Trial Outcomes & Findings for A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products. (NCT NCT03692078)
NCT ID: NCT03692078
Last Updated: 2024-11-25
Results Overview
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
231 participants
Primary outcome timeframe
Baseline (Day -1), Day 5 and Day 7
Results posted on
2024-11-25
Participant Flow
Subjects were required to complete a test product tolerability trial and baseline assessment over the course of 3 days prior to randomization on Day 1 of the study. A total of 213 subjects were randomized to one of the six groups in this study.
Participant milestones
| Measure |
Product Trial
Subjects were enrolled in the product trial period but discontinued from the study prior to randomization.
|
GROUP 1: Continue Smoking
Subjects will be asked to continue smoking their OB cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product
|
GROUP 3: OTDN Product 2
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product
|
GROUP 4: OTDN Product 1
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product
|
GROUP 5: OTDN Product 2
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product
|
GROUP 6: Tobacco Cessation
Subjects will completely stop all tobacco product usage for 7 days.
Tobacco Cessation: Tobacco Cessation
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
40
|
42
|
41
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
0
|
38
|
42
|
40
|
25
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
18
|
2
|
0
|
1
|
5
|
4
|
3
|
Reasons for withdrawal
| Measure |
Product Trial
Subjects were enrolled in the product trial period but discontinued from the study prior to randomization.
|
GROUP 1: Continue Smoking
Subjects will be asked to continue smoking their OB cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product
|
GROUP 3: OTDN Product 2
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product
|
GROUP 4: OTDN Product 1
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product
|
GROUP 5: OTDN Product 2
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product
|
GROUP 6: Tobacco Cessation
Subjects will completely stop all tobacco product usage for 7 days.
Tobacco Cessation: Tobacco Cessation
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Enrollment Closed
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Failure To Meet Randomization Criteria
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
5
|
3
|
3
|
Baseline Characteristics
A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.
Baseline characteristics by cohort
| Measure |
Product Trial
n=18 Participants
All subjects who used a study product during the product trial period, including subjects who were discontinued from the study before randomization and subjects who were randomized to one of the six study groups.
|
GROUP 1: Continue Smoking
n=40 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 4: OTDN Product 1
n=30 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 5: OTDN Product 2
n=30 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=30 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
36.6 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 12.29 • n=4 Participants
|
38.3 years
STANDARD_DEVIATION 12.62 • n=21 Participants
|
38.2 years
STANDARD_DEVIATION 13.09 • n=10 Participants
|
41.5 years
STANDARD_DEVIATION 8.11 • n=115 Participants
|
39.8 years
STANDARD_DEVIATION 11.72 • n=6 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
96 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
135 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
19 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
212 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian and Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian, Black, White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
80 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black, White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
143 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian, White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Weight
|
78.46 kg
STANDARD_DEVIATION 15.918 • n=5 Participants
|
84.07 kg
STANDARD_DEVIATION 15.491 • n=7 Participants
|
84.81 kg
STANDARD_DEVIATION 16.063 • n=5 Participants
|
86.75 kg
STANDARD_DEVIATION 19.738 • n=4 Participants
|
83.84 kg
STANDARD_DEVIATION 18.142 • n=21 Participants
|
78.57 kg
STANDARD_DEVIATION 15.467 • n=10 Participants
|
86.82 kg
STANDARD_DEVIATION 13.220 • n=115 Participants
|
84.31 kg
STANDARD_DEVIATION 16.614 • n=6 Participants
|
|
Height
|
168.6 cm
STANDARD_DEVIATION 10.19 • n=5 Participants
|
172.7 cm
STANDARD_DEVIATION 7.69 • n=7 Participants
|
171.7 cm
STANDARD_DEVIATION 8.96 • n=5 Participants
|
172.2 cm
STANDARD_DEVIATION 9.36 • n=4 Participants
|
170.4 cm
STANDARD_DEVIATION 9.86 • n=21 Participants
|
171.6 cm
STANDARD_DEVIATION 8.32 • n=10 Participants
|
171.3 cm
STANDARD_DEVIATION 9.15 • n=115 Participants
|
171.7 cm
STANDARD_DEVIATION 8.82 • n=6 Participants
|
|
Body Mass Index (BMI)
|
27.656 kg/m²
STANDARD_DEVIATION 5.3195 • n=5 Participants
|
28.130 kg/m²
STANDARD_DEVIATION 4.6162 • n=7 Participants
|
28.679 kg/m²
STANDARD_DEVIATION 4.6677 • n=5 Participants
|
29.134 kg/m²
STANDARD_DEVIATION 5.4869 • n=4 Participants
|
28.847 kg/m²
STANDARD_DEVIATION 5.3881 • n=21 Participants
|
26.670 kg/m²
STANDARD_DEVIATION 5.1232 • n=10 Participants
|
29.693 kg/m²
STANDARD_DEVIATION 4.7754 • n=115 Participants
|
28.547 kg/m²
STANDARD_DEVIATION 5.0294 • n=6 Participants
|
|
Highest Grade of School
Elementary School
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
Highest Grade of School
Some High School
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
27 Participants
n=6 Participants
|
|
Highest Grade of School
High School Graduate
|
5 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
101 Participants
n=6 Participants
|
|
Highest Grade of School
1-3 Years College
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
72 Participants
n=6 Participants
|
|
Highest Grade of School
4+ Years College
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
|
Highest Grade of School
Postgraduate/Masters/Doctorate/Law/MD
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
|
Highest Grade of School
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Highest Grade of School
Do Not Wish to Answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Annual Income
Under $20,000
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
87 Participants
n=6 Participants
|
|
Annual Income
$20,000 - $29,999
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
60 Participants
n=6 Participants
|
|
Annual Income
$30,000 - $39,999
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
41 Participants
n=6 Participants
|
|
Annual Income
$40,000 - $49,999
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
|
Annual Income
$50,000 - $59,999
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
Annual Income
$60,000 - $74,999
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
|
Annual Income
$75,000 - $99,999
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Annual Income
$100,000 - $149,999
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Annual Income
Do Not Wish to Answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
|
Daily Cigarette Use
|
16.8 Cigarettes per day
STANDARD_DEVIATION 5.92 • n=5 Participants
|
16.8 Cigarettes per day
STANDARD_DEVIATION 4.61 • n=7 Participants
|
17.8 Cigarettes per day
STANDARD_DEVIATION 6.02 • n=5 Participants
|
18.4 Cigarettes per day
STANDARD_DEVIATION 5.99 • n=4 Participants
|
15.9 Cigarettes per day
STANDARD_DEVIATION 3.53 • n=21 Participants
|
16.7 Cigarettes per day
STANDARD_DEVIATION 5.35 • n=10 Participants
|
17.8 Cigarettes per day
STANDARD_DEVIATION 5.90 • n=115 Participants
|
17.3 Cigarettes per day
STANDARD_DEVIATION 5.37 • n=6 Participants
|
|
Years Smoked
|
19.4 years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
17.6 years
STANDARD_DEVIATION 11.33 • n=7 Participants
|
18.9 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
23.6 years
STANDARD_DEVIATION 13.68 • n=4 Participants
|
21.7 years
STANDARD_DEVIATION 13.38 • n=21 Participants
|
12.93 years
STANDARD_DEVIATION 12.93 • n=10 Participants
|
22.2 years
STANDARD_DEVIATION 9.36 • n=115 Participants
|
20.8 years
STANDARD_DEVIATION 12.32 • n=6 Participants
|
|
Cigarette Brand Style History Summary
SIGNAL, NON MENTHOL, RED, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Fagerström Test for Cigarette Dependence
|
5.2 points
STANDARD_DEVIATION 2.13 • n=5 Participants
|
5.9 points
STANDARD_DEVIATION 1.76 • n=7 Participants
|
5.4 points
STANDARD_DEVIATION 1.62 • n=5 Participants
|
5.2 points
STANDARD_DEVIATION 1.87 • n=4 Participants
|
5.4 points
STANDARD_DEVIATION 1.43 • n=21 Participants
|
5.6 points
STANDARD_DEVIATION 1.28 • n=10 Participants
|
5.6 points
STANDARD_DEVIATION 1.61 • n=115 Participants
|
5.5 points
STANDARD_DEVIATION 1.62 • n=6 Participants
|
|
Cigarette Brand Style History Summary
NEWPORT, MENTHOL, GREEN, 100mm (100s)
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
65 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NEWPORT, MENTHOL, GREEN, 85mm (Kings)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, GOLD, 85mm (Kings)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, BLACK, 100mm (100s)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, NON MENTHOL, RED, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, RED, 85mm (Kings)
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, NON MENTHOL, BLUE, 100mm (100s)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CAMEL, MENTHOL, CRUSH SILVER, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NATURAL AMERICAN SPIRIT, NON MENTHOL, YELLOW, 85mm (Kings)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CAMEL, MENTHOL, CRUSH, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, MENTHOL, GREEN, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, MENTHOL, GREEN, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
BERLEY, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CAMEL, NON MENTHOL, WIDES FILTERS, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
DECADE, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
KOOL, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, BLACK, 85mm (Kings)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, GOLD, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, MIDNIGHT, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, SMOOTH, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, BLACK, 85mm (Kings)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, RED SPECIAL SELECT, 85mm (Kings)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NEWPORT, NON MENTHOL, RED, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, NON MENTHOL, RED, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
BERLEY, NON MENTHOL, GOLD, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CAMEL, MENTHOL, WIDES DARK GREEN, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CAMEL, NON MENTHOL, BLUE, 85mm (Kings)
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CAMEL, NON MENTHOL, FILTERS, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CAMEL, NON MENTHOL, TURKISH BLEND GOLD, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CHEYENNE, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CHEYENNE, MENTHOL, GREEN, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
CHEYENNE, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
DECADE, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
EAGLE 20'S, MENTHOL, GOLD, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
EDGEFIELD, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
