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. Each usage was recorded. 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.
ex.xpt
ex.xpt
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
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
EX
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
0
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
0
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
0
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
0
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
0
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
0
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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