Trial Outcomes & Findings for A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes (NCT NCT04019626)
NCT ID: NCT04019626
Last Updated: 2021-06-30
Results Overview
Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Baseline and 56 days
Results posted on
2021-06-30
Participant Flow
Participant milestones
| Measure |
Myblu Tobacco Flavor 2.5%
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL 5%
Use of JUUL 5% nicotine e-cigarette
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
45
|
46
|
44
|
21
|
|
Overall Study
COMPLETED
|
36
|
32
|
37
|
39
|
38
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
8
|
7
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some samples were missing
Baseline characteristics by cohort
| Measure |
Myblu Tobacco Flavor 2.5%
n=42 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=42 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=45 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=46 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=44 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 11.72 • n=42 Participants
|
37.8 years
STANDARD_DEVIATION 10.47 • n=42 Participants
|
40.3 years
STANDARD_DEVIATION 9.43 • n=45 Participants
|
40.3 years
STANDARD_DEVIATION 9.75 • n=46 Participants
|
39.7 years
STANDARD_DEVIATION 10.44 • n=44 Participants
|
39.6 years
STANDARD_DEVIATION 10.32 • n=219 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
18 Participants
n=45 Participants
|
20 Participants
n=46 Participants
|
18 Participants
n=44 Participants
|
84 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
27 Participants
n=45 Participants
|
26 Participants
n=46 Participants
|
26 Participants
n=44 Participants
|
135 Participants
n=219 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=219 Participants
|
|
3-hydroxypropylmercapturic acid (3-HPMA) amount excreted in urine
|
1592.5 ug/24 hours
STANDARD_DEVIATION 818.2 • n=42 Participants • Some samples were missing
|
1730.3 ug/24 hours
STANDARD_DEVIATION 1044.2 • n=42 Participants • Some samples were missing
|
1749.7 ug/24 hours
STANDARD_DEVIATION 780.1 • n=41 Participants • Some samples were missing
|
1919.0 ug/24 hours
STANDARD_DEVIATION 999.8 • n=45 Participants • Some samples were missing
|
2214.0 ug/24 hours
STANDARD_DEVIATION 1172.6 • n=44 Participants • Some samples were missing
|
1841.1 ug/24 hours
STANDARD_DEVIATION 963.0 • n=214 Participants • Some samples were missing
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
18 Participants
n=45 Participants
|
16 Participants
n=46 Participants
|
13 Participants
n=44 Participants
|
75 Participants
n=219 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
24 Participants
n=45 Participants
|
27 Participants
n=46 Participants
|
30 Participants
n=44 Participants
|
131 Participants
n=219 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=45 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=44 Participants
|
9 Participants
n=219 Participants
|
|
Body mass index (BMI)
|
28.0 kg/m^2
STANDARD_DEVIATION 4.7 • n=42 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 4.9 • n=42 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 4.7 • n=45 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 5.2 • n=46 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 5.6 • n=44 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 5.1 • n=219 Participants
|
|
Blood carboxyhemoglobin (COHb) %
|
4.9 % saturation
STANDARD_DEVIATION 2.2 • n=42 Participants
|
4.8 % saturation
STANDARD_DEVIATION 1.8 • n=42 Participants
|
4.8 % saturation
STANDARD_DEVIATION 2.1 • n=45 Participants
|
5.3 % saturation
STANDARD_DEVIATION 1.9 • n=46 Participants
|
5.7 % saturation
STANDARD_DEVIATION 2.0 • n=44 Participants
|
5.1 % saturation
STANDARD_DEVIATION 2.0 • n=219 Participants
|
|
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted in urine
|
411.0 ng/24 hours
STANDARD_DEVIATION 333.2 • n=42 Participants • Some samples were missing
|
406.8 ng/24 hours
STANDARD_DEVIATION 328.8 • n=42 Participants • Some samples were missing
|
410.4 ng/24 hours
STANDARD_DEVIATION 351.2 • n=41 Participants • Some samples were missing
|
479.4 ng/24 hours
STANDARD_DEVIATION 404.2 • n=45 Participants • Some samples were missing
|
513.7 ng/24 hours
STANDARD_DEVIATION 403.7 • n=44 Participants • Some samples were missing
|
444.26 ng/24 hours
STANDARD_DEVIATION 346.2 • n=214 Participants • Some samples were missing
|
|
S-phenyl mercapturic acid (S-PMA) amount excreted in urine
|
5.3 ug/24 hours
STANDARD_DEVIATION 3.7 • n=42 Participants • Some samples were missing
|
5.9 ug/24 hours
STANDARD_DEVIATION 4.3 • n=42 Participants • Some samples were missing
|
6.5 ug/24 hours
STANDARD_DEVIATION 5.1 • n=41 Participants • Some samples were missing
|
7.2 ug/24 hours
STANDARD_DEVIATION 5.2 • n=45 Participants • Some samples were missing
|
8.6 ug/24 hours
STANDARD_DEVIATION 5.9 • n=44 Participants • Some samples were missing
|
6.7 ug/24 hours
STANDARD_DEVIATION 4.8 • n=214 Participants • Some samples were missing
|
|
Nicotine equivalents amount excreted in urine
|
13.6 mg/24 hours
STANDARD_DEVIATION 6.8 • n=42 Participants • Some samples were missing
|
14.1 mg/24 hours
STANDARD_DEVIATION 7.5 • n=42 Participants • Some samples were missing
|
17.1 mg/24 hours
STANDARD_DEVIATION 13.3 • n=41 Participants • Some samples were missing
|