EXETER, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
EXETER, NON MENTHOL, KINGS (RED), 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
EXETER, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, MENTHOL, DARK GREEN (GOLD PACK), 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, MENTHOL, DARK GREEN FILTER, 100mm (100s)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, MENTHOL, DARK GREEN, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, NON MENTHOL, TURKISH BLEND GOLD, 85mm (Kings)
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
LIGGETT, NON MENTHOL, RED, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, GOLD, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, GREEN, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, GREEN, 72mm
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, MENTHOL, NXT, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, BLEND NO 27, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, RED, 72mm
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, SOUTHERN CUT, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, SPECIAL BLEND GOLD, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, SPECIAL BLEND GOLD, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, SPECIAL BLEND RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, SPECIAL BLEND RED, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MAVERICK, MENTHOL, GREEN, 100mm (100s)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NEWPORT, MENTHOL, BLUE, 85mm (Kings)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NEWPORT, MENTHOL, GREEN, 72mm
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NEWPORT, NON MENTHOL, GOLD, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NEWPORT, NON MENTHOL, RED, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, MENTHOL, BLACK, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, MENTHOL, WHITE, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, NON MENTHOL, BLUE, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PALL MALL, NON MENTHOL, RED FILTER, 100mm (100s)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
PYRAMID, NON MENTHOL, RED, 72mm
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
USA GOLD, NON MENTHOL, GOLD, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
WINSTON, NON MENTHOL, GOLD, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
WINSTON, NON MENTHOL, RED, 85mm (Kings)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
L&M, NON MENTHOL, RED FILTER, 85mm (Kings)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
MARLBORO, NON MENTHOL, RED SPECIAL SELECT, 100mm (100s)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Cigarette Brand Style History Summary
NATURAL AMERICAN SPIRIT, NON MENTHOL, TURQUOISE, 85mm (Kings)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT (mITT): All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the lower limit of quantitation (LLOQ) (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
638.849 ng/24 hour
Standard Deviation 309.2360
|
511.889 ng/24 hour
Standard Deviation 273.0646
|
581.676 ng/24 hour
Standard Deviation 317.8968
|
548.751 ng/24 hour
Standard Deviation 259.9637
|
599.162 ng/24 hour
Standard Deviation 387.2946
|
527.260 ng/24 hour
Standard Deviation 208.6977
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
189.353 ng/24 hour
Standard Deviation 109.4009
|
487.095 ng/24 hour
Standard Deviation 276.4866
|
378.601 ng/24 hour
Standard Deviation 225.0280
|
412.952 ng/24 hour
Standard Deviation 252.9450
|
234.376 ng/24 hour
Standard Deviation 183.1248
|
169.303 ng/24 hour
Standard Deviation 77.4737
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
167.289 ng/24 hour
Standard Deviation 100.1691
|
476.074 ng/24 hour
Standard Deviation 296.5802
|
389.094 ng/24 hour
Standard Deviation 226.8891
|
394.254 ng/24 hour
Standard Deviation 240.8056
|
176.869 ng/24 hour
Standard Deviation 135.1699
|
146.405 ng/24 hour
Standard Deviation 60.3849
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-449.496 ng/24 hour
Standard Deviation 257.2221
|
-24.795 ng/24 hour
Standard Deviation 86.2810
|
-203.075 ng/24 hour
Standard Deviation 210.6622
|
-135.800 ng/24 hour
Standard Deviation 143.0520
|
-364.786 ng/24 hour
Standard Deviation 235.7564
|
-357.958 ng/24 hour
Standard Deviation 169.8953
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-460.402 ng/24 hour
Standard Deviation 263.3910
|
-35.816 ng/24 hour
Standard Deviation 85.0846
|
-173.010 ng/24 hour
Standard Deviation 172.5258
|
-154.497 ng/24 hour
Standard Deviation 120.7393
|
-407.814 ng/24 hour
Standard Deviation 259.3657
|
-371.172 ng/24 hour
Standard Deviation 162.2706
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.00 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-66.540 percentage of change
Standard Deviation 18.5833
|
-4.241 percentage of change
Standard Deviation 22.0910
|
-31.755 percentage of change
Standard Deviation 28.5666
|
-26.092 percentage of change
Standard Deviation 23.2887
|
-61.140 percentage of change
Standard Deviation 14.0247
|
-67.092 percentage of change
Standard Deviation 11.7400
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-70.823 percentage of change
Standard Deviation 13.8839
|
-8.377 percentage of change
Standard Deviation 20.0357
|
-29.261 percentage of change
Standard Deviation 20.2229
|
-29.854 percentage of change
Standard Deviation 17.7150
|
-68.763 percentage of change
Standard Deviation 16.4492
|
-71.244 percentage of change
Standard Deviation 8.1469
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of N-nitrosonornicotine (NNN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
37.567 ng/24 hour
Standard Deviation 93.0133
|
17.153 ng/24 hour
Standard Deviation 14.5452
|
25.737 ng/24 hour
Standard Deviation 32.2433
|
20.254 ng/24 hour
Standard Deviation 12.7633
|
21.096 ng/24 hour
Standard Deviation 17.4601
|
20.271 ng/24 hour
Standard Deviation 15.2179
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
1.524 ng/24 hour
Standard Deviation 1.8065
|
15.718 ng/24 hour
Standard Deviation 12.1674
|
14.414 ng/24 hour
Standard Deviation 23.0907
|
13.367 ng/24 hour
Standard Deviation 20.6899
|
5.535 ng/24 hour
Standard Deviation 23.7712
|
0.968 ng/24 hour
Standard Deviation 0.7968
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
0.902 ng/24 hour
Standard Deviation 1.3344
|
16.221 ng/24 hour
Standard Deviation 11.7555
|
34.944 ng/24 hour
Standard Deviation 142.4443
|
26.542 ng/24 hour
Standard Deviation 94.8042
|
1.876 ng/24 hour
Standard Deviation 3.8928
|
1.166 ng/24 hour
Standard Deviation 1.5528
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-36.042 ng/24 hour
Standard Deviation 92.0468
|
-1.434 ng/24 hour
Standard Deviation 6.2770
|
-11.324 ng/24 hour
Standard Deviation 20.7146
|
-6.888 ng/24 hour
Standard Deviation 21.1344
|
-15.562 ng/24 hour
Standard Deviation 27.2973
|
-19.303 ng/24 hour
Standard Deviation 15.2298
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-37.431 ng/24 hour
Standard Deviation 94.9572
|
-0.932 ng/24 hour
Standard Deviation 7.8298
|
9.323 ng/24 hour
Standard Deviation 143.0700
|
6.288 ng/24 hour
Standard Deviation 95.6402
|
-18.669 ng/24 hour
Standard Deviation 16.6816
|
-19.532 ng/24 hour
Standard Deviation 15.8782
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of N-nitrosonornicotine (NNN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.500 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-90.367 percentage of change
Standard Deviation 14.4687
|
17.679 percentage of change
Standard Deviation 135.9950
|
-39.207 percentage of change
Standard Deviation 55.1440
|
-29.116 percentage of change
Standard Deviation 121.2696
|
-79.576 percentage of change
Standard Deviation 68.3202
|
-89.967 percentage of change
Standard Deviation 21.7083
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-93.379 percentage of change
Standard Deviation 11.0686
|
11.041 percentage of change
Standard Deviation 67.8187
|
39.909 percentage of change
Standard Deviation 533.3498
|
110.644 percentage of change
Standard Deviation 699.0961
|
-88.301 percentage of change
Standard Deviation 16.9805
|
-73.064 percentage of change
Standard Deviation 101.7367
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of nicotine equivalents amount excreted (mg/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
15.991 mg/24 hour
Standard Deviation 5.8914
|
16.887 mg/24 hour
Standard Deviation 5.4959
|
17.497 mg/24 hour
Standard Deviation 5.9794
|
17.904 mg/24 hour
Standard Deviation 7.1881
|
15.752 mg/24 hour
Standard Deviation 4.9830
|
16.279 mg/24 hour
Standard Deviation 4.9702
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
5.459 mg/24 hour
Standard Deviation 6.7089
|
16.297 mg/24 hour
Standard Deviation 5.4573
|
12.330 mg/24 hour
Standard Deviation 4.0796
|
15.024 mg/24 hour
Standard Deviation 5.5730
|
8.191 mg/24 hour
Standard Deviation 5.9189
|
0.668 mg/24 hour
Standard Deviation 0.3787
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
5.476 mg/24 hour
Standard Deviation 7.3802
|
16.832 mg/24 hour
Standard Deviation 5.8963
|
12.832 mg/24 hour
Standard Deviation 4.1984
|
15.363 mg/24 hour
Standard Deviation 6.1114
|
7.437 mg/24 hour
Standard Deviation 5.1587
|
0.481 mg/24 hour
Standard Deviation 0.2954
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-10.532 mg/24 hour
Standard Deviation 6.5032
|
-0.590 mg/24 hour
Standard Deviation 3.3816
|
-5.167 mg/24 hour
Standard Deviation 4.8936
|
-2.880 mg/24 hour
Standard Deviation 4.7547
|
-7.561 mg/24 hour
Standard Deviation 6.9238
|
-15.611 mg/24 hour
Standard Deviation 4.8231
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-10.571 mg/24 hour
Standard Deviation 7.2563
|
-0.055 mg/24 hour
Standard Deviation 3.6896
|
-4.429 mg/24 hour
Standard Deviation 3.9681
|
-2.541 mg/24 hour
Standard Deviation 4.6321
|
-8.555 mg/24 hour
Standard Deviation 6.1938
|
-15.580 mg/24 hour
Standard Deviation 4.8301
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of nicotine equivalents amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) for each metabolite were set to one-half of the LLOQ for the calculation of nicotine equivalents. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Nicotine equivalents (mg/g creatinine) = nicotine equivalents (μg/mL) x 100 / creatinine (mg/dL) % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-67.749 percentage of change
Standard Deviation 33.9247
|
-1.783 percentage of change
Standard Deviation 20.5643
|
-25.070 percentage of change
Standard Deviation 23.9100
|
-13.053 percentage of change
Standard Deviation 18.9294
|
-45.240 percentage of change
Standard Deviation 41.5952
|
-95.808 percentage of change
Standard Deviation 1.9997
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-68.537 percentage of change
Standard Deviation 37.0327
|
0.870 percentage of change
Standard Deviation 21.7462
|
-22.036 percentage of change
Standard Deviation 22.1901
|
-11.641 percentage of change
Standard Deviation 21.2360
|
-51.521 percentage of change
Standard Deviation 35.9795
|
-96.968 percentage of change
Standard Deviation 1.4462
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-aminonaphthalene (2-AN) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
2.757 ng/24 hour
Standard Deviation 2.6274
|
35.786 ng/24 hour
Standard Deviation 16.7327
|
20.031 ng/24 hour
Standard Deviation 8.1023
|
20.709 ng/24 hour
Standard Deviation 10.3490
|
1.777 ng/24 hour
Standard Deviation 0.8171
|
2.849 ng/24 hour
Standard Deviation 2.2411
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
36.900 ng/24 hour
Standard Deviation 18.4031
|
35.058 ng/24 hour
Standard Deviation 14.7440
|
38.438 ng/24 hour
Standard Deviation 16.5800
