Viewing Study NCT03020667

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Ignite Creation Date: 2025-12-25 @ 12:37 AM
Ignite Modification Date: 2026-03-22 @ 3:32 AM
Study NCT ID: NCT03020667
Status: TERMINATED
Last Update Posted: 2024-09-19
First Post: 2016-11-17
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Japanese Post-Market Cohort Study
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uwatoko.clinic@gmail.com', 'phone': '+81-52-991-4602', 'title': 'Kunihiko Uwatoko, MD', 'organization': 'Uwatoko Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to study termination leading to a shortened follow-up period and a smaller sample size, only 7 outcome measures could be assessed and the other outcome measures originally planned were either unattainable or uninformative.'}}, 'adverseEventsModule': {'timeFrame': '15 Months', 'description': "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.", 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All subjects that participated in the study.', 'otherNumAtRisk': 1124, 'deathsNumAtRisk': 1124, 'otherNumAffected': 0, 'seriousNumAtRisk': 1124, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Product Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '375', 'groupId': 'OG002'}, {'value': '289', 'groupId': 'OG003'}, {'value': '161', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}, {'value': '460', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS Users: 3 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG001', 'title': 'IQOS Users: 6 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG002', 'title': 'IQOS Users: 9 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG003', 'title': 'IQOS Users: 12 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG004', 'title': 'IQOS Users: 15 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG005', 'title': 'IQOS Users: 18 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG006', 'title': 'CC Smokers', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}], 'classes': [{'title': 'Mean number of cigarettes smoked per day', 'categories': [{'measurements': [{'value': '4.0', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '6.68', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '7.99', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '8.12', 'groupId': 'OG003'}, {'value': '5.1', 'spread': '8.80', 'groupId': 'OG004'}, {'value': '4.0', 'spread': '8.06', 'groupId': 'OG005'}, {'value': '15.8', 'spread': '9.43', 'groupId': 'OG006'}]}]}, {'title': 'Mean number of Heatsticks used per day', 'categories': [{'measurements': [{'value': '13.3', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '7.75', 'groupId': 'OG001'}, {'value': '13.3', 'spread': '8.52', 'groupId': 'OG002'}, {'value': '13.8', 'spread': '8.68', 'groupId': 'OG003'}, {'value': '12.7', 'spread': '8.61', 'groupId': 'OG004'}, {'value': '12.6', 'spread': '8.69', 'groupId': 'OG005'}, {'value': '0.2', 'spread': '1.93', 'groupId': 'OG006'}]}]}, {'title': 'Mean number/times of OTP used per day', 'categories': [{'measurements': [{'value': '1.8', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '5.41', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '7.97', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '7.41', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '6.33', 'groupId': 'OG004'}, {'value': '2.5', 'spread': '5.84', 'groupId': 'OG005'}, {'value': '0.5', 'spread': '2.18', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time', 'description': '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.', 'unitOfMeasure': 'number of consumption per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CC smokers: at enrollment, IQOS users: 3-18 months IQOS use time'}, {'type': 'PRIMARY', 'title': 'Product Use Patterns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '419', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}, {'value': '525', 'groupId': 'OG006'}, {'value': '215', 'groupId': 'OG007'}, {'value': '107', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS Users: 3 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG001', 'title': 'IQOS Users: 6 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG002', 'title': 'IQOS Users: 9 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG003', 'title': 'IQOS Users: 12 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG004', 'title': 'IQOS Users: 15 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG005', 'title': 'IQOS Users: 18 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG006', 'title': 'CC Smokers Enrollment', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}, {'id': 'OG007', 'title': 'CC Smokers After 3 Months Follow-up', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}, {'id': 'OG008', 'title': 'CC Smokers After 6 Months Follow-up', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}, {'id': 'OG009', 'title': 'CC Smokers After 9 Months Follow-up', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}, {'id': 'OG010', 'title': 'CC Smokers After 12 Months Follow-up', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}, {'id': 'OG011', 'title': 'CC Smokers After 15 Months Follow-up', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}], 'classes': [{'title': 'Primarily IQOS (≥70% consumption of IQOS)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Primarily CC (≥70% consumption of CC )', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '430', 'groupId': 'OG006'}, {'value': '204', 'groupId': 'OG007'}, {'value': '91', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Mixed IQOS-CC (IQOS and CC use in 30% to 70%)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Mixed IQOS-OTP (IQOS and OTP use in 30% to 70%)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Mixed CC-OTP (CC and OTP use in 30% to 70%)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Non-user/Smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '65', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up', 'description': "To describe product use patterns in CC smokers and IQOS users by product use categories.