Trial Outcomes & Findings for Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers (NCT NCT02964182)
NCT ID: NCT02964182
Last Updated: 2025-12-09
Results Overview
Mean usual brand cigarettes per day (CPD) smoked during the phase
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
One to three weeks
Results posted on
2025-12-09
Participant Flow
Participants were adults residing in the Houston metropolitan area
Overall, 1129 individuals were screened for interest and eligibility. Of those screened, 461 were ineligible and 455 declined to participate. A total of 213 participants were randomized.
Participant milestones
| Measure |
Phase 2: Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
Phase 3 VLNCCs + Low-dose ECs, Then Phase 4 VLNCCs + High-dose ECs (JUUL Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine)
|
Phase 1: Usual Brand Cigarette Phase (eGo Arm)
One week of smoking usual brand cigarettes
|
Phase 2: Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
Phase 3 VLNCCs + Low-dose Electronic Cigarettes (ECs), Then Phase 4 VLNCCs + High-dose ECs (eGo Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine)
|
Phase 3 VLNCCs + High-dose Electronic Cigarettes (ECs), Then Phase 4 VLNCCs + Low-dose ECs (eGo Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine)
|
Phase 1: Usual Brand Cigarette Phase (JUUL Arm)
One week of smoking usual brand cigarettes
|
Phase 3 VLNCCs + High-dose ECs, Then Phase 4 VLNCCs + Low-dose ECs (JUUL Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine)
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Week 1)
STARTED
|
0
|
0
|
176
|
0
|
0
|
0
|
37
|
0
|
|
Phase 1 (Week 1)
COMPLETED
|
0
|
0
|
176
|
0
|
0
|
0
|
37
|
0
|
|
Phase 1 (Week 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 (Weeks 2-4)
STARTED
|
37
|
0
|
0
|
176
|
0
|
0
|
0
|
0
|
|
Phase 2 (Weeks 2-4)
COMPLETED
|
22
|
0
|
0
|
158
|
0
|
0
|
0
|
0
|
|
Phase 2 (Weeks 2-4)
NOT COMPLETED
|
15
|
0
|
0
|
18
|
0
|
0
|
0
|
0
|
|
Phase 3 (Weeks 5-7)
STARTED
|
0
|
10
|
0
|
0
|
78
|
80
|
0
|
12
|
|
Phase 3 (Weeks 5-7)
COMPLETED
|
0
|
9
|
0
|
0
|
72
|
73
|
0
|
9
|
|
Phase 3 (Weeks 5-7)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
6
|
7
|
0
|
3
|
|
Phase 4 (Weeks 8-10)
STARTED
|
0
|
9
|
0
|
0
|
72
|
73
|
0
|
9
|
|
Phase 4 (Weeks 8-10)
COMPLETED
|
0
|
8
|
0
|
0
|
68
|
70
|
0
|
9
|
|
Phase 4 (Weeks 8-10)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
4
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 2: Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
Phase 3 VLNCCs + Low-dose ECs, Then Phase 4 VLNCCs + High-dose ECs (JUUL Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine)
|
Phase 1: Usual Brand Cigarette Phase (eGo Arm)
One week of smoking usual brand cigarettes
|
Phase 2: Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
Phase 3 VLNCCs + Low-dose Electronic Cigarettes (ECs), Then Phase 4 VLNCCs + High-dose ECs (eGo Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine)
|
Phase 3 VLNCCs + High-dose Electronic Cigarettes (ECs), Then Phase 4 VLNCCs + Low-dose ECs (eGo Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine)
|
Phase 1: Usual Brand Cigarette Phase (JUUL Arm)
One week of smoking usual brand cigarettes
|
Phase 3 VLNCCs + High-dose ECs, Then Phase 4 VLNCCs + Low-dose ECs (JUUL Arm)
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine), followed by three weeks (Phase 4) of smoking VLNCCs and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine)
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Weeks 2-4)
Lost to Follow-up
|
2
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
|
Phase 2 (Weeks 2-4)
Physician Decision
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 (Weeks 2-4)
Withdrawal by Subject
|
1
|
0
|
0
|
11
|
0
|
0
|
0
|
0
|
|
Phase 3 (Weeks 5-7)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
3
|
2
|
0
|
0
|
|
Phase 3 (Weeks 5-7)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
5
|
0
|
3
|
|
Phase 4 (Weeks 8-10)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Phase 4 (Weeks 8-10)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
3
|
1
|
0
|
0
|
Baseline Characteristics
Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers
Baseline characteristics by cohort
| Measure |
eGo Arm
n=176 Participants
Participants enrolled in the eGo Arm of this crossover design trial
|
JUUL Arm
n=37 Participants
Participants enrolled in the JUUL Arm of this crossover design trial
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.34 years
STANDARD_DEVIATION 11.95 • n=9 Participants
|
43.65 years
STANDARD_DEVIATION 11.28 • n=6 Participants
|
41.74 years
STANDARD_DEVIATION 11.84 • n=9 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
96 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
117 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
19 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=9 Participants
|
35 Participants
n=6 Participants
|
194 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
88 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=9 Participants
|
20 Participants
n=6 Participants
|
95 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
21 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
176 participants
n=9 Participants
|
37 participants
n=6 Participants
|
213 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: One to three weeksMean usual brand cigarettes per day (CPD) smoked during the phase
