Smoking, Tobacco Product
Conditions
Keywords
Cigarette, IQOS, Nicotine-containing product, Tobacco
Brief summary
The objectives and endpoints of this study were analyzed in the study population of adults eligible to purchase tobacco products. The study was planned to describe the patterns of use of tobacco and nicotine containing products and self-reported health outcomes and health related events in CC (Cigarette) smokers and IQOS users in Japan. The initial study record (posted on ClinicalTrials.gov) included a clinical sub-study designed to estimate population level differences in the biomarkers of exposure and clinical risk endpoints among IQOS users, CC smokers and never-smokers. However, due to low recruitment and retention of subjects, the clinical sub-study was terminated in May 2017, and for the same reasons the main study was terminated in March 2018. The study protocol was updated to remove the clinical sub-study objectives. The study initially included 18 outcome measures. Due to study termination leading to a shortened follow-up period and a smaller sample size, only 7 of these outcome measures could be assessed and the other outcome measures planned were either unattainable or uninformative.
Detailed description
This was a prospective, observational, cohort study of adults, eligible to purchase tobacco products in Japan. The study described the patterns of use of tobacco and nicotine containing products in CC smokers and IQOS users. For IQOS users, the date of initiation of IQOS use was the trigger for all study assessments in the study. However the process was different for CC smokers for whom assessment timing was based on the date of enrollment. IQOS users were enrolled into the study at least two months after initiating use of IQOS (to ensure adoption of IQOS), but less than 12 months after initiating use of IQOS. The study assessments started at the next appropriate study time point after enrollment. Participants were recruited from consumer databases and/or through advertisement. Responses from all eligible participants in the study were collected online using computer assisted self-interviews (CASIs). The questionnaires included demographic information, tobacco use questionnaire including detailed product use and intention to stop tobacco- and nicotine-containing product use, lifestyle assessments, social-economic status, risk perception, nicotine dependence, urge to smoke, as well as self-reported health outcomes. IQOS users were also administered the Modified Cigarette Evaluation Questionnaire, and Self-Reported Changes Questionnaire. The CASIs were administered at the enrollment and quarterly for the first 18 months (at Months 3, 6, 9, 12, 15 and 18). The study initially was planned to recruit 2,000 IQOS users and 2,000 cigarette (CC) smokers in 4 annual waves (500 IQOS users and 500 CC smokers per wave) and to be followed up to a maximum of 60 months. The first wave of recruitment competed in March 2017. During wave 2 recruitment the study was terminated. A total of 599 IQOS users and 525 CC smokers were enrolled. There was 1 reported protocol deviation in IQOS users, the participant had been using IQOS for 15 months. Due to study termination, only data collected for wave 1 was analyzed. As this study was observational by design and was conducted in a post-market setting, adverse event (AE) reporting followed the Sponsor's established post-market Safety Surveillance Procedures for spontaneously reported events. IQOS users were reminded of the product quality complaints (including AEs) hotline that is available for all IQOS consumers in Japan.
Interventions
None listed
Sponsors
Philip Morris Products S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult tobacco users in Japan (at least 20 years of age) * The participant is Japanese * Participant is able to understand the information provided in the Informed Consent form (ICF) * Signed ICF * Willing to participate in the study and has access to the internet * For IQOS users: * Is currently using IQOS with HeatSticks * Has used at least 100 HeatSticks with IQOS in their lifetime, and * Has used IQOS with HeatSticks for 2 months or more * For CC smokers: * Is currently using CC * Is not currently using IQOS with HeatSticks, and * Has used at least 100 CC in their lifetime
Exclusion criteria
* Tobacco industry employees * Employed by the Sponsor, CRO or Clinical Site * For IQOS users: * More than 12 months of IQOS use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Consumption | CC smokers: 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. |
| Product Use Patterns | 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'. |
| Rate of Product Use | 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. |
| Tobacco and Nicotine-containing Products Cessation | 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 |
| Demographics of Tobacco and Nicotine-containing Product Users | 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'. |
| Smoking History (Duration) | At enrollment | To record the smoking history (duration) in CC smokers and IQOS users, measured in years. |
| Smoking History (Intensity) | 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. |
| Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration | From enrollment up to 15 months follow-up | To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years. |
| Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity | From enrollment up to 15 months 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. |
Countries
Japan
Participant flow
Recruitment details
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.