16.2 mg/24 hours
STANDARD_DEVIATION 6.5 • n=45 Participants • Some samples were missing
|
18.0 mg/24 hours
STANDARD_DEVIATION 7.3 • n=44 Participants • Some samples were missing
|
15.8 mg/24 hours
STANDARD_DEVIATION 8.3 • n=214 Participants • Some samples were missing
|
|
Level of white blood cells
|
7.7 cells*thousands/uL
STANDARD_DEVIATION 2.0 • n=42 Participants • Some samples were missing
|
7.0 cells*thousands/uL
STANDARD_DEVIATION 2.0 • n=40 Participants • Some samples were missing
|
6.8 cells*thousands/uL
STANDARD_DEVIATION 1.8 • n=45 Participants • Some samples were missing
|
7.4 cells*thousands/uL
STANDARD_DEVIATION 2.0 • n=46 Participants • Some samples were missing
|
7.2 cells*thousands/uL
STANDARD_DEVIATION 2.2 • n=44 Participants • Some samples were missing
|
7.2 cells*thousands/uL
STANDARD_DEVIATION 2.0 • n=217 Participants • Some samples were missing
|
PRIMARY outcome
Timeframe: Baseline and 56 daysPopulation: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (cf "Study Description"). Therefore, the number of subjects analysed in one arm may be different from the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=32 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=49 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=24 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=33 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=37 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Concentration of Carboxyhemoglobin in Blood
|
-59.6 % change from baseline
Standard Deviation 23.3
|
-62.7 % change from baseline
Standard Deviation 19.4
|
-46.4 % change from baseline
Standard Deviation 35.1
|
-62.7 % change from baseline
Standard Deviation 21.2
|
8.5 % change from baseline
Standard Deviation 28.3
|
—
|
PRIMARY outcome
Timeframe: Baseline and 56 daysPopulation: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL - a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) excreted in urine in 24-hours
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=32 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=52 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=25 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=35 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=38 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
|
-58.3 % change from baseline
Standard Deviation 72.8
|
-44.7 % change from baseline
Standard Deviation 150.5
|
-62.7 % change from baseline
Standard Deviation 36.2
|
-70.7 % change from baseline
Standard Deviation 33.7
|
1.1 % change from baseline
Standard Deviation 29.6
|
—
|
PRIMARY outcome
Timeframe: Baseline and 56 daysPopulation: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=32 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=52 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=25 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=35 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=38 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
|
-60.0 % change from baseline
Standard Deviation 28.2
|
-55.7 % change from baseline
Standard Deviation 46.1
|
-50.5 % change from baseline
Standard Deviation 36.2
|
-53.8 % change from baseline
Standard Deviation 64.5
|
1.6 % change from baseline
Standard Deviation 40.6
|
—
|
PRIMARY outcome
Timeframe: Baseline and 56 daysPopulation: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA - a biomarker of exposure to benzene) excreted in urine in 24-hours
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=32 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=52 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=25 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=35 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=38 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
|
-85.9 % change from baseline
Standard Deviation 32.5
|
-44.9 % change from baseline
Standard Deviation 257.5
|
-63.1 % change from baseline
Standard Deviation 79.3
|
-73.8 % change from baseline
Standard Deviation 55.7
|
-2.7 % change from baseline
Standard Deviation 38.4
|
—
|
SECONDARY outcome
Timeframe: Baseline and 56 daysPopulation: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=32 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=51 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=24 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=35 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=38 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Amount of Nicotine Equivalents in Urine in 24 Hours
|
-7.8 % change from baseline
Standard Deviation 74.0
|
16.6 % change from baseline
Standard Deviation 61.1
|
-13.8 % change from baseline
Standard Deviation 54.5
|
-1.3 % change from baseline
Standard Deviation 38.8
|
-7.0 % change from baseline
Standard Deviation 27.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 56 daysPopulation: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
The change from baseline in the level of white blood cells, which is a biomarker of potential harm
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=31 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=51 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=25 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=35 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=37 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Level of White Blood Cells