Outcome measures
| Measure |
VLNCCs + High-dose Electronic Cigarettes Phase (JUUL Arm)
n=21 Participants
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine)
|
Usual Brand Cigarette Phase (eGo Arm)
n=176 Participants
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
n=168 Participants
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (eGo Arm)
n=146 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine)
|
VLNCCs + High-dose Electronic Cigarettes Phase (eGo Arm)
n=149 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine)
|
Usual Brand Cigarette Phase (JUUL Arm)
n=37 Participants
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
n=36 Participants
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (JUUL Arm)
n=18 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine)
|
|---|---|---|---|---|---|---|---|---|
|
Usual Brand Cigarettes Per Day
|
2.1429 Cigarettes per Day
Standard Error 1.146
|
15.803 Cigarettes per Day
Standard Error 0.5304
|
2.1563 Cigarettes per Day
Standard Error 0.5427
|
1.8353 Cigarettes per Day
Standard Error 0.5807
|
1.4931 Cigarettes per Day
Standard Error 0.5751
|
12.6171 Cigarettes per Day
Standard Error 0.9155
|
2.6665 Cigarettes per Day
Standard Error 0.9258
|
2.3042 Cigarettes per Day
Standard Error 1.219
|
PRIMARY outcome
Timeframe: One to three weeksPopulation: Participants were not provided with very low nicotine content cigarettes during the Usual Brand Cigarette Phase (Phase 1)
Mean very low nicotine content cigarettes per day (CPD) smoked during the phase
Outcome measures
| Measure |
VLNCCs + High-dose Electronic Cigarettes Phase (JUUL Arm)
n=21 Participants
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine)
|
Usual Brand Cigarette Phase (eGo Arm)
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
n=167 Participants
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (eGo Arm)
n=146 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine)
|
VLNCCs + High-dose Electronic Cigarettes Phase (eGo Arm)
n=149 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine)
|
Usual Brand Cigarette Phase (JUUL Arm)
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
n=36 Participants
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (JUUL Arm)
n=17 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine)
|
|---|---|---|---|---|---|---|---|---|
|
Very Low Nicotine Content Cigarettes Per Day
|
6.2979 Cigarettes per Day
Standard Error 1.9709
|
—
|
15.7421 Cigarettes per Day
Standard Error 0.9071
|
10.2652 Cigarettes per Day
Standard Error 0.932
|
10.5811 Cigarettes per Day
Standard Error 0.9285
|
—
|
12.8014 Cigarettes per Day
Standard Error 1.6928
|
6.5151 Cigarettes per Day
Standard Error 2.0882
|
PRIMARY outcome
Timeframe: One to three weeksGeometric means of the natural log of total nicotine equivalents (TNE), calculated as the sum of total nicotine, total cotinine, total 3'-hydroxycotinine and nicotine N-oxide excreted in urine
Outcome measures
| Measure |
VLNCCs + High-dose Electronic Cigarettes Phase (JUUL Arm)
n=20 Participants
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine)
|
Usual Brand Cigarette Phase (eGo Arm)
n=175 Participants
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
n=156 Participants
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (eGo Arm)
n=144 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine)
|
VLNCCs + High-dose Electronic Cigarettes Phase (eGo Arm)
n=140 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine)
|
Usual Brand Cigarette Phase (JUUL Arm)
n=37 Participants
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
n=21 Participants
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (JUUL Arm)
n=19 Participants
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine)
|
|---|---|---|---|---|---|---|---|---|
|
Total Nicotine Equivalents (TNE)
|
32.428008 ln(nmol/mL)
Interval 13.9272 to 75.5053
|
25.621411 ln(nmol/mL)
Interval 19.559 to 33.5628
|
5.37663 ln(nmol/mL)
Interval 3.775 to 7.6578
|
8.418756 ln(nmol/mL)
Interval 5.5973 to 12.6625
|
11.388661 ln(nmol/mL)
Interval 8.1578 to 15.899
|
35.052048 ln(nmol/mL)
Interval 22.5231 to 54.5506
|
5.414214 ln(nmol/mL)
Interval 1.8475 to 15.867
|
23.83952 ln(nmol/mL)
Interval 10.069 to 56.4426
|
Adverse Events
Usual Brand Cigarette Phase (eGo Arm)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
VLNCCs + Low-dose Electronic Cigarettes Phase (eGo Arm)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
VLNCCs + High-dose Electronic Cigarettes Phase (eGo Arm)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Usual Brand Cigarette Phase (JUUL Arm)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VLNCCs + Low-dose Electronic Cigarettes Phase (JUUL Arm)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VLNCCs + High-dose Electronic Cigarettes Phase (JUUL Arm)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Brand Cigarette Phase (eGo Arm)
n=176 participants at risk
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
n=176 participants at risk
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (eGo Arm)
n=151 participants at risk
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine)
|
VLNCCs + High-dose Electronic Cigarettes Phase (eGo Arm)
n=152 participants at risk
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine)
|
Usual Brand Cigarette Phase (JUUL Arm)
