Trial Outcomes & Findings for Japanese Post-Market Cohort Study (NCT NCT03020667)
NCT ID: NCT03020667
Last Updated: 2024-09-19
Results Overview
To measure the mean numbers of cigarettes smoked and IQOS with HeatSticks used, mean numbers/times of Other Tobacco and Nicotine containing Products (OTP) used. OTP: included all other tobacco and nicotine-containing products except IQOS.
Recruitment status
TERMINATED
Target enrollment
1124 participants
Primary outcome timeframe
CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time
Results posted on
2024-09-19
Participant Flow
525 CC smokers and 599 IQOS users were enrolled, 70 IQOS users initiated IQOS 3 months ago, 191 IQOS users initiated IQOS 6 months ago, 264 IQOS users initiated IQOS 9 months ago, 73 IQOS users initiated IQOS 12 months ago, and 1 IQOS user initiated IQOS 15 month ago. Note: only data collected of wave 1 participants was analyzed.
CC smokers: based on the date of enrollment. IQOS users: based on date of initiation of IQOS use (IQOS use time).
Participant milestones
| Measure |
CC Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
IQOS Users: 3 Months IQOS Use Time
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use Time
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use Time
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users 12 Months IQOS Use Time
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users 15 Months IQOS Use Time
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|
|
At Month 3
STARTED
|
525
|
70
|
0
|
0
|
0
|
0
|
|
At Month 3
COMPLETED
|
215
|
70
|
0
|
0
|
0
|
0
|
|
At Month 3
NOT COMPLETED
|
310
|
0
|
0
|
0
|
0
|
0
|
|
At Month 6
STARTED
|
215
|
70
|
191
|
0
|
0
|
0
|
|
At Month 6
COMPLETED
|
107
|
50
|
191
|
0
|
0
|
0
|
|
At Month 6
NOT COMPLETED
|
108
|
20
|
0
|
0
|
0
|
0
|
|
At Month 9
STARTED
|
107
|
50
|
191
|
264
|
0
|
0
|
|
At Month 9
COMPLETED
|
12
|
42
|
113
|
264
|
0
|
0
|
|
At Month 9
NOT COMPLETED
|
95
|
8
|
78
|
0
|
0
|
0
|
|
At Month 12
STARTED
|
12
|
42
|
113
|
264
|
73
|
0
|
|
At Month 12
COMPLETED
|
4
|
28
|
75
|
134
|
73
|
0
|
|
At Month 12
NOT COMPLETED
|
8
|
14
|
38
|
130
|
0
|
0
|
|
At Month 15
STARTED
|
4
|
28
|
75
|
134
|
73
|
1
|
|
At Month 15
COMPLETED
|
1
|
18
|
31
|
98
|
10
|
1
|
|
At Month 15
NOT COMPLETED
|
3
|
10
|
44
|
36
|
63
|
0
|
|
At Month 18
STARTED
|
1
|
18
|
31
|
98
|
10
|
1
|
|
At Month 18
COMPLETED
|
0
|
6
|
22
|
48
|
7
|
0
|
|
At Month 18
NOT COMPLETED
|
1
|
12
|
9
|
50
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Japanese Post-Market Cohort Study
Baseline characteristics by cohort
| Measure |
CC Smokers
n=525 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
IQOS Users
n=599 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
Total
n=1124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 9.16 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 8.67 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
396 Participants
n=5 Participants
|
511 Participants
n=7 Participants
|
907 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
525 Participants
n=5 Participants
|
599 Participants
n=7 Participants
|
1124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
525 participants
n=5 Participants
|
599 participants
n=7 Participants
|
1124 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: CC smokers: enrollment, IQOS users: 3-18 Months IQOS use timePopulation: CC smokers: at enrollment, IQOS users: 3-18 months IQOS use time
To measure the mean numbers of cigarettes smoked and IQOS with HeatSticks used, mean numbers/times of Other Tobacco and Nicotine containing Products (OTP) used. OTP: included all other tobacco and nicotine-containing products except IQOS.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=66 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
n=214 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
n=375 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
n=289 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
n=161 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
n=84 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
n=460 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Product Consumption
Mean number of cigarettes smoked per day
|
4.0 number of consumption per day
Standard Deviation 7.72
|
3.8 number of consumption per day
Standard Deviation 6.68
|
4.6 number of consumption per day
Standard Deviation 7.99
|
4.4 number of consumption per day
Standard Deviation 8.12
|
5.1 number of consumption per day
Standard Deviation 8.80
|
4.0 number of consumption per day
Standard Deviation 8.06
|
15.8 number of consumption per day
Standard Deviation 9.43
|
—
|
—
|
—
|
—
|
—
|
|
Product Consumption
Mean number of Heatsticks used per day
|
13.3 number of consumption per day
Standard Deviation 8.85
|
13.2 number of consumption per day
Standard Deviation 7.75
|
13.3 number of consumption per day
Standard Deviation 8.52
|
13.8 number of consumption per day
Standard Deviation 8.68
|
12.7 number of consumption per day
Standard Deviation 8.61
|
12.6 number of consumption per day
Standard Deviation 8.69
|
0.2 number of consumption per day
Standard Deviation 1.93