|
39.133 ng/24 hour
Standard Deviation 20.5915
|
35.420 ng/24 hour
Standard Deviation 13.9413
|
39.841 ng/24 hour
Standard Deviation 17.9932
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
2.760 ng/24 hour
Standard Deviation 1.6132
|
33.753 ng/24 hour
Standard Deviation 13.9940
|
21.422 ng/24 hour
Standard Deviation 13.0808
|
21.325 ng/24 hour
Standard Deviation 9.9158
|
2.085 ng/24 hour
Standard Deviation 1.0846
|
2.410 ng/24 hour
Standard Deviation 1.2299
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-34.140 ng/24 hour
Standard Deviation 18.8337
|
-1.304 ng/24 hour
Standard Deviation 8.4746
|
-17.016 ng/24 hour
Standard Deviation 15.3994
|
-17.808 ng/24 hour
Standard Deviation 19.0237
|
-33.335 ng/24 hour
Standard Deviation 13.4748
|
-37.431 ng/24 hour
Standard Deviation 18.0022
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-33.896 ng/24 hour
Standard Deviation 19.2124
|
0.728 ng/24 hour
Standard Deviation 10.3513
|
-18.505 ng/24 hour
Standard Deviation 13.1224
|
-18.424 ng/24 hour
Standard Deviation 17.5363
|
-33.997 ng/24 hour
Standard Deviation 13.1827
|
-36.606 ng/24 hour
Standard Deviation 17.8281
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-aminonaphthalene (2-AN) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.7 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-90.186 percentage of change
Standard Deviation 8.2459
|
-0.214 percentage of change
Standard Deviation 26.2880
|
-41.725 percentage of change
Standard Deviation 34.1635
|
-29.316 percentage of change
Standard Deviation 83.0987
|
-93.792 percentage of change
Standard Deviation 2.8305
|
-93.291 percentage of change
Standard Deviation 3.3952
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-90.671 percentage of change
Standard Deviation 9.5679
|
4.815 percentage of change
Standard Deviation 36.9328
|
-44.657 percentage of change
Standard Deviation 15.4429
|
-39.152 percentage of change
Standard Deviation 34.9209
|
-94.813 percentage of change
Standard Deviation 1.9651
|
-92.289 percentage of change
Standard Deviation 5.3199
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 4-aminobiphenyl (4-ABP) amount excreted (ng/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
25.848 ng/24 hour
Standard Deviation 11.3291
|
23.544 ng/24 hour
Standard Deviation 7.4856
|
27.465 ng/24 hour
Standard Deviation 11.1330
|
26.519 ng/24 hour
Standard Deviation 9.2829
|
24.833 ng/24 hour
Standard Deviation 8.8138
|
26.229 ng/24 hour
Standard Deviation 7.3619
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
3.785 ng/24 hour
Standard Deviation 1.8918
|
21.449 ng/24 hour
Standard Deviation 8.2875
|
15.684 ng/24 hour
Standard Deviation 9.7048
|
16.673 ng/24 hour
Standard Deviation 6.8533
|
3.692 ng/24 hour
Standard Deviation 1.5741
|
3.826 ng/24 hour
Standard Deviation 2.0856
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
3.484 ng/24 hour
Standard Deviation 1.7674
|
21.700 ng/24 hour
Standard Deviation 8.5794
|
14.315 ng/24 hour
Standard Deviation 4.8816
|
15.567 ng/24 hour
Standard Deviation 6.1982
|
3.422 ng/24 hour
Standard Deviation 1.2121
|
3.577 ng/24 hour
Standard Deviation 1.2299
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-22.063 ng/24 hour
Standard Deviation 11.0772
|
-2.095 ng/24 hour
Standard Deviation 5.7359
|
-11.782 ng/24 hour
Standard Deviation 10.5603
|
-9.846 ng/24 hour
Standard Deviation 7.3757
|
-21.140 ng/24 hour
Standard Deviation 7.9655
|
-22.403 ng/24 hour
Standard Deviation 7.0583
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-22.223 ng/24 hour
Standard Deviation 11.3969
|
-1.845 ng/24 hour
Standard Deviation 6.5921
|
-13.155 ng/24 hour
Standard Deviation 7.7979
|
-10.951 ng/24 hour
Standard Deviation 7.0304
|
-21.704 ng/24 hour
Standard Deviation 8.2641
|
-22.419 ng/24 hour
Standard Deviation 7.2026
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 4-aminobiphenyl (4-ABP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1.5 pg/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-83.203 percentage of change
Standard Deviation 9.1553
|
-7.609 percentage of change
Standard Deviation 26.3983
|
-40.399 percentage of change
Standard Deviation 31.8530
|
-34.438 percentage of change
Standard Deviation 20.0016
|
-84.690 percentage of change
Standard Deviation 6.4161
|
-84.782 percentage of change
Standard Deviation 8.1574
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-84.141 percentage of change
Standard Deviation 9.2230
|
-5.403 percentage of change
Standard Deviation 40.5212
|
-44.837 percentage of change
Standard Deviation 13.1354
|
-38.874 percentage of change
Standard Deviation 19.1985
|
-85.226 percentage of change
Standard Deviation 5.6972
|
-85.492 percentage of change
Standard Deviation 6.0029
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
17.668 ug/24 hour
Standard Deviation 15.0939
|
13.637 ug/24 hour
Standard Deviation 6.7273
|
17.845 ug/24 hour
Standard Deviation 12.7203
|
15.730 ug/24 hour
Standard Deviation 12.9229
|
20.015 ug/24 hour
Standard Deviation 12.5156
|
17.608 ug/24 hour
Standard Deviation 12.9125
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
8.768 ug/24 hour
Standard Deviation 6.5494
|
11.473 ug/24 hour
Standard Deviation 6.2511
|
12.822 ug/24 hour
Standard Deviation 9.6015
|
10.819 ug/24 hour
Standard Deviation 6.9893
|
11.119 ug/24 hour
Standard Deviation 6.9600
|
8.115 ug/24 hour
Standard Deviation 5.1282
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
8.393 ug/24 hour
Standard Deviation 6.3959
|
11.316 ug/24 hour
Standard Deviation 5.6391
|
12.475 ug/24 hour
Standard Deviation 8.8931
|
10.571 ug/24 hour
Standard Deviation 6.4028
|
10.289 ug/24 hour
Standard Deviation 5.6391
|
9.284 ug/24 hour
Standard Deviation 7.0913
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-8.900 ug/24 hour
Standard Deviation 12.5444
|
-2.165 ug/24 hour
Standard Deviation 4.4766
|
-5.023 ug/24 hour
Standard Deviation 6.7570
|
-4.910 ug/24 hour
Standard Deviation 7.9708
|
-8.897 ug/24 hour
Standard Deviation 9.5751
|
-9.493 ug/24 hour
Standard Deviation 9.9659
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-9.383 ug/24 hour
Standard Deviation 12.2677
|
-2.322 ug/24 hour
Standard Deviation 4.9621
|
-5.806 ug/24 hour
Standard Deviation 7.8918
|
-5.158 ug/24 hour
Standard Deviation 8.3038
|
-9.865 ug/24 hour
Standard Deviation 10.8247
|
-8.385 ug/24 hour
Standard Deviation 10.4569
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-hydroxyethyl mercapturic acid (HEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.2 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-39.163 percentage of change
Standard Deviation 28.8018
|
-9.584 percentage of change
Standard Deviation 33.1121
|
-22.916 percentage of change
Standard Deviation 29.9492
|
-21.244 percentage of change
Standard Deviation 28.9372
|
-37.608 percentage of change
Standard Deviation 30.2394
|
-48.200 percentage of change
Standard Deviation 21.7805
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-43.496 percentage of change
Standard Deviation 27.6577
|
-8.742 percentage of change
Standard Deviation 37.0142
|
-26.992 percentage of change
Standard Deviation 30.6250
|
-21.940 percentage of change
Standard Deviation 27.9936
|
-37.026 percentage of change
Standard Deviation 42.9784
|
-40.293 percentage of change
Standard Deviation 31.7717
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
265.581 ug/24 hour
Standard Deviation 136.7904
|
252.743 ug/24 hour
Standard Deviation 95.7493
|
262.505 ug/24 hour
Standard Deviation 105.5709
|
283.673 ug/24 hour
Standard Deviation 126.9412
|
255.488 ug/24 hour
Standard Deviation 89.9874
|
255.411 ug/24 hour
Standard Deviation 88.5824
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
36.060 ug/24 hour
Standard Deviation 18.6284
|
235.071 ug/24 hour
Standard Deviation 83.9199
|
156.653 ug/24 hour
Standard Deviation 67.8784
|
169.389 ug/24 hour
Standard Deviation 75.8871
|
37.816 ug/24 hour
Standard Deviation 16.3173
|
36.648 ug/24 hour
Standard Deviation 17.0519
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
34.356 ug/24 hour
Standard Deviation 24.5937
|
242.647 ug/24 hour
Standard Deviation 100.2513
|
162.257 ug/24 hour
Standard Deviation 75.7299
|
169.996 ug/24 hour
Standard Deviation 77.5677
|
33.700 ug/24 hour
Standard Deviation 14.6351
|
35.135 ug/24 hour
Standard Deviation 16.9140
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-229.521 ug/24 hour
Standard Deviation 123.5594
|
-17.672 ug/24 hour
Standard Deviation 59.2731
|
-105.852 ug/24 hour
Standard Deviation 61.4166
|
-114.284 ug/24 hour
Standard Deviation 90.2413
|
-217.672 ug/24 hour
Standard Deviation 78.9090
|
-218.763 ug/24 hour
Standard Deviation 82.4287
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-231.814 ug/24 hour
Standard Deviation 130.7230
|
-10.097 ug/24 hour
Standard Deviation 61.2663
|
-99.937 ug/24 hour
Standard Deviation 66.7027
|
-113.677 ug/24 hour
Standard Deviation 83.6432
|
-222.204 ug/24 hour
Standard Deviation 82.1047
|
-216.801 ug/24 hour
Standard Deviation 79.5800
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-cyanoethylmercapturic acid (CEMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-85.459 percentage of change
Standard Deviation 5.5487
|
-1.763 percentage of change
Standard Deviation 32.1658
|
-39.043 percentage of change
Standard Deviation 15.6110
|
-37.945 percentage of change
Standard Deviation 16.1205
|
-85.106 percentage of change
Standard Deviation 4.6221
|
-84.942 percentage of change
Standard Deviation 6.4947
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-86.194 percentage of change
Standard Deviation 10.0102
|
-0.027 percentage of change
Standard Deviation 35.0628
|
-37.125 percentage of change
Standard Deviation 15.0814
|
-38.185 percentage of change
Standard Deviation 15.7489
|
-86.538 percentage of change
Standard Deviation 3.8480
|
-85.900 percentage of change
Standard Deviation 5.1478
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of S-phenyl mercapturic acid (S-PMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
8.540 ug/24 hour
Standard Deviation 5.0936
|
6.961 ug/24 hour
Standard Deviation 3.8113
|
8.075 ug/24 hour
Standard Deviation 5.6048
|
9.077 ug/24 hour
Standard Deviation 5.8678
|
6.542 ug/24 hour
Standard Deviation 3.7377
|
6.756 ug/24 hour
Standard Deviation 5.0746
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
0.557 ug/24 hour
Standard Deviation 0.5157
|
6.935 ug/24 hour
Standard Deviation 3.7971
|
4.792 ug/24 hour
Standard Deviation 3.4372
|
5.559 ug/24 hour
Standard Deviation 3.9536
|
0.377 ug/24 hour
Standard Deviation 0.1812
|
0.511 ug/24 hour
Standard Deviation 0.3146
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
0.482 ug/24 hour
Standard Deviation 0.4835
|
6.808 ug/24 hour
Standard Deviation 3.6133
|
4.820 ug/24 hour
Standard Deviation 3.0674
|
5.358 ug/24 hour
Standard Deviation 3.7852
|
0.319 ug/24 hour
Standard Deviation 0.1300
|
0.458 ug/24 hour
Standard Deviation 0.2561
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-7.984 ug/24 hour
Standard Deviation 4.9245
|
-0.026 ug/24 hour
Standard Deviation 1.8063
|
-3.283 ug/24 hour
Standard Deviation 2.7294
|
-3.518 ug/24 hour
Standard Deviation 4.0242
|
-6.165 ug/24 hour
Standard Deviation 3.6217
|
-6.246 ug/24 hour
Standard Deviation 4.8651
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-7.948 ug/24 hour
Standard Deviation 5.0623
|
-0.153 ug/24 hour
Standard Deviation 2.0043
|
-3.379 ug/24 hour
Standard Deviation 3.1614
|
-3.719 ug/24 hour
Standard Deviation 3.6616
|
-6.382 ug/24 hour
Standard Deviation 3.6273
|
-6.239 ug/24 hour
Standard Deviation 4.9976
