Treatment Duration will be controlled? During CT definition/reviews will need to decide appropriate Treatment duration values; For now, we just include good example values based on our experience Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | MNvit | TX | A1 |
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| METACT | Metabolic Activation (should there be two parms? Presence, type)? | +S9 | 2 | 123 | MNvit | TX | A1 |
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| TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) | 3 |
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| TRTDRTOL | Treatment Duration Tolerance |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | H |
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| INTRVN | name of the intervention article | Bleomycin or Cyclophosphamid A |
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| ITVTYPE | type of intervention article | choices of values: product; negative control; positive control | 3 | 123 | MNvit | TX | A1 |
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| PRDCONCITVCONC | Concentration of producti a | 0 | 4 | 123 | MNvit | TX | A1 |
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| PRDCONCUITVCONCU | Concentration Unit | ug/ml | 5 | 123 | MNvit | TX | A1 |
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| Product | Product Name |
| 6 | 123 | MNvit | TX | A1 |
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| Smoking Regime |
| 7 | 123 | MNvit | TX | A1 |
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| Smoke Fraction |
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| 123 | MNvit | TX | A2 |
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| METACT | Metabolic Activation | +S9 |
| 123 | MNvit | TX | A2 |
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| TRTDUR | Treatment Duration | Short Term |
| 123 | MNvit | TX | A2 |
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| PRDCONC | Concentration of product | 1250 |
| 123 | MNvit | TX | A2 |
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| PRDCONCU | Concentration Unit | ug/ml |
| 123 | MNvit | TX | A2 |
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| Product | Product Name |
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| 123 | MNvit | TX | A2 |
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| Smoking Regime |
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| 123 | MNvit | TX | A2 |
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| Smoke Fraction |
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| A6 |
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| METACT |
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| TRTDUR |
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| INTRVN | name of the intervention article | Cyclophosphamid A |
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| ITVTYPE | type of intervention article | Positive control |
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| ITVCONC | Concentration of i a | 5 |
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| A6 |
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| ITVCONCU | Concentration Unit | ug/ml |
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| A6 |
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| TCNTL |
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| 123 | MNvit | TX | B1 |
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| METACT | Metabolic Activation | -S9 |
| 123 | MNvit | TX | B1 |
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| TRTDRTRG | Treatment Duration target | 4 |
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| TRTDRTOL | Treatment Duration Tolerance | .25 | ?? | 123 | MNvit | TX | B1 |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | H |
| 123 | MNvit | TX | B1 |
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| PRDCONC | Concentration of product | 0 |
| 123 | MNvit | TX | B1 |
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| PRDCONCU | Concentration Unit | ug/ml |
| 123 | MNvit | TX | B1 |
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| Product | Product Name |
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| 123 | MNvit | TX | B1 |
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| Smoking Regime |
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| 123 | MNvit | TX | B1 |
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| Smoke Fraction |
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| 123 | MNvit | TX | C1 |
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| METACT | Metabolic Activation | -S9 |
| 123 | MNvit | TX | C1 |
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| TRTDUR | Treatment Duration | 24 | ?? | 123 | MNvit | TX | C1 |
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| TRTDURU | Treatment Duration Unit | H |
| 123 | MNvit | TX | C1 |
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| PRDCONC | Concentration of product | 0 |
| 123 | MNvit | TX | C1 |
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| PRDCONCU | Concentration Unit | ug/ml |
| 123 | MNvit | TX | C1 |
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| Product | Product Name |
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| 123 | MNvit | TX | C1 |
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| Smoking Regime |
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| 123 | MNvit | TX | C1 |
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| Smoke Fraction |
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