n=37 participants at risk
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
n=37 participants at risk
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (JUUL Arm)
n=19 participants at risk
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine)
|
VLNCCs + High-dose Electronic Cigarettes Phase (JUUL Arm)
n=21 participants at risk
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine)
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Lung Infection
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
Other adverse events
| Measure |
Usual Brand Cigarette Phase (eGo Arm)
n=176 participants at risk
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (eGo Arm)
n=176 participants at risk
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (eGo Arm)
n=151 participants at risk
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand low-dose electronic cigarettes (8 mg/ml freebase nicotine)
|
VLNCCs + High-dose Electronic Cigarettes Phase (eGo Arm)
n=152 participants at risk
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using eGo-brand high-dose electronic cigarettes (36 mg/ml freebase nicotine)
|
Usual Brand Cigarette Phase (JUUL Arm)
n=37 participants at risk
One week of smoking usual brand cigarettes
|
Very Low Nicotine Content Cigarette (VLNCC) Phase (JUUL Arm)
n=37 participants at risk
Three weeks of smoking very low nicotine content cigarette (VLNCC)
|
VLNCCs + Low-dose Electronic Cigarettes Phase (JUUL Arm)
n=19 participants at risk
Three weeks of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand low-dose electronic cigarettes (3%; 35 mg/ml protonated nicotine)
|
VLNCCs + High-dose Electronic Cigarettes Phase (JUUL Arm)
n=21 participants at risk
Three weeks (Phase 3) of smoking very low nicotine content cigarettes (VLNCCs) and using JUUL-brand high-dose electronic cigarettes (5%; 59 mg/ml protonated nicotine)
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
General disorders
Edema Limbs
|
0.00%
0/176 • 10 weeks
|
1.1%
2/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Investigations
Elevated Co Reading
|
0.57%
1/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Eye disorders
Eye Pain
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
General disorders
Fatigue
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
4.8%
1/21 • 10 weeks
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Folliculitis
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Gallbladder Pain
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
General disorders
General Disorders And Administration Site Conditions - Other, Specify
|
0.00%
0/176 • 10 weeks
|
1.1%
2/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Nervous system disorders
Headache
|
1.1%
2/176 • 10 weeks
|
2.3%
4/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Injury, poisoning and procedural complications
Injury, Poisioning, And Procedural Complications Other
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Psychiatric disorders
Irritability
|
0.57%
1/176 • 10 weeks
|
2.3%
4/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Contractions
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/176 • 10 weeks
|
1.1%
2/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Pharyngitis
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Psychiatric disorders
Psychiatric Disorders - Other, Specify
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Injury
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
5.3%
1/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Skin Infection
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/176 • 10 weeks
|
1.7%
3/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
1.3%
2/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Stomach Pain
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other, Specify
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Tooth Infection
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
1.3%
2/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
0.57%
1/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
1.3%
2/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/176 • 10 weeks
|
1.1%
2/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
2.7%
1/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.57%
1/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/176 • 10 weeks
|
1.1%
2/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.57%
1/176 • 10 weeks
|
2.8%
5/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/176 • 10 weeks
|
1.7%
3/176 • 10 weeks
|
1.3%
2/151 • 10 weeks
|
0.66%
1/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Ear and labyrinth disorders
Allergic Rhinitis
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/176 • 10 weeks
|
1.1%
2/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Metabolism and nutrition disorders
Appetite Decreased
|
0.00%
0/176 • 10 weeks
|
0.00%
0/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/176 • 10 weeks
|
1.1%
2/176 • 10 weeks
|
0.66%
1/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/19 • 10 weeks
|
0.00%
0/21 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/176 • 10 weeks
|
0.57%
1/176 • 10 weeks
|
0.00%
0/151 • 10 weeks
|
0.00%
0/152 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
0.00%
0/37 • 10 weeks
|
5.3%
1/19 • 10 weeks
|
4.8%
1/21 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place