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of S-phenyl mercapturic acid (S-PMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.02 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-92.361 percentage of change
Standard Deviation 5.6169
|
0.414 percentage of change
Standard Deviation 27.7146
|
-39.223 percentage of change
Standard Deviation 16.7927
|
-32.680 percentage of change
Standard Deviation 44.7678
|
-92.666 percentage of change
Standard Deviation 5.5760
|
-89.785 percentage of change
Standard Deviation 7.9606
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-92.651 percentage of change
Standard Deviation 7.7763
|
-0.440 percentage of change
Standard Deviation 27.6623
|
-37.688 percentage of change
Standard Deviation 15.2518
|
-36.710 percentage of change
Standard Deviation 33.5234
|
-93.659 percentage of change
Standard Deviation 5.2551
|
-90.037 percentage of change
Standard Deviation 8.0553
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
606.423 ug/24 hour
Standard Deviation 388.1189
|
550.337 ug/24 hour
Standard Deviation 205.3039
|
566.207 ug/24 hour
Standard Deviation 212.2527
|
620.251 ug/24 hour
Standard Deviation 282.7648
|
569.736 ug/24 hour
Standard Deviation 236.5974
|
563.298 ug/24 hour
Standard Deviation 237.6972
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
167.136 ug/24 hour
Standard Deviation 103.8973
|
508.316 ug/24 hour
Standard Deviation 206.5741
|
354.525 ug/24 hour
Standard Deviation 133.4293
|
404.976 ug/24 hour
Standard Deviation 183.1641
|
144.751 ug/24 hour
Standard Deviation 65.9291
|
141.885 ug/24 hour
Standard Deviation 80.2953
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
150.400 ug/24 hour
Standard Deviation 63.8041
|
521.141 ug/24 hour
Standard Deviation 217.2385
|
368.736 ug/24 hour
Standard Deviation 160.2715
|
383.715 ug/24 hour
Standard Deviation 158.6928
|
157.595 ug/24 hour
Standard Deviation 79.8494
|
155.132 ug/24 hour
Standard Deviation 75.3979
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-439.287 ug/24 hour
Standard Deviation 355.2849
|
-42.021 ug/24 hour
Standard Deviation 124.9105
|
-211.682 ug/24 hour
Standard Deviation 131.0495
|
-215.275 ug/24 hour
Standard Deviation 189.0406
|
-424.984 ug/24 hour
Standard Deviation 215.2851
|
-421.414 ug/24 hour
Standard Deviation 213.6181
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-455.759 ug/24 hour
Standard Deviation 392.8206
|
-29.196 ug/24 hour
Standard Deviation 131.9289
|
-193.629 ug/24 hour
Standard Deviation 132.1995
|
-236.535 ug/24 hour
Standard Deviation 185.1107
|
-414.706 ug/24 hour
Standard Deviation 229.5738
|
-411.417 ug/24 hour
Standard Deviation 194.8371
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-68.831 percentage of change
Standard Deviation 18.5627
|
-5.743 percentage of change
Standard Deviation 22.6960
|
-35.546 percentage of change
Standard Deviation 13.9889
|
-32.157 percentage of change
Standard Deviation 17.5366
|
-72.980 percentage of change
Standard Deviation 12.2613
|
-73.991 percentage of change
Standard Deviation 12.7785
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-68.732 percentage of change
Standard Deviation 19.6288
|
-3.562 percentage of change
Standard Deviation 25.6505
|
-33.002 percentage of change
Standard Deviation 17.2920
|
-35.002 percentage of change
Standard Deviation 15.4967
|
-70.424 percentage of change
Standard Deviation 15.9381
|
-72.466 percentage of change
Standard Deviation 9.0818
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
1865.738 ug/24 hour
Standard Deviation 901.8706
|
1743.226 ug/24 hour
Standard Deviation 668.1382
|
1766.765 ug/24 hour
Standard Deviation 615.6747
|
1986.391 ug/24 hour
Standard Deviation 853.8727
|
1811.893 ug/24 hour
Standard Deviation 878.2589
|
1922.765 ug/24 hour
Standard Deviation 697.3324
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
433.971 ug/24 hour
Standard Deviation 295.7202
|
1677.258 ug/24 hour
Standard Deviation 665.1729
|
1043.324 ug/24 hour
Standard Deviation 409.5555
|
1201.051 ug/24 hour
Standard Deviation 542.2406
|
460.103 ug/24 hour
Standard Deviation 391.5957
|
471.823 ug/24 hour
Standard Deviation 210.0711
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
384.725 ug/24 hour
Standard Deviation 186.4687
|
1658.754 ug/24 hour
Standard Deviation 609.9999
|
1047.861 ug/24 hour
Standard Deviation 369.5717
|
1152.712 ug/24 hour
Standard Deviation 512.4255
|
414.764 ug/24 hour
Standard Deviation 193.2655
|
465.606 ug/24 hour
Standard Deviation 181.1420
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-1431.767 ug/24 hour
Standard Deviation 841.9879
|
-65.969 ug/24 hour
Standard Deviation 393.3398
|
-723.442 ug/24 hour
Standard Deviation 409.5358
|
-785.340 ug/24 hour
Standard Deviation 505.9671
|
-1351.790 ug/24 hour
Standard Deviation 761.5792
|
-1450.942 ug/24 hour
Standard Deviation 571.8160
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-1485.874 ug/24 hour
Standard Deviation 894.8234
|
-84.472 ug/24 hour
Standard Deviation 405.0119
|
-715.263 ug/24 hour
Standard Deviation 368.4390
|
-833.680 ug/24 hour
Standard Deviation 621.2865
|
-1442.549 ug/24 hour
Standard Deviation 862.2948
|
-1455.899 ug/24 hour
Standard Deviation 646.1344
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (25 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-75.303 percentage of change
Standard Deviation 13.2868
|
-1.420 percentage of change
Standard Deviation 24.6382
|
-39.382 percentage of change
Standard Deviation 16.8251
|
-37.881 percentage of change
Standard Deviation 14.6021
|
-74.412 percentage of change
Standard Deviation 14.4248
|
-74.897 percentage of change
Standard Deviation 7.6082
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-76.922 percentage of change
Standard Deviation 13.0070
|
-1.110 percentage of change
Standard Deviation 25.6542
|
-39.328 percentage of change
Standard Deviation 10.6349
|
-39.461 percentage of change
Standard Deviation 16.1768
|
-74.522 percentage of change
Standard Deviation 13.5851
|
-74.238 percentage of change
Standard Deviation 9.0407
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
116.041 ug/24 hour
Standard Deviation 64.3856
|
105.297 ug/24 hour
Standard Deviation 54.5963
|
110.378 ug/24 hour
Standard Deviation 62.4698
|
113.258 ug/24 hour
Standard Deviation 64.2108
|
108.420 ug/24 hour
Standard Deviation 63.0178
|
115.231 ug/24 hour
Standard Deviation 54.4428
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
21.284 ug/24 hour
Standard Deviation 7.7785
|
106.168 ug/24 hour
Standard Deviation 59.9458
|
73.687 ug/24 hour
Standard Deviation 45.6677
|
73.431 ug/24 hour
Standard Deviation 32.8976
|
36.173 ug/24 hour
Standard Deviation 40.3089
|
23.226 ug/24 hour
Standard Deviation 7.9556
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
22.004 ug/24 hour
Standard Deviation 9.4428
|
100.714 ug/24 hour
Standard Deviation 51.4490
|
72.440 ug/24 hour
Standard Deviation 39.9138
|
70.583 ug/24 hour
Standard Deviation 31.1338
|
33.002 ug/24 hour
Standard Deviation 18.4874
|
26.843 ug/24 hour
Standard Deviation 9.3874
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-94.758 ug/24 hour
Standard Deviation 63.0836
|
0.871 ug/24 hour
Standard Deviation 34.9551
|
-36.691 ug/24 hour
Standard Deviation 33.3048
|
-39.827 ug/24 hour
Standard Deviation 47.7576
|
-72.247 ug/24 hour
Standard Deviation 71.8521
|
-92.006 ug/24 hour
Standard Deviation 53.5034
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-93.636 ug/24 hour
Standard Deviation 65.3517
|
-4.583 ug/24 hour
Standard Deviation 21.8338
|
-39.574 ug/24 hour
Standard Deviation 33.6340
|
-42.675 ug/24 hour
Standard Deviation 52.2138
|
-77.317 ug/24 hour
Standard Deviation 65.6904
|
-89.342 ug/24 hour
Standard Deviation 53.0876
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-hydroxypropyl-mercapturic acid (2-HPMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (2.5 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-73.489 percentage of change
Standard Deviation 21.9780
|
2.576 percentage of change
Standard Deviation 35.0793
|
-30.260 percentage of change
Standard Deviation 22.7811
|
-28.992 percentage of change
Standard Deviation 20.1727
|
-59.835 percentage of change
Standard Deviation 42.1367
|
-75.225 percentage of change
Standard Deviation 16.1842
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-72.078 percentage of change
Standard Deviation 24.0289
|
-1.857 percentage of change
Standard Deviation 20.6712
|
-32.286 percentage of change
Standard Deviation 15.7228
|
-30.611 percentage of change
Standard Deviation 19.9059
|
-61.684 percentage of change
Standard Deviation 33.6407
|
-71.565 percentage of change
Standard Deviation 20.1576
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
179.355 ug/24 hour
Standard Deviation 60.6867
|
205.752 ug/24 hour
Standard Deviation 69.9796
|
213.840 ug/24 hour
Standard Deviation 84.3383
|
234.379 ug/24 hour
Standard Deviation 110.9685
|
203.156 ug/24 hour
Standard Deviation 69.9106
|
212.299 ug/24 hour
Standard Deviation 72.6566
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
85.598 ug/24 hour
Standard Deviation 53.8351
|
196.301 ug/24 hour
Standard Deviation 78.9983
|
162.085 ug/24 hour
Standard Deviation 77.9669
|
185.991 ug/24 hour
Standard Deviation 85.8673
|
84.941 ug/24 hour
Standard Deviation 36.0825
|
112.082 ug/24 hour
Standard Deviation 48.2731
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
99.589 ug/24 hour
Standard Deviation 70.9683
|
209.546 ug/24 hour
Standard Deviation 92.1646
|
170.626 ug/24 hour
Standard Deviation 87.7149
|
194.963 ug/24 hour
Standard Deviation 78.8241
|
91.040 ug/24 hour
Standard Deviation 46.5105
|
103.427 ug/24 hour
Standard Deviation 61.1171
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-79.766 ug/24 hour
Standard Deviation 73.7312
|
3.794 ug/24 hour
Standard Deviation 61.0286
|
-43.214 ug/24 hour
Standard Deviation 47.8198
|
-39.416 ug/24 hour
Standard Deviation 74.9528
|
-112.116 ug/24 hour
Standard Deviation 61.2701
|
-108.872 ug/24 hour
Standard Deviation 60.5423
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-96.049 ug/24 hour
Standard Deviation 49.6356
|
-9.451 ug/24 hour
Standard Deviation 47.6276
|
-53.542 ug/24 hour
Standard Deviation 45.4159
|
-48.387 ug/24 hour
Standard Deviation 69.3531
|
-122.821 ug/24 hour
Standard Deviation 56.8629
|
-96.887 ug/24 hour
Standard Deviation 57.5065
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original Values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-43.579 percentage of change
Standard Deviation 35.6609
|
2.922 percentage of change
Standard Deviation 27.1486
|
-20.973 percentage of change
Standard Deviation 22.5861
|
-11.986 percentage of change
Standard Deviation 25.3885
|
-53.493 percentage of change
Standard Deviation 21.2336
|
-51.247 percentage of change
Standard Deviation 20.0931
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-53.682 percentage of change
Standard Deviation 18.2362
|
-3.571 percentage of change
Standard Deviation 22.7243
|
-25.039 percentage of change
Standard Deviation 17.9283
|
-17.088 percentage of change
Standard Deviation 22.3929
|
-57.436 percentage of change
Standard Deviation 15.7971
|
-45.335 percentage of change
Standard Deviation 20.0234
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
25.403 ug/24 hour
Standard Deviation 7.9934
|
28.151 ug/24 hour
Standard Deviation 7.9362
|
30.337 ug/24 hour
Standard Deviation 9.1426
|
30.415 ug/24 hour
Standard Deviation 12.2998
|
26.270 ug/24 hour
Standard Deviation 9.0014
|
30.737 ug/24 hour
Standard Deviation 10.1313
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
15.898 ug/24 hour
Standard Deviation 6.4032
|
28.123 ug/24 hour
Standard Deviation 9.0482
|
24.988 ug/24 hour
Standard Deviation 8.6134
