This an example of a cross-over study where 7 smokeless tobacco products were tested. All product contain nicotine except for product F, which was a nicotine/tobacco free product. Subject used the product ad libitum and then the next day the product was evaluated as specified in the protocol in the morning. The subjects were confined to the site. Product were supplied to the subject as needed by site staff. The sponsor did not submit a Product Accountability (DA) domain, or the EC domain. The name of the actual product was not used in the example below.
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXCAT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXPSTRG | EXPSTRGU | VISITNUM | VISIT | VISITDY | EPOCH | EXSTDTC | EXENDTC |
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| 1 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 1 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 10 | DAY -1 | -1 | TREATMENT | 2019-06-27T13:10:33 | 2019-06-27T13:38:49 | | 2 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 2 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 10 | DAY -1 | -1 | TREATMENT | 2019-06-27T14:29:13 | 2019-06-27T14:54:53 | | 3 | ALCS-REG-STUDY | EXC | ALCS-REG-STUDY_10001 | 3 | PRODUCT C | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 11 | DAY 1 | 1 | TREATMENT | 2019-06-28T08:00:12 | 2019-06-28T08:30:21 | | 4 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 4 | PRODUCT E | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 11 | DAY 1 | 1 | TREATMENT | 2019-06-28T14:01:52 | 2019-06-28T14:55:27 | | 5 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 5 | PRODUCT E | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 11 | DAY 1 | 1 | TREATMENT | 2019-06-28T15:18:35 | 2019-06-28T15:57:33 | | 6 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 6 | PRODUCT E | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 12 | DAY 2 | 2 | TREATMENT | 2019-06-29T08:00:08 | 2019-06-29T08:30:13 | | 7 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 7 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 12 | DAY 2 | 2 | TREATMENT | 2019-06-29T14:01:50 | 2019-06-29T14:50:11 | | 8 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 8 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 12 | DAY 2 | 2 | TREATMENT | 2019-06-29T15:24:33 | 2019-06-29T15:59:46 | | 9 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 9 | PRODUCT B | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 13 | DAY 3 | 3 | TREATMENT | 2019-06-30T08:00:00 | 2019-06-30T08:30:00 | | 10 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 10 | PRODUCT D | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 13 | DAY 3 | 3 | TREATMENT | 2019-06-30T14:12:32 | 2019-06-30T14:47:47 | | 11 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 11 | PRODUCT D | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 13 | DAY 3 | 3 | TREATMENT | 2019-06-30T15:24:46 | 2019-06-30T16:04:57 | | 12 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 12 | PRODUCT D | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 14 | DAY 4 | 4 | TREATMENT | 2019-07-01T08:00:00 | 2019-07-01T08:30:00 | | 13 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 13 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 14 | DAY 4 | 4 | TREATMENT | 2019-07-01T14:02:36 | 2019-07-01T14:47:33 | | 14 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 14 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 14 | DAY 4 | 4 | TREATMENT | 2019-07-01T15:37:45 | 2019-07-01T15:58:15 | | 15 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 15 | PRODUCT A | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 15 | DAY 5 | 5 | TREATMENT | 2019-07-02T08:00:00 | 2019-07-02T08:30:01 | | 16 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 16 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 20 | mg | 15 | DAY 5 | 5 | TREATMENT | 2019-07-02T14:11:00 | 2019-07-02T14:54:08 | | 17 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 17 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 20 | mg | 15 | DAY 5 | 5 | TREATMENT | 2019-07-02T15:38:52 | 2019-07-02T15:59:50 | | 18 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 18 | PRODUCT F | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 20 | mg | 16 | DAY 6 | 6 | TREATMENT | 2019-07-03T08:00:00 | 2019-07-03T08:30:00 | | 19 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 19 | PRODUCT