Pre-assignment details
CC smokers: based on the date of enrollment. IQOS users: based on date of initiation of IQOS use (IQOS use time).
Participants by arm
| Arm | Count |
|---|---|
| CC Smokers The criteria defining a CC smoker are listed in the section Eligibility. | 525 |
| IQOS Users The criteria defining a IQOS user are listed in the section Eligibility. | 599 |
| Total | 1,124 |
Baseline characteristics
| Characteristic | CC Smokers | Total | IQOS Users |
|---|---|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 9.16 | 45.0 years STANDARD_DEVIATION 9.33 | 42.4 years STANDARD_DEVIATION 8.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 525 Participants | 1124 Participants | 599 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 525 participants | 1124 participants | 599 participants |
| Sex: Female, Male Female | 129 Participants | 217 Participants | 88 Participants |
| Sex: Female, Male Male | 396 Participants | 907 Participants | 511 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,124 |
| other Total, other adverse events | 0 / 1,124 |
| serious Total, serious adverse events | 0 / 1,124 |
Outcome results
Primary
Demographics of Tobacco and Nicotine-containing Product Users
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'.
Time frame: IQOS users at enrollment
Population: IQOS users at enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 50-59 years of age | 50 Participants |
| IQOS Users: 3 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 30-39 years of age | 102 Participants |
| IQOS Users: 3 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 60-69 years of age | 4 Participants |
| IQOS Users: 3 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 20-29 years of age | 20 Participants |
| IQOS Users: 3 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 40-49 years of age | 128 Participants |
| IQOS Users: 3 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | Male | 263 Participants |
| IQOS Users: 3 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 70-79 years of age | 1 Participants |
| IQOS Users: 6 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 70-79 years of age | 0 Participants |
| IQOS Users: 6 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 40-49 years of age | 18 Participants |
| IQOS Users: 6 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 30-39 years of age | 18 Participants |
| IQOS Users: 6 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 50-59 years of age | 11 Participants |
| IQOS Users: 6 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | Male | 44 Participants |
| IQOS Users: 6 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 20-29 years of age | 4 Participants |
| IQOS Users: 6 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 60-69 years of age | 1 Participants |
| IQOS Users: 9 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 60-69 years of age | 0 Participants |
| IQOS Users: 9 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 40-49 years of age | 25 Participants |
| IQOS Users: 9 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 20-29 years of age | 3 Participants |
| IQOS Users: 9 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 50-59 years of age | 15 Participants |
| IQOS Users: 9 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 30-39 years of age | 21 Participants |
| IQOS Users: 9 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | Male | 57 Participants |
| IQOS Users: 9 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 70-79 years of age | 0 Participants |
| IQOS Users: 12 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 60-69 years of age | 2 Participants |
| IQOS Users: 12 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | Male | 22 Participants |
| IQOS Users: 12 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 70-79 years of age | 0 Participants |
| IQOS Users: 12 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 20-29 years of age | 1 Participants |
| IQOS Users: 12 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 50-59 years of age | 2 Participants |
| IQOS Users: 12 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 30-39 years of age | 9 Participants |
| IQOS Users: 12 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 40-49 years of age | 11 Participants |
| IQOS Users: 15 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 20-29 years of age | 1 Participants |
| IQOS Users: 15 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | Male | 10 Participants |
| IQOS Users: 15 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 30-39 years of age | 1 Participants |
| IQOS Users: 15 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 40-49 years of age | 7 Participants |
| IQOS Users: 15 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 50-59 years of age | 3 Participants |
| IQOS Users: 15 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 60-69 years of age | 0 Participants |
| IQOS Users: 15 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 70-79 years of age | 0 Participants |
| IQOS Users: 18 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 30-39 years of age | 0 Participants |