|
26.343 ug/24 hour
Standard Deviation 9.3111
|
15.080 ug/24 hour
Standard Deviation 5.3359
|
17.982 ug/24 hour
Standard Deviation 8.1223
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
14.184 ug/24 hour
Standard Deviation 6.1136
|
27.310 ug/24 hour
Standard Deviation 8.8508
|
24.808 ug/24 hour
Standard Deviation 9.1001
|
25.701 ug/24 hour
Standard Deviation 9.1838
|
14.272 ug/24 hour
Standard Deviation 5.0565
|
18.856 ug/24 hour
Standard Deviation 6.6119
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-9.504 ug/24 hour
Standard Deviation 8.2824
|
-0.029 ug/24 hour
Standard Deviation 6.6123
|
-5.349 ug/24 hour
Standard Deviation 6.0495
|
-4.072 ug/24 hour
Standard Deviation 8.5389
|
-11.190 ug/24 hour
Standard Deviation 7.8064
|
-12.754 ug/24 hour
Standard Deviation 7.9808
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-11.525 ug/24 hour
Standard Deviation 7.7630
|
-0.842 ug/24 hour
Standard Deviation 5.6395
|
-5.562 ug/24 hour
Standard Deviation 5.0722
|
-4.714 ug/24 hour
Standard Deviation 8.9415
|
-12.681 ug/24 hour
Standard Deviation 7.5912
|
-11.638 ug/24 hour
Standard Deviation 7.8765
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine (GAMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-43.200 percentage of change
Standard Deviation 19.3353
|
-1.515 percentage of change
Standard Deviation 21.1321
|
-18.456 percentage of change
Standard Deviation 16.3993
|
-11.236 percentage of change
Standard Deviation 24.0586
|
-44.682 percentage of change
Standard Deviation 19.3080
|
-36.587 percentage of change
Standard Deviation 16.0285
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-34.427 percentage of change
Standard Deviation 25.2883
|
2.015 percentage of change
Standard Deviation 23.0063
|
-16.449 percentage of change
Standard Deviation 19.0682
|
-9.361 percentage of change
Standard Deviation 23.0900
|
-39.251 percentage of change
Standard Deviation 22.4238
|
-40.803 percentage of change
Standard Deviation 18.2548
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
5.866 ug/24 hour
Standard Deviation 4.1432
|
5.230 ug/24 hour
Standard Deviation 4.3362
|
6.226 ug/24 hour
Standard Deviation 6.0371
|
7.136 ug/24 hour
Standard Deviation 6.3804
|
4.146 ug/24 hour
Standard Deviation 3.8962
|
5.136 ug/24 hour
Standard Deviation 4.5388
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
0.142 ug/24 hour
Standard Deviation 0.0714
|
5.126 ug/24 hour
Standard Deviation 3.6876
|
3.287 ug/24 hour
Standard Deviation 3.0863
|
3.703 ug/24 hour
Standard Deviation 3.5055
|
0.186 ug/24 hour
Standard Deviation 0.1141
|
0.259 ug/24 hour
Standard Deviation 0.2148
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
0.183 ug/24 hour
Standard Deviation 0.1539
|
5.284 ug/24 hour
Standard Deviation 4.4769
|
3.406 ug/24 hour
Standard Deviation 3.1052
|
4.128 ug/24 hour
Standard Deviation 3.4363
|
0.188 ug/24 hour
Standard Deviation 0.1097
|
0.216 ug/24 hour
Standard Deviation 0.1532
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-5.724 ug/24 hour
Standard Deviation 4.1297
|
-0.104 ug/24 hour
Standard Deviation 1.9552
|
-2.939 ug/24 hour
Standard Deviation 3.4047
|
-3.433 ug/24 hour
Standard Deviation 4.1785
|
-3.960 ug/24 hour
Standard Deviation 3.8836
|
-4.877 ug/24 hour
Standard Deviation 4.5654
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-5.913 ug/24 hour
Standard Deviation 4.0535
|
0.054 ug/24 hour
Standard Deviation 2.3432
|
-2.995 ug/24 hour
Standard Deviation 3.6985
|
-3.008 ug/24 hour
Standard Deviation 4.1064
|
-4.102 ug/24 hour
Standard Deviation 3.9316
|
-4.971 ug/24 hour
Standard Deviation 4.6010
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-hydroxybutenyl-mercapturic acid (2-MHBMA) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.129 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-82.576 percentage of change
Standard Deviation 35.6633
|
89.466 percentage of change
Standard Deviation 362.5275
|
39.458 percentage of change
Standard Deviation 291.2398
|
-3.704 percentage of change
Standard Deviation 164.5239
|
-66.761 percentage of change
Standard Deviation 48.4733
|
-50.591 percentage of change
Standard Deviation 124.5982
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-76.231 percentage of change
Standard Deviation 76.9824
|
97.272 percentage of change
Standard Deviation 337.2550
|
28.617 percentage of change
Standard Deviation 287.5681
|
66.188 percentage of change
Standard Deviation 460.0304
|
-68.019 percentage of change
Standard Deviation 49.9841
|
-72.699 percentage of change
Standard Deviation 48.5745
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-OH-Fluorene (2-OHFLe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=27 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
5.424 ug/24 hour
Standard Deviation 4.1109
|
6.013 ug/24 hour
Standard Deviation 5.5242
|
6.453 ug/24 hour
Standard Deviation 4.1583
|
4.947 ug/24 hour
Standard Deviation 4.2710
|
8.101 ug/24 hour
Standard Deviation 16.9678
|
4.852 ug/24 hour
Standard Deviation 2.3571
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
2.857 ug/24 hour
Standard Deviation 2.6235
|
5.535 ug/24 hour
Standard Deviation 5.5502
|
6.002 ug/24 hour
Standard Deviation 14.2979
|
5.006 ug/24 hour
Standard Deviation 10.0199
|
2.879 ug/24 hour
Standard Deviation 4.0524
|
2.101 ug/24 hour
Standard Deviation 1.2935
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
2.238 ug/24 hour
Standard Deviation 2.5664
|
5.471 ug/24 hour
Standard Deviation 4.9675
|
4.029 ug/24 hour
Standard Deviation 4.2137
|
3.219 ug/24 hour
Standard Deviation 3.6982
|
2.493 ug/24 hour
Standard Deviation 3.5417
|
2.046 ug/24 hour
Standard Deviation 2.1506
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-2.567 ug/24 hour
Standard Deviation 4.2155
|
-0.478 ug/24 hour
Standard Deviation 5.8039
|
-0.452 ug/24 hour
Standard Deviation 15.4210
|
-0.023 ug/24 hour
Standard Deviation 9.1944
|
-5.222 ug/24 hour
Standard Deviation 16.0117
|
-2.752 ug/24 hour
Standard Deviation 2.0610
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-3.176 ug/24 hour
Standard Deviation 4.9330
|
-0.668 ug/24 hour
Standard Deviation 5.3174
|
-2.386 ug/24 hour
Standard Deviation 4.3279
|
-1.728 ug/24 hour
Standard Deviation 3.6338
|
-5.989 ug/24 hour
Standard Deviation 15.2327
|
-2.710 ug/24 hour
Standard Deviation 2.7968
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-OH-Fluorene (2-OHFLe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.1 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=27 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-48.971 percentage of change
Standard Deviation 54.0298
|
15.496 percentage of change
Standard Deviation 81.6064
|
503.991 percentage of change
Standard Deviation 3454.7322
|
272.425 percentage of change
Standard Deviation 1374.3325
|
-63.094 percentage of change
Standard Deviation 41.9257
|
-54.026 percentage of change
Standard Deviation 57.9650
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-45.034 percentage of change
Standard Deviation 38.3930
|
12.958 percentage of change
Standard Deviation 105.7554
|
5043.768 percentage of change
Standard Deviation 32905.9569
|
178.037 percentage of change
Standard Deviation 1045.5731
|
-37.094 percentage of change
Standard Deviation 118.0482
|
-52.455 percentage of change
Standard Deviation 32.2698
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-Naphthol amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
27.688 ug/24 hour
Standard Deviation 12.7029
|
26.351 ug/24 hour
Standard Deviation 13.4453
|
28.168 ug/24 hour
Standard Deviation 9.0786
|
28.246 ug/24 hour
Standard Deviation 12.6762
|
26.292 ug/24 hour
Standard Deviation 8.6468
|
24.827 ug/24 hour
Standard Deviation 9.7689
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
6.559 ug/24 hour
Standard Deviation 3.8649
|
23.047 ug/24 hour
Standard Deviation 9.2844
|
16.141 ug/24 hour
Standard Deviation 7.9059
|
16.385 ug/24 hour
Standard Deviation 5.7688
|
6.407 ug/24 hour
Standard Deviation 5.0282
|
7.299 ug/24 hour
Standard Deviation 8.1699
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
6.670 ug/24 hour
Standard Deviation 4.5266
|
23.191 ug/24 hour
Standard Deviation 8.1002
|
16.228 ug/24 hour
Standard Deviation 8.2504
|
15.475 ug/24 hour
Standard Deviation 7.1820
|
5.436 ug/24 hour
Standard Deviation 4.3673
|
8.216 ug/24 hour
Standard Deviation 8.9779
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-21.129 ug/24 hour
Standard Deviation 12.6944
|
-3.304 ug/24 hour
Standard Deviation 13.7567
|
-12.027 ug/24 hour
Standard Deviation 6.3192
|
-11.860 ug/24 hour
Standard Deviation 11.0884
|
-19.885 ug/24 hour
Standard Deviation 8.2403
|
-17.527 ug/24 hour
Standard Deviation 8.9468
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-20.747 ug/24 hour
Standard Deviation 13.6498
|
-3.160 ug/24 hour
Standard Deviation 13.3625
|
-11.651 ug/24 hour
Standard Deviation 5.1880
|
-12.771 ug/24 hour
Standard Deviation 10.2647
|
-20.326 ug/24 hour
Standard Deviation 9.2076
|
-16.367 ug/24 hour
Standard Deviation 8.8314
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 2-Naphthol amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.10 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-72.375 percentage of change
Standard Deviation 20.2036
|
-2.871 percentage of change
Standard Deviation 48.4874
|
-42.250 percentage of change
Standard Deviation 17.7416
|
-35.217 percentage of change
Standard Deviation 25.6833
|
-74.880 percentage of change
Standard Deviation 16.3832
|
-72.152 percentage of change
Standard Deviation 20.3724
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-70.911 percentage of change
Standard Deviation 23.8688
|
-3.848 percentage of change
Standard Deviation 33.7807
|
-42.498 percentage of change
Standard Deviation 16.2147
|
-40.149 percentage of change
Standard Deviation 24.8026
|
-77.080 percentage of change
Standard Deviation 18.5790
|
-69.892 percentage of change
Standard Deviation 26.9968
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
0.342 ug/24 hour
Standard Deviation 0.1495
|
0.291 ug/24 hour
Standard Deviation 0.1655
|
0.325 ug/24 hour
Standard Deviation 0.1332
|
0.324 ug/24 hour
Standard Deviation 0.1591
|
0.273 ug/24 hour
Standard Deviation 0.1560
|
0.348 ug/24 hour
Standard Deviation 0.1870
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
0.147 ug/24 hour
Standard Deviation 0.1357
|
0.278 ug/24 hour
Standard Deviation 0.1902
|
0.206 ug/24 hour
Standard Deviation 0.1019
|
0.214 ug/24 hour
Standard Deviation 0.0966
|
0.101 ug/24 hour
Standard Deviation 0.0567
|
0.131 ug/24 hour
Standard Deviation 0.0617
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
0.126 ug/24 hour
Standard Deviation 0.0827
|
0.273 ug/24 hour
Standard Deviation 0.1779
|
0.190 ug/24 hour
Standard Deviation 0.0833
|
0.190 ug/24 hour
Standard Deviation 0.1011
|
0.095 ug/24 hour
Standard Deviation 0.0546
|
0.149 ug/24 hour
Standard Deviation 0.0923
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-0.195 ug/24 hour
Standard Deviation 0.2001
|
-0.013 ug/24 hour
Standard Deviation 0.1110
|
-0.119 ug/24 hour
Standard Deviation 0.1104
|
-0.110 ug/24 hour
Standard Deviation 0.1535
|
-0.172 ug/24 hour
Standard Deviation 0.1313
|
-0.217 ug/24 hour
Standard Deviation 0.1672
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-0.209 ug/24 hour
Standard Deviation 0.1597
|
-0.018 ug/24 hour
Standard Deviation 0.1123
|
-0.133 ug/24 hour
Standard Deviation 0.0954
|
-0.134 ug/24 hour
Standard Deviation 0.1253
|
-0.182 ug/24 hour
Standard Deviation 0.1308
|
-0.185 ug/24 hour
Standard Deviation 0.1665
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 1-OH-Phenanthrene (1-OHPhe) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.005 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-47.691 percentage of change