\n\nPrimarily 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'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up'}, {'type': 'PRIMARY', 'title': 'Rate of Product Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '419', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS Users: 3 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG001', 'title': 'IQOS Users: 6 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG002', 'title': 'IQOS Users: 9 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG003', 'title': 'IQOS Users: 12 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG004', 'title': 'IQOS Users: 15 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG005', 'title': 'IQOS Users: 18 Months IQOS Use', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}], 'classes': [{'title': '% CC', 'categories': [{'measurements': [{'value': '17.5', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '27.54', 'groupId': 'OG001'}, {'value': '19.6', 'spread': '31.18', 'groupId': 'OG002'}, {'value': '18.2', 'spread': '30.34', 'groupId': 'OG003'}, {'value': '21.7', 'spread': '34.23', 'groupId': 'OG004'}, {'value': '19.2', 'spread': '33.51', 'groupId': 'OG005'}]}]}, {'title': '%OTP', 'categories': [{'measurements': [{'value': '7.2', 'spread': '21.42', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '22.84', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '23.33', 'groupId': 'OG002'}, {'value': '9.8', 'spread': '24.89', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '6.33', 'groupId': 'OG004'}, {'value': '2.5', 'spread': '5.84', 'groupId': 'OG005'}]}]}, {'title': '%IQOS', 'categories': [{'measurements': [{'value': '75.3', 'spread': '35.53', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '33.62', 'groupId': 'OG001'}, {'value': '70.9', 'spread': '36.53', 'groupId': 'OG002'}, {'value': '72.0', 'spread': '36.83', 'groupId': 'OG003'}, {'value': '68.5', 'spread': '38.81', 'groupId': 'OG004'}, {'value': '68.9', 'spread': '37.80', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IQOS users: 3-18 months IQOS use time', 'description': 'To measure the percentage of product use in IQOS users based on IQOS use time.\n\n* IQOSi = percentage of IQOS use at time point i,\n* CCi = percentage of CC use at time point i,\n* OTPi = percentage of other tobacco products (OTP) use at time point i.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IQOS users: 3-18 months IQOS use time'}, {'type': 'PRIMARY', 'title': 'Tobacco and Nicotine-containing Products Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS Users', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG001', 'title': 'CC Smokers', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up', 'description': 'To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up'}, {'type': 'PRIMARY', 'title': 'Demographics of Tobacco and Nicotine-containing Product Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '39', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Primarily IQOS', 'description': '≥70% consumption of IQOS'}, {'id': 'OG001', 'title': 'Primarily CC', 'description': '≥70% consumption of CC'}, {'id': 'OG002', 'title': 'Mixed IQOS-CC', 'description': 'Consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%)'}, {'id': 'OG003', 'title': 'Mixed IQOS-OTP', 'description': 'Consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%)'}, {'id': 'OG004', 'title': 'Mixed CC-OTP', 'description': 'Consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%)'}, {'id': 'OG005', 'title': 'Non-use', 'description': 'Total consumption of all products=0'}, {'id': 'OG006', 'title': 'Other', 'description': "Does not fit in any of the categories and no 'missing'"}], 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}]}]}, {'title': '20-29 years of age', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': '30-39 years of age', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}]}, {'title': '40-49 years of age', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}]}, {'title': '50-59 years of age', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}]}, {'title': '60-69 years of age', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': '70-79 years of age', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'IQOS users at enrollment', 'description': "To describe the demographics characteristics of IQOS users by product use category:\n\nPrimarily 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'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IQOS users at enrollment'}, {'type': 'PRIMARY', 'title': 'Smoking History (Duration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS Users', 'description': 'The criteria defining an "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG001', 'title': 'CC Smokers', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'spread': '11.84', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '13.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At enrollment', 'description': 'To record the smoking history (duration) in CC smokers and IQOS users, measured in years.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CC smokers and IQOS users at enrollment'}, {'type': 'PRIMARY', 'title': 'Smoking History (Intensity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQOS Users', 'description': 'The criteria defining an "IQOS user" are listed in the section "Eligibility".'}, {'id': 'OG001', 'title': 'CC Smokers', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '10.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At enrollment', 'description': '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.', 'unitOfMeasure': 'pack years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CC smokers and IQOS users at enrollment'}, {'type': 'PRIMARY', 'title': 'Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CC Smokers', 'description': 'Subjects enrolled as CC smokers who started to use IQOS during follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '11.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment up to 15 months follow-up', 'description': 'To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CC smokers who started to use IQOS during follow-up'}, {'type': 'PRIMARY', 'title': 'Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CC Smokers', 'description': 'Subjects enrolled as CC smokers who started to use IQOS during follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '7.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment up to 15 months follow-up', 'description': '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.', 'unitOfMeasure': 'pack years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CC smokers who started to use IQOS during follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CC Smokers', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}, {'id': 'FG001', 'title': 'IQOS Users: 3 Months IQOS Use Time', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'FG002', 'title': 'IQOS Users: 6 Months IQOS Use Time', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'FG003', 'title': 'IQOS Users: 9 Months IQOS Use Time', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'FG004', 'title': 'IQOS Users 12 Months IQOS Use Time', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'FG005', 'title': 'IQOS Users 15 Months IQOS Use Time', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}], 'periods': [{'title': 'At Month 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '525'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'At Month 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'At Month 9', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '264'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '264'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'At Month 12', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '264'}, {'groupId': 'FG004', 'numSubjects': '73'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '134'}, {'groupId': 'FG004', 'numSubjects': '73'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '130'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'At Month 15', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '134'}, {'groupId': 'FG004', 'numSubjects': '73'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '98'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '63'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'At Month 18', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '98'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.