|
—
|
—
|
—
|
—
|
—
|
|
Product Consumption
Mean number/times of OTP used per day
|
1.8 number of consumption per day
Standard Deviation 6.00
|
2.0 number of consumption per day
Standard Deviation 5.41
|
2.6 number of consumption per day
Standard Deviation 7.97
|
2.5 number of consumption per day
Standard Deviation 7.41
|
2.3 number of consumption per day
Standard Deviation 6.33
|
2.5 number of consumption per day
Standard Deviation 5.84
|
0.5 number of consumption per day
Standard Deviation 2.18
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-upPopulation: IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up
To describe product use patterns in CC smokers and IQOS users by product use categories. Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-User/smoker: Total consumption of all products = 0, Other: Does not fit in any of the above categories and no 'missing'.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=70 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
n=241 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
n=419 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
n=310 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
n=158 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
n=84 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
n=525 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
n=215 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
n=107 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
n=12 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
n=4 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
n=1 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Product Use Patterns
Primarily IQOS (≥70% consumption of IQOS)
|
45 Participants
|
133 Participants
|
228 Participants
|
182 Participants
|
94 Participants
|
47 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Product Use Patterns
Primarily CC (≥70% consumption of CC )
|
8 Participants
|
16 Participants
|
44 Participants
|
36 Participants
|
26 Participants
|
15 Participants
|
430 Participants
|
204 Participants
|
91 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
|
Product Use Patterns
Mixed IQOS-CC (IQOS and CC use in 30% to 70%)
|
6 Participants
|
29 Participants
|
46 Participants
|
30 Participants
|
15 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Product Use Patterns
Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%)
|
1 Participants
|
15 Participants
|
22 Participants
|
13 Participants
|
11 Participants
|
12 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Product Use Patterns
Mixed CC-OTP (CC and OTP use in 30% to 70%)
|
2 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
16 Participants
|
7 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Product Use Patterns
Non-user/Smoker
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Product Use Patterns
Other
|
4 Participants
|
14 Participants
|
26 Participants
|
23 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Product Use Patterns
missing
|
4 Participants
|
28 Participants
|
47 Participants
|
23 Participants
|
0 Participants
|
0 Participants
|
65 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: IQOS users: 3-18 months IQOS use timePopulation: IQOS users: 3-18 months IQOS use time
To measure the percentage of product use in IQOS users based on IQOS use time. * IQOSi = percentage of IQOS use at time point i, * CCi = percentage of CC use at time point i, * OTPi = percentage of other tobacco products (OTP) use at time point i.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=70 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
n=241 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
n=419 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
n=310 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
n=158 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
n=84 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Product Use
% CC
|
17.5 percentage
Standard Deviation 29.0
|
17.0 percentage
Standard Deviation 27.54
|
19.6 percentage
Standard Deviation 31.18
|
18.2 percentage
Standard Deviation 30.34
|
21.7 percentage
Standard Deviation 34.23
|
19.2 percentage
Standard Deviation 33.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Rate of Product Use
%OTP
|
7.2 percentage
Standard Deviation 21.42
|
9.3 percentage
Standard Deviation 22.84
|
9.5 percentage
Standard Deviation 23.33
|
9.8 percentage
Standard Deviation 24.89
|
2.3 percentage
Standard Deviation 6.33
|
2.5 percentage
Standard Deviation 5.84
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Rate of Product Use
%IQOS
|
75.3 percentage
Standard Deviation 35.53
|
73.7 percentage
Standard Deviation 33.62
|
70.9 percentage
Standard Deviation 36.53
|
72.0 percentage
Standard Deviation 36.83
|
68.5 percentage
Standard Deviation 38.81
|
68.9 percentage
Standard Deviation 37.80
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-upPopulation: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up
To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=599 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