Standard Deviation 44.6728
|
-2.014 percentage of change
Standard Deviation 35.7667
|
-30.659 percentage of change
Standard Deviation 39.1914
|
-21.599 percentage of change
Standard Deviation 45.5212
|
-54.224 percentage of change
Standard Deviation 39.4318
|
-56.563 percentage of change
Standard Deviation 25.0593
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-55.524 percentage of change
Standard Deviation 30.9398
|
-3.193 percentage of change
Standard Deviation 33.2980
|
-35.291 percentage of change
Standard Deviation 32.2576
|
-32.597 percentage of change
Standard Deviation 38.1268
|
-31.699 percentage of change
Standard Deviation 156.6252
|
-52.495 percentage of change
Standard Deviation 28.1468
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 1-hydroxypyrene (1-OHP) amount excreted (ug/24 hour) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day -1
|
0.688 ug/24 hour
Standard Deviation 0.6987
|
0.463 ug/24 hour
Standard Deviation 0.4552
|
0.446 ug/24 hour
Standard Deviation 0.2545
|
0.592 ug/24 hour
Standard Deviation 0.4884
|
0.473 ug/24 hour
Standard Deviation 0.2597
|
0.446 ug/24 hour
Standard Deviation 0.2616
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 5
|
0.407 ug/24 hour
Standard Deviation 0.3324
|
0.428 ug/24 hour
Standard Deviation 0.2850
|
0.380 ug/24 hour
Standard Deviation 0.2917
|
0.454 ug/24 hour
Standard Deviation 0.2575
|
0.338 ug/24 hour
Standard Deviation 0.2872
|
0.314 ug/24 hour
Standard Deviation 0.2238
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Day 7
|
0.483 ug/24 hour
Standard Deviation 0.4287
|
0.377 ug/24 hour
Standard Deviation 0.1970
|
0.352 ug/24 hour
Standard Deviation 0.2555
|
0.451 ug/24 hour
Standard Deviation 0.3757
|
0.371 ug/24 hour
Standard Deviation 0.3406
|
0.440 ug/24 hour
Standard Deviation 0.4277
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-0.281 ug/24 hour
Standard Deviation 0.6769
|
-0.034 ug/24 hour
Standard Deviation 0.4123
|
-0.066 ug/24 hour
Standard Deviation 0.2799
|
-0.138 ug/24 hour
Standard Deviation 0.3833
|
-0.135 ug/24 hour
Standard Deviation 0.3196
|
-0.132 ug/24 hour
Standard Deviation 0.2950
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-0.213 ug/24 hour
Standard Deviation 0.6848
|
-0.085 ug/24 hour
Standard Deviation 0.3795
|
-0.077 ug/24 hour
Standard Deviation 0.2851
|
-0.141 ug/24 hour
Standard Deviation 0.3754
|
-0.094 ug/24 hour
Standard Deviation 0.3427
|
0.010 ug/24 hour
Standard Deviation 0.3450
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of 1-hydroxypyrene (1-OHP) amount excreted percent change from Baseline (%) is presented. Subjects with valid sample results are included. Original values reported as below the limit of quantitation (BLQ) were set to one-half of the LLOQ (0.01 ng/mL) for summarization and statistical analysis. Baseline = Day -1. 24-hour urine collections occurred on Days -1, 5, and 7 beginning after the first morning void and any void prior to 07:00, and finished the following morning with the last void collected at approximately 07:00 (including first morning void). % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=27 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-22.640 percentage of change
Standard Deviation 46.8991
|
14.604 percentage of change
Standard Deviation 64.3632
|
-9.171 percentage of change
Standard Deviation 55.4282
|
-3.632 percentage of change
Standard Deviation 63.0769
|
-19.442 percentage of change
Standard Deviation 63.1149
|
-9.058 percentage of change
Standard Deviation 94.5456
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-18.133 percentage of change
Standard Deviation 51.8440
|
1.713 percentage of change
Standard Deviation 40.2284
|
-9.849 percentage of change
Standard Deviation 58.6387
|
-15.538 percentage of change
Standard Deviation 49.5890
|
-10.328 percentage of change
Standard Deviation 72.1902
|
1.959 percentage of change
Standard Deviation 68.3664
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of urine mutagenicity (revertants/24 hours) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=39 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=40 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=26 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population)
Day 7
|
5231.0 revertants/24 hours
Standard Deviation 6316.63
|
40008.3 revertants/24 hours
Standard Deviation 32211.76
|
21884.6 revertants/24 hours
Standard Deviation 13846.21
|
23575.3 revertants/24 hours
Standard Deviation 16787.62
|
2962.7 revertants/24 hours
Standard Deviation 4112.19
|
4642.7 revertants/24 hours
Standard Deviation 6147.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population)
Day 5
|
3222.7 revertants/24 hours
Standard Deviation 4029.83
|
39814.0 revertants/24 hours
Standard Deviation 33030.58
|
21489.1 revertants/24 hours
Standard Deviation 15437.94
|
18917.1 revertants/24 hours
Standard Deviation 11973.55
|
2450.8 revertants/24 hours
Standard Deviation 3355.41
|
3051.1 revertants/24 hours
Standard Deviation 3011.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population)
Day -1
|
38042.0 revertants/24 hours
Standard Deviation 25874.21
|
42695.9 revertants/24 hours
Standard Deviation 31628.41
|
40627.1 revertants/24 hours
Standard Deviation 24929.42
|
31725.0 revertants/24 hours
Standard Deviation 22029.85
|
39185.5 revertants/24 hours
Standard Deviation 23427.24
|
45475.7 revertants/24 hours
Standard Deviation 24556.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-34819.4 revertants/24 hours
Standard Deviation 24457.34
|
-2881.9 revertants/24 hours
Standard Deviation 19517.06
|
-20856.2 revertants/24 hours
Standard Deviation 22171.89
|
-12807.9 revertants/24 hours
Standard Deviation 16642.34
|
-36734.7 revertants/24 hours
Standard Deviation 22541.48
|
-41002.6 revertants/24 hours
Standard Deviation 24082.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-33209.8 revertants/24 hours
Standard Deviation 25485.69
|
-2687.6 revertants/24 hours
Standard Deviation 24781.58
|
-17841.2 revertants/24 hours
Standard Deviation 21897.40
|
-8149.7 revertants/24 hours
Standard Deviation 14961.88
|
-36626.8 revertants/24 hours
Standard Deviation 25513.32
|
-42147.8 revertants/24 hours
Standard Deviation 23806.81
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of urine mutagenicity percent change from Baseline (%) by study group and study day is presented. Baseline = Day -1. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. The measurement results will be reported as revertants/μL. The urine mutagenicity count in the 24 hour urine will be calculated as: Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x urine volume/ urine sample volume in mL % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=37 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=40 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=23 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-91.239 percentage of change
Standard Deviation 9.0409
|
6.059 percentage of change
Standard Deviation 60.6504
|
-40.200 percentage of change
Standard Deviation 37.5319
|
-27.954 percentage of change
Standard Deviation 45.8289
|
-93.056 percentage of change
Standard Deviation 7.6922
|
-91.057 percentage of change
Standard Deviation 9.3363
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-84.415 percentage of change
Standard Deviation 16.2799
|
7.844 percentage of change
Standard Deviation 62.4696
|
-26.765 percentage of change
Standard Deviation 75.6831
|
-14.729 percentage of change
Standard Deviation 60.1017
|
-87.632 percentage of change
Standard Deviation 25.0981
|
-88.904 percentage of change
Standard Deviation 11.3419
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of whole blood carboxyhemoglobin \[COHb\] (% saturation) by study group on Days -1, 5 and 7, and absolute change from Baseline on Days 5 and 7 are presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. Absolute change from baseline was calculated as: Post Randomization Value - Baseline Value
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population)
Day -1
|
7.23 % Saturation
Standard Deviation 2.269
|
6.68 % Saturation
Standard Deviation 1.815
|
6.81 % Saturation
Standard Deviation 1.650
|
7.11 % Saturation
Standard Deviation 1.927
|
6.98 % Saturation
Standard Deviation 1.711
|
6.89 % Saturation
Standard Deviation 2.038
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population)
Day 5
|
1.78 % Saturation
Standard Deviation 0.169
|
6.53 % Saturation
Standard Deviation 1.599
|
4.50 % Saturation
Standard Deviation 1.216
|
4.91 % Saturation
Standard Deviation 1.304
|
1.73 % Saturation
Standard Deviation 0.272
|
1.79 % Saturation
Standard Deviation 0.281
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population)
Day 7
|
1.85 % Saturation
Standard Deviation 0.302
|
6.77 % Saturation
Standard Deviation 1.516
|
4.61 % Saturation
Standard Deviation 1.244
|
5.11 % Saturation
Standard Deviation 1.274
|
1.82 % Saturation
Standard Deviation 0.388
|
1.79 % Saturation
Standard Deviation 0.281
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 5)
|
-5.45 % Saturation
Standard Deviation 2.253
|
-0.15 % Saturation
Standard Deviation 1.231
|
-2.32 % Saturation
Standard Deviation 1.328
|
-2.20 % Saturation
Standard Deviation 1.251
|
-5.25 % Saturation
Standard Deviation 1.711
|
-5.10 % Saturation
Standard Deviation 1.903
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population)
Change from Baseline (Day 7)
|
-5.28 % Saturation
Standard Deviation 2.269
|
0.09 % Saturation
Standard Deviation 1.394
|
-2.20 % Saturation
Standard Deviation 1.304
|
-1.98 % Saturation
Standard Deviation 1.193
|
-5.22 % Saturation
Standard Deviation 1.684
|
-5.04 % Saturation
Standard Deviation 1.893
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of whole blood carboxyhemoglobin (COHb) percent change from Baseline (%) is presented. Subjects with valid sample results are included. Baseline = Day -1. The blood sample for COHb was collected approximately 21:30 on Days -1, 5, and 7 after subjects abstained from product use, as appropriate, for at least 15 minutes prior to blood draw for COHb. % change from Baseline = (Post Randomization Value - Baseline Value) / Baseline Value x 100 %
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 5
|
-73.352 percentage of change
Standard Deviation 7.5619
|
0.459 percentage of change
Standard Deviation 19.3191
|
-32.762 percentage of change
Standard Deviation 15.6487
|
-29.807 percentage of change
Standard Deviation 11.1205
|
-73.827 percentage of change
Standard Deviation 7.7024
|
-72.424 percentage of change
Standard Deviation 7.7658
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population)
Day 7
|
-71.853 percentage of change
Standard Deviation 10.0793
|
5.451 percentage of change
Standard Deviation 25.3747
|
-31.264 percentage of change
Standard Deviation 14.3934
|
-26.160 percentage of change
Standard Deviation 14.0914
|
-72.896 percentage of change
Standard Deviation 7.7120
|
-72.391 percentage of change
Standard Deviation 6.4588
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1 and Day -2 (Baseline), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Subjects in Groups 4, 5, and 6 were instructed to refrain from smoking cigarettes after Day -1 in compliance with the product use group assignment. No CPD data was collected for these groups on Days 1 through 7 and the Number of Participants Analyzed is reported as '0' in the data table.
Summary of cigarette consumption, as number of cigarettes smoked per day (CPD), by study group and study day is presented. Baseline = Average of Days -2 and -1.