|
-9.2 % change from baseline
Standard Deviation 16.7
|
-4.3 % change from baseline
Standard Deviation 16.8
|
-8.7 % change from baseline
Standard Deviation 17.9
|
-8.5 % change from baseline
Standard Deviation 16.3
|
4.7 % change from baseline
Standard Deviation 17.0
|
—
|
SECONDARY outcome
Timeframe: 56 daysPopulation: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Nicotine withdrawal symptoms are measured using the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) questionnaire. The DSM-5 and craving items from the MTWS-R have been included. The subjects rate themselves on the questionnaire, which includes symptoms such as angry, irritable, frustrated, depressed mood, restless, insomnia. Each question is rated from 0 (none) to 4 (severe). Total scores may range from 0 to a maximum of 32.
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=31 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=51 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=26 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=33 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=38 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Subjective Measure: Nicotine Withdrawal Symptoms Total Score
|
8.6 score on a scale
Standard Deviation 6.7
|
5.7 score on a scale
Standard Deviation 5.5
|
7.1 score on a scale
Standard Deviation 5.3
|
6.8 score on a scale
Standard Deviation 5.8
|
8.1 score on a scale
Standard Deviation 5.9
|
—
|
SECONDARY outcome
Timeframe: 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dosePopulation: Sub-group of participants who participated in the PK sub-study, on Day 1
The maximum nicotine concentration in blood (Cmax)
Outcome measures
| Measure |
Myblu Tobacco Flavor 2.5%
n=20 Participants
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=19 Participants
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=19 Participants
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=22 Participants
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=24 Participants
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
n=19 Participants
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Maximum Nicotine Concentration in Blood
|
4.0 ng/mL
Geometric Coefficient of Variation 196.3
|
7.3 ng/mL
Geometric Coefficient of Variation 118.6
|
4.3 ng/mL
Geometric Coefficient of Variation 191.3
|
8.9 ng/mL
Geometric Coefficient of Variation 159.8
|
13.5 ng/mL
Geometric Coefficient of Variation 62.5
|
6.9 ng/mL
Geometric Coefficient of Variation 160.1
|
Adverse Events
Myblu Tobacco Flavor 2.5%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Myblu Tobacco Flavor 4.0%
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Myblu Honeymoon 2.5%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Myblu Honeymoon 4.0%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Continue-smoking
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
JUUL® 5.0%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Myblu Tobacco Flavor 2.5%
n=55 participants at risk
Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine
|
Myblu Tobacco Flavor 4.0%
n=71 participants at risk
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine
|
Myblu Honeymoon 2.5%
n=47 participants at risk
Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine
|
Myblu Honeymoon 4.0%
n=57 participants at risk
Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine
|
Continue-smoking
n=44 participants at risk
The subject's usual brand of combustible cigarette
Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
|
JUUL® 5.0%
n=21 participants at risk
Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
3/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
1.4%
1/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
4.5%
2/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
1.4%
1/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
4.8%
1/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
4.3%
2/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
3.5%
2/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
19.0%
4/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
4.8%
1/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
2.8%
2/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
2.3%
1/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
3.5%
2/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
4.2%
3/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Nervous system disorders
Headache
|
0.00%
0/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
1.4%
1/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
8.5%
4/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
3.5%
2/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
9.1%
4/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
3/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
2.8%
2/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
4.8%
1/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/55 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/71 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/47 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/57 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
0.00%
0/44 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
4.8%
1/21 • 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place