Trial Outcomes & Findings for Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use (NCT NCT04084210)
NCT ID: NCT04084210
Last Updated: 2023-05-25
Results Overview
The mean number of conventional cigarettes smoked during each Switch Week will be used as a measure for conventional cigarette usage.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
209 participants
Primary outcome timeframe
During the two 1-week switching periods
Results posted on
2023-05-25
Participant Flow
Participants from the greater Madison and Milwaukee, WI areas were recruited via media recruitment methods (i.e., TV, newspaper, and earned media) and paid Facebook advertisements. Of the 2036 potential participants, 209 (10.3%) were eligible, provided consent and were randomized. Of those randomized, 160 completed both switch weeks and were included in the analyses.
Participant milestones
| Measure |
Juul + Active Patch in Wk 1 and Placebo Patch in Wk 2
Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Juul Electronic cigarette: The juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
Juul + Placebo Patch in Wk 1 and Active Patch in Wk 2
Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1, participants also will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
Juul Electronic cigarette: The juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
VLNC + Active Patch in Wk 1 and Placebo Patch in Wk 2
Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
VLNC + Placebo Patch in Wk 1 and Active Patch in Wk 2
Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1, participants also will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
No Product + Active Patch in Wk 1 and Placebo Patch in Wk 2
Participants will be given no alternative nicotine delivery products but in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
No Product + Placebo Patch in Wk 1 and Active Patch in Wk 2
Participants will be given no alternative nicotine delivery products for two weeks but in Switch Week 1 participants will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
37
|
36
|
34
|
36
|
|
Overall Study
COMPLETED
|
27
|
27
|
29
|
24
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
8
|
12
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
See added Baseline Measure Sex/Gender Customized for Transgender participant.
Baseline characteristics by cohort
| Measure |
Juul + Active and Placebo Patch
n=54 Participants
Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
VLNC + Active and Placebo Patch
n=53 Participants
Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
No Product + Active and Placebo Patch
n=53 Participants
Participants will be given no alternative nicotine delivery products but in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.37 years
STANDARD_DEVIATION 9.57 • n=54 Participants
|
52.00 years
STANDARD_DEVIATION 13.26 • n=53 Participants
|
51.21 years
STANDARD_DEVIATION 13.22 • n=53 Participants
|
51.86 years
STANDARD_DEVIATION 12.06 • n=160 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=54 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=53 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
34 Participants
n=53 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
28 Participants
n=53 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
96 Participants
n=159 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
|
Sex: Female, Male
Male
|
19 Participants
n=53 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
19 Participants
n=53 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
25 Participants
n=53 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
63 Participants
n=159 Participants • See added Baseline Measure Sex/Gender Customized for Transgender participant.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=54 Participants
|
2 Participants
n=53 Participants
|
1 Participants
n=53 Participants
|
5 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=54 Participants
|
48 Participants
n=53 Participants
|
51 Participants
n=53 Participants
|
149 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
3 Participants
n=53 Participants
|
1 Participants
n=53 Participants
|
6 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
2 Participants
n=53 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=54 Participants
|
10 Participants
n=53 Participants
|
15 Participants
n=53 Participants
|
35 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=54 Participants
|
38 Participants
n=53 Participants
|
35 Participants
n=53 Participants
|
113 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=54 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=53 Participants
|
6 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
2 Participants
n=53 Participants
|
2 Participants
n=53 Participants
|
4 Participants
n=160 Participants
|
|
Cigarettes per day (CPD)
|
17.29 cigarettes per day
STANDARD_DEVIATION 9.89 • n=54 Participants
|
16.78 cigarettes per day
STANDARD_DEVIATION 9.3 • n=53 Participants
|
17.55 cigarettes per day
STANDARD_DEVIATION 9.59 • n=53 Participants
|
16.85 cigarettes per day
STANDARD_DEVIATION 9.34 • n=160 Participants
|
PRIMARY outcome
Timeframe: During the two 1-week switching periodsThe mean number of conventional cigarettes smoked during each Switch Week will be used as a measure for conventional cigarette usage.