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=41 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=28 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day -2
|
16.7 cigarettes per day
Standard Deviation 4.95
|
16.6 cigarettes per day
Standard Deviation 3.80
|
16.7 cigarettes per day
Standard Deviation 4.15
|
17.8 cigarettes per day
Standard Deviation 4.82
|
16.8 cigarettes per day
Standard Deviation 5.08
|
16.2 cigarettes per day
Standard Deviation 3.68
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day -1
|
17.3 cigarettes per day
Standard Deviation 4.67
|
17.4 cigarettes per day
Standard Deviation 4.52
|
17.6 cigarettes per day
Standard Deviation 4.52
|
18.8 cigarettes per day
Standard Deviation 6.17
|
17.0 cigarettes per day
Standard Deviation 4.73
|
17.5 cigarettes per day
Standard Deviation 4.20
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Baseline
|
17.02 cigarettes per day
Standard Deviation 4.568
|
17.00 cigarettes per day
Standard Deviation 3.958
|
17.17 cigarettes per day
Standard Deviation 4.131
|
18.33 cigarettes per day
Standard Deviation 5.197
|
16.89 cigarettes per day
Standard Deviation 4.661
|
16.82 cigarettes per day
Standard Deviation 3.735
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day 1
|
—
|
16.4 cigarettes per day
Standard Deviation 3.71
|
8.1 cigarettes per day
Standard Deviation 2.14
|
8.8 cigarettes per day
Standard Deviation 2.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day 2
|
—
|
16.0 cigarettes per day
Standard Deviation 3.70
|
8.2 cigarettes per day
Standard Deviation 2.35
|
8.7 cigarettes per day
Standard Deviation 2.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day 3
|
—
|
15.7 cigarettes per day
Standard Deviation 4.51
|
8.2 cigarettes per day
Standard Deviation 2.09
|
8.8 cigarettes per day
Standard Deviation 2.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day 4
|
—
|
15.7 cigarettes per day
Standard Deviation 3.88
|
8.1 cigarettes per day
Standard Deviation 2.20
|
8.7 cigarettes per day
Standard Deviation 2.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day 5
|
—
|
16.1 cigarettes per day
Standard Deviation 4.51
|
8.2 cigarettes per day
Standard Deviation 2.27
|
8.6 cigarettes per day
Standard Deviation 2.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day 6
|
—
|
15.5 cigarettes per day
Standard Deviation 4.00
|
8.2 cigarettes per day
Standard Deviation 2.14
|
8.7 cigarettes per day
Standard Deviation 2.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cigarette Consumption by Study Group and Study Day (mITT Population)
Day 7
|
—
|
17.1 cigarettes per day
Standard Deviation 4.43
|
8.2 cigarettes per day
Standard Deviation 2.10
|
8.8 cigarettes per day
Standard Deviation 2.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of VERVE® Product Used Per Day by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=41 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=42 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=41 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=41 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Day 7
|
4.4 products per day
Standard Deviation 2.38
|
3.8 products per day
Standard Deviation 1.99
|
4.0 products per day
Standard Deviation 2.44
|
5.4 products per day
Standard Deviation 3.04
|
4.6 products per day
Standard Deviation 2.99
|
6.1 products per day
Standard Deviation 4.81
|
8.1 products per day
Standard Deviation 5.41
|
6.2 products per day
Standard Deviation 3.93
|
10.2 products per day
Standard Deviation 7.00
|
6.7 products per day
Standard Deviation 4.99
|
5.3 products per day
Standard Deviation 4.65
|
8.8 products per day
Standard Deviation 6.08
|
|
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Day 1
|
3.9 products per day
Standard Deviation 2.31
|
4.2 products per day
Standard Deviation 2.41
|
3.5 products per day
Standard Deviation 2.73
|
6.3 products per day
Standard Deviation 3.74
|
3.0 products per day
Standard Deviation 1.74
|
5.8 products per day
Standard Deviation 2.78
|
8.9 products per day
Standard Deviation 6.29
|
4.8 products per day
Standard Deviation 6.41
|
11.5 products per day
Standard Deviation 8.87
|
9.0 products per day
Standard Deviation 5.88
|
4.5 products per day
Standard Deviation 3.79
|
10.9 products per day
Standard Deviation 7.38
|
|
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Day 2
|
3.3 products per day
Standard Deviation 1.95
|
3.6 products per day
Standard Deviation 2.02
|
4.2 products per day
Standard Deviation 2.17
|
6.5 products per day
Standard Deviation 2.96
|
3.4 products per day
Standard Deviation 1.42
|
5.2 products per day
Standard Deviation 2.36
|
8.2 products per day
Standard Deviation 6.37
|
6.9 products per day
Standard Deviation 8.76
|
11.6 products per day
Standard Deviation 8.60
|
7.7 products per day
Standard Deviation 5.35
|
6.9 products per day
Standard Deviation 4.87
|
10.4 products per day
Standard Deviation 7.71
|
|
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Day 3
|
3.6 products per day
Standard Deviation 2.13
|
3.9 products per day
Standard Deviation 2.05
|
3.7 products per day
Standard Deviation 1.76
|
6.0 products per day
Standard Deviation 2.77
|
3.5 products per day
Standard Deviation 1.38
|
5.6 products per day
Standard Deviation 2.76
|
7.8 products per day
Standard Deviation 5.64
|
7.7 products per day
Standard Deviation 9.61
|
11.0 products per day
Standard Deviation 9.61
|
8.2 products per day
Standard Deviation 5.75
|
6.0 products per day
Standard Deviation 4.46
|
10.2 products per day
Standard Deviation 7.03
|
|
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Day 4
|
3.7 products per day
Standard Deviation 2.76
|
3.9 products per day
Standard Deviation 2.35
|
3.6 products per day
Standard Deviation 2.32
|
5.8 products per day
Standard Deviation 3.14
|
3.9 products per day
Standard Deviation 2.08
|
5.6 products per day
Standard Deviation 3.15
|
8.3 products per day
Standard Deviation 6.98
|
8.7 products per day
Standard Deviation 8.70
|
10.8 products per day
Standard Deviation 9.22
|
7.0 products per day
Standard Deviation 4.73
|
6.5 products per day
Standard Deviation 4.79
|
9.7 products per day
Standard Deviation 6.93
|
|
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Day 5
|
3.5 products per day
Standard Deviation 1.87
|
3.3 products per day
Standard Deviation 2.10
|
3.6 products per day
Standard Deviation 1.72
|
5.4 products per day
Standard Deviation 2.34
|
3.5 products per day
Standard Deviation 1.67
|
5.7 products per day
Standard Deviation 2.82
|
7.9 products per day
Standard Deviation 7.15
|
10.7 products per day
Standard Deviation 10.26
|
11.5 products per day
Standard Deviation 11.13
|
7.1 products per day
Standard Deviation 5.17
|
6.5 products per day
Standard Deviation 4.84
|
9.4 products per day
Standard Deviation 7.33
|
|
Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population)
Day 6
|
3.9 products per day
Standard Deviation 2.78
|
4.0 products per day
Standard Deviation 2.30
|
3.6 products per day
Standard Deviation 2.30
|
5.8 products per day
Standard Deviation 2.73
|
4.4 products per day
Standard Deviation 2.75
|
6.2 products per day
Standard Deviation 4.50
|
6.9 products per day
Standard Deviation 5.89
|
9.9 products per day
Standard Deviation 9.83
|
10.1 products per day
Standard Deviation 9.42
|
6.0 products per day
Standard Deviation 4.31
|
6.2 products per day
Standard Deviation 5.10
|
8.5 products per day
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of average VERVE® product use duration (minutes) by Study Group and Study Day is presented. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=41 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=42 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=41 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=41 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Day 2
|
16.17 minutes
Standard Deviation 8.430
|
17.77 minutes
Standard Deviation 12.379
|
20.10 minutes
Standard Deviation 10.256
|
18.03 minutes
Standard Deviation 8.374
|
15.46 minutes
Standard Deviation 4.755
|
16.41 minutes
Standard Deviation 7.557
|
19.75 minutes
Standard Deviation 12.736
|
24.28 minutes
Standard Deviation 18.445
|
20.67 minutes
Standard Deviation 13.519
|
23.75 minutes
Standard Deviation 16.970
|
23.98 minutes
Standard Deviation 16.273
|
23.31 minutes
Standard Deviation 15.503
|
|
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Day 3
|
17.52 minutes
Standard Deviation 10.282
|
17.83 minutes
Standard Deviation 11.425
|
19.40 minutes
Standard Deviation 13.169
|
18.43 minutes
Standard Deviation 11.026
|
18.10 minutes
Standard Deviation 7.953
|
17.66 minutes
Standard Deviation 8.972
|
22.19 minutes
Standard Deviation 14.651
|
17.35 minutes
Standard Deviation 10.420
|
21.50 minutes
Standard Deviation 14.545
|
24.37 minutes
Standard Deviation 16.063
|
23.20 minutes
Standard Deviation 17.406
|
23.92 minutes
Standard Deviation 15.846
|
|
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Day 1
|
16.81 minutes
Standard Deviation 7.429
|
16.91 minutes
Standard Deviation 9.058
|
19.06 minutes
Standard Deviation 7.981
|
17.37 minutes
Standard Deviation 7.486
|
15.40 minutes
Standard Deviation 4.389
|
16.38 minutes
Standard Deviation 6.312
|
21.04 minutes
Standard Deviation 12.430
|
36.07 minutes
Standard Deviation 60.238
|
24.49 minutes
Standard Deviation 20.627
|
24.03 minutes
Standard Deviation 13.900
|
28.80 minutes
Standard Deviation 29.840
|
23.40 minutes
Standard Deviation 14.369
|
|
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Day 4
|
18.63 minutes
Standard Deviation 14.374
|
15.78 minutes
Standard Deviation 7.870
|
19.65 minutes
Standard Deviation 9.810
|
16.73 minutes
Standard Deviation 7.420
|
15.56 minutes
Standard Deviation 5.719
|
17.42 minutes
Standard Deviation 11.163
|
23.67 minutes
Standard Deviation 16.357
|
18.55 minutes
Standard Deviation 11.495
|
23.33 minutes
Standard Deviation 15.876
|
27.80 minutes
Standard Deviation 22.588
|
33.71 minutes
Standard Deviation 35.998
|
26.30 minutes
Standard Deviation 22.554
|
|
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Day 5
|
17.67 minutes
Standard Deviation 10.156
|
21.38 minutes
Standard Deviation 13.978
|
23.22 minutes
Standard Deviation 14.124
|
20.20 minutes
Standard Deviation 11.398
|
16.96 minutes
Standard Deviation 8.840
|
17.48 minutes
Standard Deviation 10.334
|
22.81 minutes
Standard Deviation 17.683
|
21.08 minutes
Standard Deviation 14.347
|
21.76 minutes
Standard Deviation 17.151
|
25.71 minutes
Standard Deviation 20.315
|
35.75 minutes
Standard Deviation 34.492
|
29.26 minutes
Standard Deviation 28.160
|
|
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Day 6
|
16.45 minutes
Standard Deviation 8.468
|
17.87 minutes
Standard Deviation 11.063
|
23.23 minutes
Standard Deviation 14.472
|
18.77 minutes
Standard Deviation 9.691
|
16.94 minutes
Standard Deviation 5.422
|
16.77 minutes
Standard Deviation 6.913
|
24.05 minutes
Standard Deviation 19.149
|
17.98 minutes
Standard Deviation 12.472
|
23.86 minutes
Standard Deviation 18.887
|
28.84 minutes
Standard Deviation 24.557
|
30.48 minutes
Standard Deviation 23.753
|
27.44 minutes
Standard Deviation 22.541
|
|
Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population)
Day 7
|
17.48 minutes
Standard Deviation 11.218
|
20.48 minutes
Standard Deviation 21.835
|
23.28 minutes
Standard Deviation 14.382
|
19.92 minutes
Standard Deviation 12.807
|
18.20 minutes
Standard Deviation 11.249
|
16.31 minutes
Standard Deviation 8.677
|
25.74 minutes
Standard Deviation 18.642
|
16.95 minutes
Standard Deviation 10.356
|
23.94 minutes
Standard Deviation 17.928
|
29.14 minutes
Standard Deviation 24.030
|
33.44 minutes
Standard Deviation 24.807
|
28.08 minutes
Standard Deviation 23.037
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7Population: Modified ITT: All randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure
Summary of total duration (minutes) of VERVE® product per day by Study Group and Study Day. Only study groups that received the test product (VERVE® Discs or VERVE® Chews) are shown. Results are stratified by product flavor (Green Mint, Blue Mint and overall).
