This is an example of a crossover study testing 7 smokeless tobacco products. All products contain nicotine except for product F, which was a nicotine/tobacco free product. Each subject first used the product ad libitum and the next day the product usage was evaluated in the morning, as specified in the protocol. The subjects were confined to the site. Products were supplied to the subjects as needed by site staff. Each usage was recorded. The applicant did not submit a Product Accountability (DA) domain, nor an EC domain. The name of the "actual product" would be used but a dummy name was used in the example below.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXCAT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXPSTRG | EXPSTRGU | VISITNUM | VISIT | VISITDY | EPOCH | EXSTDTC | EXENDTC |
|---|
| 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 2019-06-27T14:29:13 | 2019-06-27T14:54:53 | | 3 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 3 | PRODUCT C | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 11 | DAY 1 | 1 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | 0 | mg | 15 | DAY 5 | 5 | PRODUCT EXPOSURE | 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 | 0 | mg | 15 | DAY 5 | 5 | PRODUCT EXPOSURE | 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 | 0 | mg | 16 | DAY 6 | 6 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | 0 | mg | 13 | DAY 3 | 3 | PRODUCT EXPOSURE | 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 | 0 | mg | 14 | DAY 4 | 4 | PRODUCT EXPOSURE | 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 | 0 | mg | 14 | DAY 4 | 4 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 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 | PRODUCT EXPOSURE | 2019-07-11T08:00:00 | 2019-07-11T08:30:00 |
|
|