| IQOS Users: 18 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 20-29 years of age | 0 Participants |
| IQOS Users: 18 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 40-49 years of age | 0 Participants |
| IQOS Users: 18 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | Male | 1 Participants |
| IQOS Users: 18 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 70-79 years of age | 0 Participants |
| IQOS Users: 18 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 60-69 years of age | 0 Participants |
| IQOS Users: 18 Months IQOS Use | Demographics of Tobacco and Nicotine-containing Product Users | 50-59 years of age | 1 Participants |
| CC Smokers | Demographics of Tobacco and Nicotine-containing Product Users | 60-69 years of age | 0 Participants |
| CC Smokers | Demographics of Tobacco and Nicotine-containing Product Users | 30-39 years of age | 11 Participants |
| CC Smokers | Demographics of Tobacco and Nicotine-containing Product Users | 20-29 years of age | 4 Participants |
| CC Smokers | Demographics of Tobacco and Nicotine-containing Product Users | 50-59 years of age | 12 Participants |
| CC Smokers | Demographics of Tobacco and Nicotine-containing Product Users | Male | 37 Participants |
| CC Smokers | Demographics of Tobacco and Nicotine-containing Product Users | 40-49 years of age | 11 Participants |
| CC Smokers | Demographics of Tobacco and Nicotine-containing Product Users | 70-79 years of age | 1 Participants |
Primary
Product Consumption
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.
Time frame: CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time
Population: CC smokers: at enrollment, IQOS users: 3-18 months IQOS use time
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Product Consumption | Mean number of Heatsticks used per day | 13.3 number of consumption per day | Standard Deviation 8.85 |
| IQOS Users: 3 Months IQOS Use | Product Consumption | Mean number/times of OTP used per day | 1.8 number of consumption per day | Standard Deviation 6 |
| IQOS Users: 3 Months IQOS Use | Product Consumption | Mean number of cigarettes smoked per day | 4.0 number of consumption per day | Standard Deviation 7.72 |
| IQOS Users: 6 Months IQOS Use | Product Consumption | Mean number/times of OTP used per day | 2.0 number of consumption per day | Standard Deviation 5.41 |
| IQOS Users: 6 Months IQOS Use | Product Consumption | Mean number of Heatsticks used per day | 13.2 number of consumption per day | Standard Deviation 7.75 |
| IQOS Users: 6 Months IQOS Use | Product Consumption | Mean number of cigarettes smoked per day | 3.8 number of consumption per day | Standard Deviation 6.68 |
| IQOS Users: 9 Months IQOS Use | Product Consumption | Mean number/times of OTP used per day | 2.6 number of consumption per day | Standard Deviation 7.97 |
| IQOS Users: 9 Months IQOS Use | Product Consumption | Mean number of cigarettes smoked per day | 4.6 number of consumption per day | Standard Deviation 7.99 |
| IQOS Users: 9 Months IQOS Use | Product Consumption | Mean number of Heatsticks used per day | 13.3 number of consumption per day | Standard Deviation 8.52 |
| IQOS Users: 12 Months IQOS Use | Product Consumption | Mean number/times of OTP used per day | 2.5 number of consumption per day | Standard Deviation 7.41 |
| IQOS Users: 12 Months IQOS Use | Product Consumption | Mean number of Heatsticks used per day | 13.8 number of consumption per day | Standard Deviation 8.68 |
| IQOS Users: 12 Months IQOS Use | Product Consumption | Mean number of cigarettes smoked per day | 4.4 number of consumption per day | Standard Deviation 8.12 |
| IQOS Users: 15 Months IQOS Use | Product Consumption | Mean number of cigarettes smoked per day | 5.1 number of consumption per day | Standard Deviation 8.8 |
| IQOS Users: 15 Months IQOS Use | Product Consumption | Mean number/times of OTP used per day | 2.3 number of consumption per day | Standard Deviation 6.33 |
| IQOS Users: 15 Months IQOS Use | Product Consumption | Mean number of Heatsticks used per day | 12.7 number of consumption per day | Standard Deviation 8.61 |
| IQOS Users: 18 Months IQOS Use | Product Consumption | Mean number of Heatsticks used per day | 12.6 number of consumption per day | Standard Deviation 8.69 |
| IQOS Users: 18 Months IQOS Use | Product Consumption | Mean number of cigarettes smoked per day | 4.0 number of consumption per day | Standard Deviation 8.06 |
| IQOS Users: 18 Months IQOS Use | Product Consumption | Mean number/times of OTP used per day | 2.5 number of consumption per day | Standard Deviation 5.84 |
| CC Smokers | Product Consumption | Mean number of Heatsticks used per day | 0.2 number of consumption per day | Standard Deviation 1.93 |
| CC Smokers | Product Consumption | Mean number of cigarettes smoked per day | 15.8 number of consumption per day | Standard Deviation 9.43 |
| CC Smokers | Product Consumption | Mean number/times of OTP used per day | 0.5 number of consumption per day | Standard Deviation 2.18 |
Primary
Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration
To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years.