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=41 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=42 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
n=41 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
n=41 Participants
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
n=26 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
n=28 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Day 1
|
62.8 minutes
Standard Deviation 57.27
|
66.6 minutes
Standard Deviation 60.86
|
53.3 minutes
Standard Deviation 35.94
|
96.4 minutes
Standard Deviation 73.30
|
43.3 minutes
Standard Deviation 28.82
|
87.0 minutes
Standard Deviation 59.79
|
157.8 minutes
Standard Deviation 128.82
|
68.2 minutes
Standard Deviation 69.75
|
181.8 minutes
Standard Deviation 124.40
|
176.2 minutes
Standard Deviation 140.91
|
66.8 minutes
Standard Deviation 52.65
|
190.0 minutes
Standard Deviation 150.02
|
|
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Day 2
|
54.4 minutes
Standard Deviation 64.55
|
55.4 minutes
Standard Deviation 43.38
|
75.0 minutes
Standard Deviation 65.29
|
106.1 minutes
Standard Deviation 93.40
|
45.0 minutes
Standard Deviation 20.73
|
75.8 minutes
Standard Deviation 59.77
|
136.1 minutes
Standard Deviation 123.65
|
106.6 minutes
Standard Deviation 127.33
|
167.1 minutes
Standard Deviation 133.55
|
158.1 minutes
Standard Deviation 143.12
|
127.4 minutes
Standard Deviation 134.79
|
180.0 minutes
Standard Deviation 157.77
|
|
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Day 3
|
55.8 minutes
Standard Deviation 47.73
|
58.9 minutes
Standard Deviation 45.94
|
70.4 minutes
Standard Deviation 77.83
|
95.8 minutes
Standard Deviation 85.57
|
53.7 minutes
Standard Deviation 28.27
|
81.2 minutes
Standard Deviation 57.39
|
143.3 minutes
Standard Deviation 155.53
|
94.8 minutes
Standard Deviation 124.33
|
165.8 minutes
Standard Deviation 157.13
|
168.0 minutes
Standard Deviation 158.06
|
112.3 minutes
Standard Deviation 118.36
|
183.9 minutes
Standard Deviation 161.66
|
|
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Day 4
|
59.2 minutes
Standard Deviation 65.29
|
53.3 minutes
Standard Deviation 50.87
|
56.4 minutes
Standard Deviation 50.96
|
78.7 minutes
Standard Deviation 60.02
|
51.8 minutes
Standard Deviation 36.46
|
76.1 minutes
Standard Deviation 62.69
|
147.1 minutes
Standard Deviation 151.60
|
107.4 minutes
Standard Deviation 107.71
|
160.0 minutes
Standard Deviation 146.22
|
160.5 minutes
Standard Deviation 169.97
|
143.5 minutes
Standard Deviation 144.53
|
193.0 minutes
Standard Deviation 192.40
|
|
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Day 5
|
52.0 minutes
Standard Deviation 51.65
|
55.5 minutes
Standard Deviation 40.23
|
70.5 minutes
Standard Deviation 71.71
|
87.8 minutes
Standard Deviation 76.80
|
52.9 minutes
Standard Deviation 48.87
|
74.8 minutes
Standard Deviation 58.45
|
143.7 minutes
Standard Deviation 160.99
|
122.5 minutes
Standard Deviation 96.15
|
160.9 minutes
Standard Deviation 163.65
|
154.5 minutes
Standard Deviation 159.58
|
161.8 minutes
Standard Deviation 174.46
|
191.8 minutes
Standard Deviation 185.32
|
|
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Day 6
|
57.4 minutes
Standard Deviation 56.87
|
51.9 minutes
Standard Deviation 32.63
|
62.2 minutes
Standard Deviation 55.51
|
82.7 minutes
Standard Deviation 58.15
|
60.3 minutes
Standard Deviation 50.07
|
74.8 minutes
Standard Deviation 60.34
|
148.0 minutes
Standard Deviation 182.96
|
114.1 minutes
Standard Deviation 115.23
|
166.3 minutes
Standard Deviation 176.75
|
157.0 minutes
Standard Deviation 183.23
|
173.3 minutes
Standard Deviation 213.39
|
191.0 minutes
Standard Deviation 206.39
|
|
Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population)
Day 7
|
60.9 minutes
Standard Deviation 46.53
|
55.2 minutes
Standard Deviation 40.88
|
75.7 minutes
Standard Deviation 62.68
|
82.5 minutes
Standard Deviation 63.51
|
73.8 minutes
Standard Deviation 71.37
|
76.3 minutes
Standard Deviation 77.57
|
164.3 minutes
Standard Deviation 170.36
|
92.2 minutes
Standard Deviation 121.70
|
167.4 minutes
Standard Deviation 164.72
|
154.0 minutes
Standard Deviation 173.42
|
136.8 minutes
Standard Deviation 132.81
|
182.8 minutes
Standard Deviation 178.99
|
SECONDARY outcome
Timeframe: Data collected on Day 7 at 21:30 (±30 minutes) during the product use periodPopulation: The mITT population consisted of all randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Only subjects who were smoked their own cigarette brand were asked to complete the "Use Product (Cigarette) Again" VAS score.
Summary of subject responses to "Use the Product (Cigarette) Again" Bipolar Visual Analogue Scale (VAS) Scores for cigarettes is presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to \<0, 0, and \>0 to 50. Higher scores are associated with greater willingness to use the cigarettes again. Mean and standard deviation of the bipolar VAS score per category is shown. The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to \<0', '0' and '\>0 to 50').
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=38 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=39 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
-50 to <0
|
—
|
-3.0 units on a scale
|
-20.7 units on a scale
Standard Deviation 18.14
|
-17.0 units on a scale
Standard Deviation 15.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
0
|
—
|
0.0 units on a scale
|
0.0 units on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
>0 to 50
|
—
|
37.3 units on a scale
Standard Deviation 14.67
|
37.1 units on a scale
Standard Deviation 14.92
|
30.8 units on a scale
Standard Deviation 16.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collected on Day 7 at 21:30 (±30 minutes) during the product use periodPopulation: The mITT population consisted of all randomized subjects who used at least one study product after randomization (except Group 6) and had a valid baseline and at least one post-baseline biomarker measure. Only subjects who used the VERVE® product were asked to complete the "Use Product (VERVE®) Again" VAS score.
Summary of subject responses to "Use the Product (VERVE®) Again" Bipolar Visual Analogue Scale (VAS) Scores for the VERVE® test products are presented. The Use the Product Again Bipolar VAS is a 100 mm scale ranging from 0 mm ("Definitely Would Not") to 100 mm ("Definitely Would"). The bipolar score is calculated by subtracting 50 from the original VAS score, then categorizing into three categories: -50 to \<0, 0, and \>0 to 50. Higher scores are associated with greater willingness to use the VERVE® product again. Mean and standard deviation of the bipolar VAS score per category is shown. The "Use the Product Again" VAS Score was given to subjects on Day 7 at 21:30 (±30 minutes) during the product use period. The data shown are the means calculated from only those participants with scores in the corresponding category ('-50 to \<0', '0' and '\>0 to 50').
Outcome measures
| Measure |
GROUP 4: OTDN Product 1
n=25 Participants
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 1: Continue Smoking
n=42 Participants
Subjects will be asked to continue smoking their own brand of cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=40 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs)
|
GROUP 3: OTDN Product 2
n=25 Participants
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 5: OTDN Product 2
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews)
|
GROUP 6: Tobacco Cessation
Subjects will completely stop all tobacco product usage for 7 days.
|
GROUP 4: OTDN Product 1 (VERVE® Green Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Green Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Blue Mint Discs)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Blue Mint Discs)
|
GROUP 4: OTDN Product 1 (VERVE® Discs Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product (VERVE® Discs Total)
|
GROUP 5: OTDN Product 2 (VERVE® Green Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Green Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Blue Mint Chews)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Blue Mint Chews)
|
GROUP 5: OTDN Product 2 (VERVE® Chews Total)
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product (VERVE® Chews Total)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
-50 to <0
|
-27.3 units on a scale
Standard Deviation 15.70
|
-36.5 units on a scale
Standard Deviation 18.92
|
-27.1 units on a scale
Standard Deviation 19.59
|
-30.7 units on a scale
Standard Deviation 19.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
0
|
0.0 units on a scale
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population)
>0 to 50
|
31.0 units on a scale
Standard Deviation 15.59
|
25.4 units on a scale
Standard Deviation 14.02
|
29.1 units on a scale
Standard Deviation 13.02
|
27.6 units on a scale
Standard Deviation 17.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Product Trial
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
GROUP 1: Continue Smoking
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GROUP 2: OTDN Product 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
GROUP 3: OTDN Product 2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
GROUP 4: OTDN Product 1
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
GROUP 5: OTDN Product 2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
GROUP 6: Tobacco Cessation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Product Trial
n=231 participants at risk；n=18 participants at risk
All subjects who used a study product during the product trial period, including subjects who were discontinued from the study before randomization and subjects who were randomized to one of the six study groups.
|
GROUP 1: Continue Smoking
n=40 participants at risk
Subjects will be asked to continue smoking their OB cigarettes ad libitum for 7 days.
|
GROUP 2: OTDN Product 1
n=42 participants at risk
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product
|
GROUP 3: OTDN Product 2
n=41 participants at risk
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product
|
GROUP 4: OTDN Product 1
n=30 participants at risk
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 1: Oral tobacco-derived nicotine product
|
GROUP 5: OTDN Product 2
n=30 participants at risk
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
OTDN product 2: Oral tobacco-derived nicotine product
|
GROUP 6: Tobacco Cessation
n=30 participants at risk
Subjects will completely stop all tobacco product usage for 7 days.
Tobacco Cessation: Tobacco Cessation
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
3/231 • Number of events 3 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Eye disorders
Eye irritation
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.87%
2/231 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
2/231 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
5/231 • Number of events 5 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
7.3%
3/41 • Number of events 3 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
3/231 • Number of events 3 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Gingival pain
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
5/231 • Number of events 5 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
General disorders
Drug withdrawal syndrome
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
General disorders
Feeling hot
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Infections and infestations
Pyuria
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
23.3%
7/30 • Number of events 7 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
13.3%
4/30 • Number of events 4 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Investigations
Blood glucose increased
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Investigations
Sputum abnormal
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
4/231 • Number of events 4 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
7.1%
3/42 • Number of events 3 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.87%
2/231 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Nervous system disorders
Headache
|
19.5%
45/231 • Number of events 47 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
7.1%
3/42 • Number of events 3 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
12.2%
5/41 • Number of events 5 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
13.3%
4/30 • Number of events 4 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Nervous system disorders
Tension headache
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.43%
1/231 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.87%
2/231 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
4.9%
2/41 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/231 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous abscess
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
|
Vascular disorders
Hot flush
|
0.43%
1/231 • Number of events 1 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/40 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/42 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/41 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
0.00%
0/30 • Adverse events were collected from subjects' first study product use [VERVE® product trial on Day -3] through discharge on Day 8 or Early Termination for a total of up to 11 days.
The Safety Population includes all subjects who tried the test product at least once during the study, including those subjects who participated only in the product trial phase. AEs will be monitored and recorded from the time of the first product use (VERVE® product trial at Check-in on Day -3) through the End-of-Study (or Early Termination). Events captured between Screening and the first study product use will be documented as baseline signs and symptoms (in medical history) and not AEs.
|
Additional Information
Jeffery Edmiston, Functional Director Clinical Research
Altria
Phone: 8043352366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place