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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 clinical pharmacology tobacco study conducted in healthy volunteers for a drug where indications are not yet established, the appropriate the Trial Phase Classification is not established the null flavor for TSPARM = "INDIC" (Trial Disease/Condition Indication) TPHASE" would be "NA" (i.e., not applicable). TSVALNF can also be used in a case where the value of a particular parameter is unknown.
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Dataset2 |
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Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVAL1 | TSVALNF | TSVALCD | TSVCDREF | TSVCDVER |
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1 | XYZ | TS | 1 |
| ACTSUB | Actual Number of Subjects | 304 |
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| 2 | XYZ | TS | 1 |
| ADAPT | Adaptive Design | N |
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| 3 | XYZ | TS | 1 |
| ADDON | Added on to Existing Treatments | Y |
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| C49487 | CDISC CT | 2011-06-10 | 4 | XYZ | TS | 1 |
| AGEMAX | Planned Maximum Age of Subjects | P70Y | ISO 8601PINF |
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| 5 | XYZ | TS | 1 |
| AGEMIN | Planned Minimum Age of Subjects | P18M |
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| ISO 8601 |
| 6 | XYZ | TS | 1 | PA | DCUTDTC | Data Cutoff Date | 2010-04-10 |
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| ISO 8601 |
| 7 | XYZ | TS | 1 | PA | DCUTDESC | Data Cutoff Description | PRIMARY ANALYSIS |
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| 8 | XYZ | TS | 1 |
| FCNTRY | Planned Country of Investigational Sites | USA |
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| ISO 3166-1 Alpha-3 |
| 9 | XYZ | TS | 2 |
| FCNTRY | Planned Country of Investigational Sites | CAN |
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| 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 |
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| ISO 8601 |
| 13 | XYZ | TS | 1 |
| NARMS | Planned Number of Arms | 3 |
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| 14 | XYZ | TS | 1 |
| OBJPRIM | Trial Primary Objective | Change in concentration of Nicotine in urine from baseline |
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| 15 | XYZ | TS | 1 |
| OBJSEC | Trial Secondary Objective | Change in concentration of Cotinine in urine from baseline |
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| 16 | XYZ | TS | 1 |
| PLANSUB | Planned Number of Subjects | 300 |
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| 17 | XYZ | TS | 1 |
| RANDOM | Trial is Randomized | Y |
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| C49488 | CDISC CT | 2011-06-10 | 18 | XYZ | TS | 1 |
| REGID | Registry Identifier | NCT123456789 |
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| NCT123456789 | ClinicalTrials.gov |
| 19 | XYZ | TS | 2 |
| REGID | Registry Identifier | XXYYZZ456 |
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| XXYYZZ456 | EudraCT |
| 20 | XYZ | TS | 1 |
| SENDTC | Study End Date | 2011-04-01 |
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| ISO 8601 |
| 21 | XYZ | TS | 1 |
| SEXPOP | Sex of Participants | BOTH |
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| C49636 | CDISC CT | 2011-06-10 | 22 | XYZ | TS | 1 |
| SPONSOR | Clinical Study Sponsor | Pharmaco |
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| | D-U-N-S NUMBER |
| 23 | XYZ | TS | 1 |
| STOPRULE | Study Stop Rules | NONE |
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| 24 | XYZ | TS | 1 |
| TITLE | Trial Title | A 3 month study of tobacco biomarkers in subjects using ENDS devices |
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| 25 | XYZ | TS | 1 |
| TBLIND | Trial Blinding Schema | DOUBLE BLIND |
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| C15228 | CDISC CT | 2011-06-10 | 26 | XYZ | TS | 1 |
| TCNTRL | Control Type | ACTIVE |
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| 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 |
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| 28 | XYZ | TS | 1 |
| TDIGRP | Diagnosis Group |
|
| NA |
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| 29 | XYZ | TS | 1 |
| INDIC | Trial Disease/Condition Indication | Tobacco smoking consumption |
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| 266918002 | SNOMED | 2011-03 | 30 | XYZ | TS | 1 |
| TINDTP | Trial Intent Type |
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| NA | C49656 | CDISC CT | 2011-06-10 | 31 | XYZ | TS | 1 |
| TITLE | Trial Title | A 3 month study of tobacco biomarkers in subjects using ENDS devices |
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| 32 | XYZ | TS | 1 |
| TPHASE | Trial Phase Classification |
|
| NA |
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| 33 | XYZ | TS | 1 |
| TTYPE | Trial Type | TOBACCO PRODUCT EFFECT |
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| xxxxxx | CDISC CT | xxxxxxxxx | 34 | XYZ | TS | 2 |
| TTYPE | Trial Type | SAFETY |
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| 35 | XYZ | TS | 3 |
| TTYPE | Trial Type | PHARMACOKINETIC |
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| 36 | XYZ | TS | 1 |
| SDTIGVER | SDTM IG Version | 3.4 |
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| 37 | XYZ | TS | 2 |
| STDMVER | SDTM Version | 1.4 |
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| 38 | XYZ | TS | 3 |
| TIG Version | Tobacco IG Version | 1.0 |
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