Time frame: From enrollment up to 15 months follow-up
Population: CC smokers who started to use IQOS during follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration | 9.8 years | Standard Deviation 11.47 |
Primary
Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity
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.
Time frame: From enrollment up to 15 months follow-up
Population: CC smokers who started to use IQOS during follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity | 13.4 pack years | Standard Deviation 7.14 |
Primary
Product Use Patterns
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'.
Time frame: IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up
Population: IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | Other | 4 Participants |
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | missing | 4 Participants |
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 1 Participants |
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 2 Participants |
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | Non-user/Smoker | 0 Participants |
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 6 Participants |
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 45 Participants |
| IQOS Users: 3 Months IQOS Use | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 8 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 29 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | Non-user/Smoker | 3 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 133 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 15 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | missing | 28 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 16 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 4 Participants |
| IQOS Users: 6 Months IQOS Use | Product Use Patterns | Other | 14 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 8 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 228 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | Other | 26 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 22 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 46 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | Non-user/Smoker | 1 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | missing | 47 Participants |
| IQOS Users: 9 Months IQOS Use | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 44 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 4 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 182 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 36 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | Other | 23 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 30 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 13 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | missing | 23 Participants |
| IQOS Users: 12 Months IQOS Use | Product Use Patterns | Non-user/Smoker | 1 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 15 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 3 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 94 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | Other | 10 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | missing | 0 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | Non-user/Smoker | 2 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 26 Participants |
| IQOS Users: 15 Months IQOS Use | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 11 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 1 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 15 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 12 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | missing | 0 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 47 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | Other | 3 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | Non-user/Smoker | 2 Participants |
| IQOS Users: 18 Months IQOS Use | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 4 Participants |
| CC Smokers | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 430 Participants |
| CC Smokers | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 2 Participants |
| CC Smokers | Product Use Patterns | Other | 3 Participants |
| CC Smokers | Product Use Patterns | Non-user/Smoker | 7 Participants |
| CC Smokers | Product Use Patterns | missing | 65 Participants |
| CC Smokers | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 2 Participants |
| CC Smokers | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 16 Participants |
| CC Smokers | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 0 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 2 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 8 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 204 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 1 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 7 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | Non-user/Smoker | 3 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | Other | 3 Participants |
| CC Smokers After 3 Months Follow-up | Product Use Patterns | missing | 0 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | Other | 1 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | Non-user/Smoker | 5 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | missing | 0 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 0 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 91 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 1 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 6 Participants |
| CC Smokers After 6 Months Follow-up | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 3 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 2 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | Non-user/Smoker | 0 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 0 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 0 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 0 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 10 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | Other | 0 Participants |
| CC Smokers After 9 Months Follow-up | Product Use Patterns | missing | 0 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 0 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | missing | 0 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | Non-user/Smoker | 0 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 1 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | Other | 0 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 3 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 0 Participants |
| CC Smokers After 12 Months Follow-up | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 0 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | Mixed CC-OTP (CC and OTP use in 30% to 70%) | 0 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%) | 0 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | Mixed IQOS-CC (IQOS and CC use in 30% to 70%) | 0 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | Non-user/Smoker | 0 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | Primarily CC (≥70% consumption of CC ) | 1 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | Primarily IQOS (≥70% consumption of IQOS) | 0 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | Other | 0 Participants |
| CC Smokers After 15 Months Follow-up | Product Use Patterns | missing | 0 Participants |
Primary
Rate of Product Use
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.