n=525 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tobacco and Nicotine-containing Products Cessation
|
5 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: IQOS users at enrollmentPopulation: IQOS users at enrollment
To describe the demographics characteristics of IQOS users by product use category: Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-Use: Total consumption of all products= 0, Other: Does not fit in any of the above categories and no 'missing'.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=305 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
n=52 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
n=64 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
n=25 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
n=12 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
n=1 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
n=39 Participants
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Demographics of Tobacco and Nicotine-containing Product Users
30-39 years of age
|
102 Participants
|
18 Participants
|
21 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Demographics of Tobacco and Nicotine-containing Product Users
40-49 years of age
|
128 Participants
|
18 Participants
|
25 Participants
|
11 Participants
|
7 Participants
|
0 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Demographics of Tobacco and Nicotine-containing Product Users
50-59 years of age
|
50 Participants
|
11 Participants
|
15 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Demographics of Tobacco and Nicotine-containing Product Users
60-69 years of age
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Demographics of Tobacco and Nicotine-containing Product Users
70-79 years of age
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Demographics of Tobacco and Nicotine-containing Product Users
Male
|
263 Participants
|
44 Participants
|
57 Participants
|
22 Participants
|
10 Participants
|
1 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Demographics of Tobacco and Nicotine-containing Product Users
20-29 years of age
|
20 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At enrollmentPopulation: CC smokers and IQOS users at enrollment
To record the smoking history (duration) in CC smokers and IQOS users, measured in years.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=512 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
n=492 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Smoking History (Duration)
|
15.2 years
Standard Deviation 11.84
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12.0 years
Standard Deviation 13.65
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—
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—
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—
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PRIMARY outcome
Timeframe: At enrollmentPopulation: CC smokers and IQOS users at enrollment
To record the smoking history (intensity) in CC smokers and IQOS users, measured in pack-years. One pack year is equivalent to smoking 20 cigarettes a day for one year.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=524 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
n=496 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Smoking History (Intensity)
|
17.4 pack years
Standard Deviation 9.12
|
17.0 pack years
Standard Deviation 10.00
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PRIMARY outcome
Timeframe: From enrollment up to 15 months follow-upPopulation: CC smokers who started to use IQOS during follow-up
To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=21 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration
|
9.8 years
Standard Deviation 11.47
|
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PRIMARY outcome
Timeframe: From enrollment up to 15 months follow-upPopulation: CC smokers who started to use IQOS during follow-up
To measure smoking intensity among CC smokers who started to use IQOS during follow-up, measured in pack years. One pack year is equivalent to smoking 20 cigarettes a day for one year.
Outcome measures
| Measure |
IQOS Users: 3 Months IQOS Use
n=21 Participants
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 6 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 9 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 12 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 15 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
IQOS Users: 18 Months IQOS Use
The criteria defining a "IQOS user" are listed in the section "Eligibility".
|
CC Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 3 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 6 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 9 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 12 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
CC Smokers After 15 Months Follow-up
The criteria defining a "CC smoker" are listed in the section "Eligibility".
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity
|
13.4 pack years
Standard Deviation 7.14
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Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place