Outcome measures
| Measure |
Juul + Active and Placebo Patch
n=54 Participants
Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
VLNC + Active and Placebo Patch
n=53 Participants
Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
No Product + Active and Placebo Patch
n=53 Participants
Participants will be given no alternative nicotine delivery products but in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
|---|---|---|---|
|
Mean Number of Conventional Cigarettes Smoked During Each Switch Week
Cigarettes per day during Placebo Patch Switch Week
|
3.2 Cigarettes per day
Standard Deviation 3.6
|
3.2 Cigarettes per day
Standard Deviation 4.8
|
5.8 Cigarettes per day
Standard Deviation 6.2
|
|
Mean Number of Conventional Cigarettes Smoked During Each Switch Week
Cigarettes per day during Active Patch Switch Week
|
3.1 Cigarettes per day
Standard Deviation 3.3
|
2.9 Cigarettes per day
Standard Deviation 4.6
|
5.1 Cigarettes per day
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: During the two 1-week switching periodsThe mean number of VLNCs smoked or vape events reported per day during each Switch Week will be used as a measure of alternative product use.
Outcome measures
| Measure |
Juul + Active and Placebo Patch
n=54 Participants
Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
VLNC + Active and Placebo Patch
n=53 Participants
Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
No Product + Active and Placebo Patch
n=53 Participants
Participants will be given no alternative nicotine delivery products but in Switch Week 1 - half of participants will use active nicotine patches and half will use placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 will use placebo patches, and the participants who received placebo patches during Switch Week 1 will use active nicotine patches.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo Patch: Placebo patch containing no nicotine.
|
|---|---|---|---|
|
Mean Number of VLNCs Smoked or Vape Events Per Day Reported During Each Switch Week
Product Use per day during Placebo Patch Switch Week
|
7.46 events per day
Standard Deviation 4.49
|
10.09 events per day
Standard Deviation 8.39
|
0.0 events per day
Standard Deviation 0.0
|
|
Mean Number of VLNCs Smoked or Vape Events Per Day Reported During Each Switch Week
Product Use per day during Active Patch Switch Week
|
6.61 events per day
Standard Deviation 3.82
|
8.64 events per day
Standard Deviation 6.99
|
0.0 events per day
Standard Deviation 0.0
|
Adverse Events
JUUL + Active Patch
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
JUUL + Placebo Patch
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
JUUL + No Patch
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
VLNC + Active Patch
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
VLNC + Placebo Patch
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
VLNC + No Patch
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
No Product + Active Patch
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
No Product + Placebo Patch
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
No Product + No Patch
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JUUL + Active Patch
n=54 participants at risk
Participants were given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using JUUL, but not using nicotine patches.
These data are AEs for subjects during the week that they were using JUUL and Active Patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
|
JUUL + Placebo Patch
n=54 participants at risk
Participants were given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using JUUL, but not using nicotine patches.
These data are AEs for subjects during the week that they were using JUUL and Placebo Patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Placebo Patch: Placebo patch containing no nicotine.
|
JUUL + No Patch
n=54 participants at risk
Participants were given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using JUUL, but not using nicotine patches.
These data are AEs for subjects during the weeks that they were using JUUL and No Patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
|
VLNC + Active Patch
n=53 participants at risk
Participants were given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using VLNC, but not using nicotine patches.
These data are AEs for subjects during the weeks that they were using VLNCs and Active Patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
|
VLNC + Placebo Patch
n=53 participants at risk
Participants were given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using VLNC, but not using nicotine patches.
These data are AEs for subjects during the week that they were using VLNCs and Placebo Patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Placebo Patch: Placebo patch containing no nicotine.
|
VLNC + No Patch
n=53 participants at risk
Participants were given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using VLNC, but not using nicotine patches.
These data are AEs for subjects during the week that they were using VLNC and No Patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
|
No Product + Active Patch
n=53 participants at risk
Participants were given no alternative nicotine delivery products but in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual but not using nicotine patches.
These data are AEs for subjects during the week that they were using No Product and Active Patches.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
|
No Product + Placebo Patch
n=53 participants at risk
Participants were given no alternative nicotine delivery products but in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual but not using nicotine patches.
These data are AEs for subjects during the week that they were using No Product and Placebo Patches.
Placebo Patch: Placebo patch containing no nicotine.
|
No Product + No Patch
n=53 participants at risk
Participants were given no alternative nicotine delivery products but in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual but not using nicotine patches.
