
...
| Dataset wrap |
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|
| Dataset2 |
|---|
| 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 | 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 | NA |
| C48660 | CDISC CT | 2023-03-31 | | 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 | 2023-03-31 | | 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 | 2023-03-31 | | 22 | XYZ | TS | 1 |
| APPLCNT | Applicant | Jira |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-321 |
|---|
|
| TobaccoCo |
| | D-U-N-S NUMBER |
| | 23 | XYZ | TS | 1 |
| STOPRULE | Study Stop Rules | NONE |
|
|
|
| | 24 | 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 | | 26 | XYZ | TS | 1 |
| TITLE | Trial Title | A 3 month study of tobacco biomarkers in subjects using ENDS devices |
|
|
|
| | 27 | XYZ | TS | 1 |
| TDIGRP | Diagnosis Group |
| NA |
|
|
| | 28 | XYZ | TS | 1 |
| TINDTP | Trial Intent Type |
| NA | C49656 | CDISC CT | 2023-03-31 | | 29 | XYZ | TS | 1 |
| TPHASE | Trial Phase Classification | NANOT APPLICABLE |
|
|
|
| | 30 | XYZ | TS | 1 |
| TTYPE | Trial Type | PHARMACOKINETIC |
| C49663 | CDISC CT | 2023-03-31 | | 31 | XYZ | TS | 1 |
| STYPE | Study Type | INTERVENTIONAL |
| C98388 | CDISC CT | 2023-03-31 | | 32 | XYZ | TS | 1 |
| SDTIGVER | SDTM IG Version | 3.4 |
|
|
|
| | 33 | XYZ | TS | 1 |
| STDMVER | SDTM Version | 1.4 |
|
|
|
| | 34 | XYZ | TS | 1 |
| TIGVER | Tobacco IG Version| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-322 |
|---|
|
| 1.0 |
|
|
|
|
|
|