Time frame: IQOS users: 3-18 months IQOS use time
Population: IQOS users: 3-18 months IQOS use time
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Rate of Product Use | %IQOS | 75.3 percentage | Standard Deviation 35.53 |
| IQOS Users: 3 Months IQOS Use | Rate of Product Use | %OTP | 7.2 percentage | Standard Deviation 21.42 |
| IQOS Users: 3 Months IQOS Use | Rate of Product Use | % CC | 17.5 percentage | Standard Deviation 29 |
| IQOS Users: 6 Months IQOS Use | Rate of Product Use | %OTP | 9.3 percentage | Standard Deviation 22.84 |
| IQOS Users: 6 Months IQOS Use | Rate of Product Use | %IQOS | 73.7 percentage | Standard Deviation 33.62 |
| IQOS Users: 6 Months IQOS Use | Rate of Product Use | % CC | 17.0 percentage | Standard Deviation 27.54 |
| IQOS Users: 9 Months IQOS Use | Rate of Product Use | % CC | 19.6 percentage | Standard Deviation 31.18 |
| IQOS Users: 9 Months IQOS Use | Rate of Product Use | %OTP | 9.5 percentage | Standard Deviation 23.33 |
| IQOS Users: 9 Months IQOS Use | Rate of Product Use | %IQOS | 70.9 percentage | Standard Deviation 36.53 |
| IQOS Users: 12 Months IQOS Use | Rate of Product Use | % CC | 18.2 percentage | Standard Deviation 30.34 |
| IQOS Users: 12 Months IQOS Use | Rate of Product Use | %IQOS | 72.0 percentage | Standard Deviation 36.83 |
| IQOS Users: 12 Months IQOS Use | Rate of Product Use | %OTP | 9.8 percentage | Standard Deviation 24.89 |
| IQOS Users: 15 Months IQOS Use | Rate of Product Use | %IQOS | 68.5 percentage | Standard Deviation 38.81 |
| IQOS Users: 15 Months IQOS Use | Rate of Product Use | % CC | 21.7 percentage | Standard Deviation 34.23 |
| IQOS Users: 15 Months IQOS Use | Rate of Product Use | %OTP | 2.3 percentage | Standard Deviation 6.33 |
| IQOS Users: 18 Months IQOS Use | Rate of Product Use | %OTP | 2.5 percentage | Standard Deviation 5.84 |
| IQOS Users: 18 Months IQOS Use | Rate of Product Use | % CC | 19.2 percentage | Standard Deviation 33.51 |
| IQOS Users: 18 Months IQOS Use | Rate of Product Use | %IQOS | 68.9 percentage | Standard Deviation 37.8 |
Primary
Smoking History (Duration)
To record the smoking history (duration) in CC smokers and IQOS users, measured in years.
Time frame: At enrollment
Population: CC smokers and IQOS users at enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Smoking History (Duration) | 15.2 years | Standard Deviation 11.84 |
| IQOS Users: 6 Months IQOS Use | Smoking History (Duration) | 12.0 years | Standard Deviation 13.65 |
Primary
Smoking History (Intensity)
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.
Time frame: At enrollment
Population: CC smokers and IQOS users at enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQOS Users: 3 Months IQOS Use | Smoking History (Intensity) | 17.4 pack years | Standard Deviation 9.12 |
| IQOS Users: 6 Months IQOS Use | Smoking History (Intensity) | 17.0 pack years | Standard Deviation 10 |
Primary
Tobacco and Nicotine-containing Products Cessation
To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users
Time frame: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up
Population: IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IQOS Users: 3 Months IQOS Use | Tobacco and Nicotine-containing Products Cessation | 5 Participants |
| IQOS Users: 6 Months IQOS Use | Tobacco and Nicotine-containing Products Cessation | 15 Participants |