G | UNCONTROLLED PRODUCT USE | 3.37 | g | QUID | ORAL | 4 | mg | 16 | DAY 6 | 6 | TREATMENT | 2019-07-03T14:13:14 | 2019-07-03T14:57:40 | | 20 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 20 | PRODUCT G | UNCONTROLLED PRODUCT USE | 3.2 | g | QUID | ORAL | 4 | mg | 16 | DAY 6 | 6 | TREATMENT | 2019-07-03T15:35:01 | 2019-07-03T16:07:25 | | 21 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 21 | PRODUCT G | CONTROLLED PRODUCT USE | 2 | g | QUID | ORAL | 4 | mg | 17 | DAY 7/EARLY TERMINATION | 7 | TREATMENT | 2019-07-04T08:00:04 | 2019-07-04T08:30:05 | | 22 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 1 | PRODUCT E | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 10 | DAY -1 | -1 | TREATMENT | 2019-07-04T14:06:09 | 2019-07-04T14:14:14 | | 23 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 2 | PRODUCT E | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 11 | DAY 1 | 1 | TREATMENT | 2019-07-05T08:00:00 | 2019-07-05T08:30:00 | | 24 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 3 | PRODUCT D | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 11 | DAY 1 | 1 | TREATMENT | 2019-07-05T14:02:39 | 2019-07-05T14:18:57 | | 25 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 4 | PRODUCT D | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 12 | DAY 2 | 2 | TREATMENT | 2019-07-06T08:00:00 | 2019-07-06T08:30:00 | | 26 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 5 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 12 | DAY 2 | 2 | TREATMENT | 2019-07-06T14:00:00 | 2019-07-06T14:08:40 | | 27 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 6 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 12 | DAY 2 | 2 | TREATMENT | 2019-07-06T15:52:53 | 2019-07-06T15:59:21 | | 28 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 7 | PRODUCT C | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 13 | DAY 3 | 3 | TREATMENT | 2019-07-07T08:00:00 | 2019-07-07T08:30:00 | | 29 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 8 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 13 | DAY 3 | 3 | TREATMENT | 2019-07-07T14:01:12 | 2019-07-07T14:12:25 | | 30 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 9 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 20 | mg | 13 | DAY 3 | 3 | TREATMENT | 2019-07-07T14:57:49 | 2019-07-07T15:07:07 | | 31 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 10 | PRODUCT F | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 20 | mg | 14 | DAY 4 | 4 | TREATMENT | 2019-07-08T08:00:00 | 2019-07-08T08:30:00 | | 32 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 11 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 20 | mg | 14 | DAY 4 | 4 | TREATMENT | 2019-07-08T14:00:52 | 2019-07-08T14:17:31 | | 33 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 12 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 14 | DAY 4 | 4 | TREATMENT | 2019-07-08T14:46:07 | 2019-07-08T14:53:43 | | 34 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 13 | PRODUCT B | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 15 | DAY 5 | 5 | TREATMENT | 2019-07-09T08:00:01 | 2019-07-09T08:30:01 | | 35 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 14 | PRODUCT G | UNCONTROLLED PRODUCT USE | 2.69 | g | QUID | ORAL | 4 | mg | 15 | DAY 5 | 5 | TREATMENT | 2019-07-09T14:06:24 | 2019-07-09T14:30:16 | | 36 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 15 | PRODUCT G | UNCONTROLLED PRODUCT USE | 3.3 | g | QUID | ORAL | 4 | mg | 15 | DAY 5 | 5 | TREATMENT | 2019-07-09T14:49:39 | 2019-07-09T15:15:16 | | 37 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 16 | PRODUCT G | CONTROLLED PRODUCT USE | 2 | g | QUID | ORAL | 4 | mg | 16 | DAY 6 | 6 | TREATMENT | 2019-07-10T08:00:00 | 2019-07-10T08:30:00 | | 38 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 17 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 16 | DAY 6 | 6 | TREATMENT | 2019-07-10T14:02:07 | 2019-07-10T14:35:40 | | 39 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 18 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 16 | DAY 6 | 6 | TREATMENT | 2019-07-10T15:27:37 | 2019-07-10T15:58:24 | | 40 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 19 | PRODUCT A | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 17 | DAY 7/EARLY TERMINATION | 7 | TREATMENT | 2019-07-11T08:00:00 | 2019-07-11T08:30:00 |
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