\n\nNote: only data collected of wave 1 participants was analyzed.', 'preAssignmentDetails': 'CC smokers: based on the date of enrollment. IQOS users: based on date of initiation of IQOS use (IQOS use time).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'BG000'}, {'value': '599', 'groupId': 'BG001'}, {'value': '1124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CC Smokers', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}, {'id': 'BG001', 'title': 'IQOS Users', 'description': 'The criteria defining a "IQOS user" are listed in the section "Eligibility".'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '9.16', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '8.67', 'groupId': 'BG001'}, {'value': '45.0', 'spread': '9.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '396', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '907', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '525', 'groupId': 'BG000'}, {'value': '599', 'groupId': 'BG001'}, {'value': '1124', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '525', 'groupId': 'BG000'}, {'value': '599', 'groupId': 'BG001'}, {'value': '1124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Adult Japanese CC smokers or IQOS users'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-13', 'size': 5714005, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-27T09:06', 'hasProtocol': True}, {'date': '2018-04-27', 'size': 8307103, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-27T09:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1124}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was terminated due to excessive attrition rates.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2016-11-17', 'resultsFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-07', 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Product Consumption', 'timeFrame': 'CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time', 'description': '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.'}, {'measure': 'Product Use Patterns', 'timeFrame': 'IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up', 'description': "To describe product use patterns in CC smokers and IQOS users by product use categories.\n\nPrimarily 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'."}, {'measure': 'Rate of Product Use', 'timeFrame': 'IQOS users: 3-18 months IQOS use time', 'description': 'To measure the percentage of product use in IQOS users based on IQOS use time.\n\n* IQOSi = percentage of IQOS use at time point i,\n* CCi = percentage of CC use at time point i,\n* OTPi = percentage of other tobacco products (OTP) use at time point i.'}, {'measure': 'Tobacco and Nicotine-containing Products Cessation', 'timeFrame': 'IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up', 'description': 'To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users'}, {'measure': 'Demographics of Tobacco and Nicotine-containing Product Users', 'timeFrame': 'IQOS users at enrollment', 'description': "To describe the demographics characteristics of IQOS users by product use category:\n\nPrimarily 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'."}, {'measure': 'Smoking History (Duration)', 'timeFrame': 'At enrollment', 'description': 'To record the smoking history (duration) in CC smokers and IQOS users, measured in years.'}, {'measure': 'Smoking History (Intensity)', 'timeFrame': 'At enrollment', 'description': '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.'}, {'measure': 'Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration', 'timeFrame': 'From enrollment up to 15 months follow-up', 'description': 'To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years.'}, {'measure': 'Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity', 'timeFrame': 'From enrollment up to 15 months follow-up', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cigarette', 'IQOS', 'Nicotine-containing product', 'Tobacco'], 'conditions': ['Smoking', 'Tobacco Product']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "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.\n\nFor 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).\n\nThe 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.\n\nAs 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (female or male) Japanese IQOS users and CC smokers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult tobacco users in Japan (at least 20 years of age)\n* The participant is Japanese\n* Participant is able to understand the information provided in the Informed Consent form (ICF)\n* Signed ICF\n* Willing to participate in the study and has access to the internet\n* For IQOS users:\n\n * Is currently using IQOS with HeatSticks\n * Has used at least 100 HeatSticks with IQOS in their lifetime, and\n * Has used IQOS with HeatSticks for 2 months or more\n* For CC smokers:\n\n * Is currently using CC\n * Is not currently using IQOS with HeatSticks, and\n * Has used at least 100 CC in their lifetime\n\nExclusion Criteria:\n\n* Tobacco industry employees\n* Employed by the Sponsor, CRO or Clinical Site\n* For IQOS users:\n\n * More than 12 months of IQOS use'}, 'identificationModule': {'nctId': 'NCT03020667', 'briefTitle': 'Japanese Post-Market Cohort Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'An Observational Cohort Study in Japan to Assess the Patterns of Product Use and Changes in Health Outcomes Associated With the Use of HeatSticks With the IQOS Tobacco Heating System', 'orgStudyIdInfo': {'id': 'P1-PMC-01-JP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IQOS Users', 'description': 'The criteria defining an "IQOS user" are listed in the section "Eligibility".'}, {'label': 'Cigarette (CC) Smokers', 'description': 'The criteria defining a "CC smoker" are listed in the section "Eligibility".'}]}, 'contactsLocationsModule': {'locations': [{'zip': '462-0825', 'city': 'Ōzone', 'state': 'Nagoya', 'country': 'Japan', 'facility': 'Uwatoko Clinic', 'geoPoint': {'lat': 36.13333, 'lon': 140.1}}], 'overallOfficials': [{'name': 'Kunihiko Uwatoko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uwatoko Clinic'}, {'name': 'Pierpaolo Magnani', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}