These data are AEs for subjects during the week that they were using No Product and No Patches.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ruptured Ulcer
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Cardiac disorders
Stroke
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
Other adverse events
| Measure |
JUUL + Active Patch
n=54 participants at risk
Participants were given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using JUUL, but not using nicotine patches.
These data are AEs for subjects during the week that they were using JUUL and Active Patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
|
JUUL + Placebo Patch
n=54 participants at risk
Participants were given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using JUUL, but not using nicotine patches.
These data are AEs for subjects during the week that they were using JUUL and Placebo Patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
Placebo Patch: Placebo patch containing no nicotine.
|
JUUL + No Patch
n=54 participants at risk
Participants were given Juul e-cigarettes for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using JUUL, but not using nicotine patches.
These data are AEs for subjects during the weeks that they were using JUUL and No Patches.
Juul Electronic cigarette: The Juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
|
VLNC + Active Patch
n=53 participants at risk
Participants were given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using VLNC, but not using nicotine patches.
These data are AEs for subjects during the weeks that they were using VLNCs and Active Patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
|
VLNC + Placebo Patch
n=53 participants at risk
Participants were given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using VLNC, but not using nicotine patches.
These data are AEs for subjects during the week that they were using VLNCs and Placebo Patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Placebo Patch: Placebo patch containing no nicotine.
|
VLNC + No Patch
n=53 participants at risk
Participants were given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual and/or using VLNC, but not using nicotine patches.
These data are AEs for subjects during the week that they were using VLNC and No Patches.
Very Low Nicotine Cigarettes: These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
|
No Product + Active Patch
n=53 participants at risk
Participants were given no alternative nicotine delivery products but in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual but not using nicotine patches.
These data are AEs for subjects during the week that they were using No Product and Active Patches.
Active Nicotine Patch: Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
|
No Product + Placebo Patch
n=53 participants at risk
Participants were given no alternative nicotine delivery products but in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual but not using nicotine patches.
These data are AEs for subjects during the week that they were using No Product and Placebo Patches.
Placebo Patch: Placebo patch containing no nicotine.
|
No Product + No Patch
n=53 participants at risk
Participants were given no alternative nicotine delivery products but in Switch Week 1 - half of participants used active nicotine patches and half used placebo patches, in Switch Week 2 - the participants who received active nicotine patches during Switch Week 1 used placebo patches during Switch Week 2, and the participants who received placebo patches during Switch Week 1 used active nicotine patches during Switch Week 2. AEs were assessed during Switch Weeks as well as during times when participants were smoking as usual but not using nicotine patches.
These data are AEs for subjects during the week that they were using No Product and No Patches.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.6%
3/54 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Skin and subcutaneous tissue disorders
Itching or Hives
|
7.4%
4/54 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.7%
3/53 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.7%
3/53 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
7.5%
4/53 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
5.6%
3/54 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
7.5%
4/53 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Nervous system disorders
Insomnia
|
7.4%
4/54 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.6%
3/54 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.7%
3/53 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Nervous system disorders
Vivid Dreams
|
7.4%
4/54 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
7.5%
4/53 • Number of events 5 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.7%
3/53 • Number of events 5 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
3/54 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Nervous system disorders
Dizziness
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.6%
3/54 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.6%
3/54 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
General disorders
Weakness
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Cardiac disorders
Irregular Heartbeat
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Trouble Breathing
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/54 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
7/54 • Number of events 10 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
9.3%
5/54 • Number of events 6 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
16.7%
9/54 • Number of events 12 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
7.5%
4/53 • Number of events 5 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.7%
3/53 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
General disorders
Abdominal Pain
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
General disorders
Fever/Chills
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Blood and lymphatic system disorders
Swelling in face or hands
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
0.00%
0/53 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/54 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.7%
2/54 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
7.4%
4/54 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
7.5%
4/53 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.7%
3/53 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
5.7%
3/53 • Number of events 3 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
3.8%
2/53 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
1.9%
1/53 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 4 weeks.
|
Additional Information
Megan Piper, PhD, Director of Research Professor
University of Wisconsin- Madison
Phone: 608-265-5472
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place