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The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
This was a randomized, controlled, open-label, parallel group, multicenter, 9-week study to determine changes in BOE in adult smokers allowed ad libitum use of an OTDN product relative to adult smokers who were not allowed to use an OTDN product. This study was conducted in adult smokers who were considered to be in overall good health. Subjects were randomized to Test (allowed OTDN use) or Control (not allowed OTDN use) groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Continue Smoking | No Intervention | Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks | |
| Group 2: OTDN | Experimental | Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and provided the option to use an OTDN (specifically, VERVE® Discs Blue Mint [VBM-FG2]) also under ad libitum conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral tobacco-derived nicotine product (OTDN) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure. | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 |
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Inclusion Criteria:
Subject must:
Exclusion Criteria:
Subject must not:
This study enrolled adult male and female (no more than 60% of either gender) self-affirmed combustible cigarette smokers
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery S Edmiston, PhD | Altria Client Services LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Daytona Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Covance Evansville Clinical Research Unit |
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Subjects were required to complete an 8 day baseline assessment during which subject cigarette use data was collected using daily interactive voice response system (IVRS) calls and recall of the previous week methods. Three subjects were withdrawn from the study prior to randomization. A total of 154 subjects were randomized in this study; 92 subjects were randomized to the Test Group and 62 subjects were randomized to the Control Group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (ad Libitum VERVE® Discs Blue Mint [VBM-FG2] Use) | Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions. |
| FG001 | Control (no VBM-FG2) | Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test (ad Libitum VBM-FG2) | Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions |
| BG001 | Control (no VBM-FG2) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) | Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure. | Per-protocol population. All Per-Protocol Test and Control subjects were included in the analysis. If a value was missing for any subject at any visit, that subject's value was omitted from the analysis for that visit only. | Posted | Mean | Standard Deviation | percent change from baseline | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.
One-hundred and fifty-seven (157) subjects were included in the Safety Population which included all subjects who tried the test product at least once during the study, including those subjects who participated only in the screening phase. Subjects were queried at each visit for any additional adverse events (AEs) or modifications to existing events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test (ad Libitum VBM-FG2) | Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and were provided the option to use the test product (VBM-FG2 oral discs) also under ad libitum conditions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Edmiston, Functional Director Clinical Research | Altria | 8043352366 | Jeffery.S.Edmiston@altria.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: COV-VER-01-13 Protocol Version 1 | Aug 9, 2013 | Apr 1, 2024 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: COV-VER-01-13 Protocol Version 2 | Aug 20, 2013 | Apr 1, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2013 | Apr 1, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid [S-PMA] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid [S-PMA] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Summary statistics of change from Baseline in number or products used day in each study visit are presented. Values for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented. CPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36. Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure. | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population) | Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Baseline = Visit 3 (Day 8) value Population: Per-Protocol | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question "How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?". Baseline = Visit 2 values. Population: Per-Protocol. | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol) | Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question "Are you planning to quit smoking in the next 30 days?". Baseline = Visit 2 responses. Population: Per-Protocol. | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | Daily during Baseline Period (Day 1 to Day 8) |
| Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol. | Daily during Baseline Period (Day 1 to Day 8) |
| Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary S-phenylmercapturic acid [S-PMA] exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | Daily during Baseline Period (Day 1 to Day 8) |
| Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean blood carboxyhemoglobin [COHb] exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | Daily during Baseline Period (Day 1 to Day 8) |
| Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean exhaled carbon monoxide [CO] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | Daily during Baseline Period (Day 1 to Day 8) |
| Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in product use (Cigarettes Per Day [CPD]), including test product, between two methods for determining CPD during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | Daily during Baseline Period (Day 1 to Day 8) |
| Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Change in cigarette consumption, categorized as 'No change', '<50% reduction', '50% to < 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1). | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
| Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values. | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
| Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1) | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | Summary statistics of average cigarettes smoked per day [CPD] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented. | Day 1 (Visit 2) and Day 8 (Visit 3) |
| Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
| Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
| Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
| Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing'). | Day 1 (Visit 2) and Day 8 (Visit 3) |
| Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | Daily during Baseline Period (Day 1 to Day 8) |
| Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values. | Day 8 (Visit 3) and End of Study (Day 36±1) |
| Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid [S-PMA] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid [S-PMA] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
| Characterization of Subgroups Based on Change From Baseline in Total NNAL | Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented. Baseline = Visit 3 values. | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
| Evansville |
| Indiana |
| 47710 |
| United States |
| Covance Dallas Clinical Research Unit | Dallas | Texas | 75247 | United States |
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Quit Attempts | Quit Attempts and Quitting Intentions Questionnaire - Day 1 was used to determine Quit Attempts | Count of Participants | Participants |
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| Cigarette Consumption per Day | Day 7 IVRS data (or the last available data entered before the Day 8 site visit) were used to derive the Cigarette Consumption per day and it was in the randomization on Day 8 | Count of Participants | Participants |
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| Quit Attempts in previous 6 months | Number of times stopped smoking cigarettes for 24 hours or longer in an attempt to quit in past 6 months | Intent to Treat population. Data was not available for four subjects. | Mean | Standard Deviation | smoking cessations |
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| Number of years smoked since turning 21 years of age | Intent to Treat population. Data was not available for three subjects. | Mean | Standard Deviation | years |
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| Secondary | Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population) | Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Per-protocol population | Posted | Mean | Standard Deviation | ng/g | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population) | Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Per-protocol population | Posted | Mean | Standard Deviation | mg/g | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Per-protocol population | Posted | Mean | Standard Deviation | percent change from baseline | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population) | Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid [S-PMA] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Per-protocol population | Posted | Mean | Standard Deviation | ng/g | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid [S-PMA] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Per-protocol population | Posted | Mean | Standard Deviation | percent change from baseline | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Per-protocol population | Posted | Mean | Standard Deviation | percent saturation of carboxyhemoglobin | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Per-protocol population | Posted | Mean | Standard Deviation | percent change from baseline | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population) | Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Per-protocol population | Posted | Mean | Standard Deviation | ppm | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population) | Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure. | Per-protocol population | Posted | Mean | Standard Deviation | percent change from baseline | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population) | Summary statistics of change from Baseline in number or products used day in each study visit are presented. Values for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 | Per-protocol population | Posted | Mean | Standard Deviation | cigarettes per day | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population) | Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented. CPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36. Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure. | Per-protocol population | Posted | Mean | Standard Deviation | percent change from baseline | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population) | Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Baseline = Visit 3 (Day 8) value Population: Per-Protocol | Per-protocol population | Posted | Mean | Standard Deviation | scores on a scale | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol) | Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question "How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?". Baseline = Visit 2 values. Population: Per-Protocol. | Per-protocol population | Posted | Count of Participants | Participants | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol) | Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question "Are you planning to quit smoking in the next 30 days?". Baseline = Visit 2 responses. Population: Per-Protocol. | Per-protocol population | Posted | Count of Participants | Participants | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population. | Posted | Mean | Standard Deviation | ng/g | Daily during Baseline Period (Day 1 to Day 8) |
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| Secondary | Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol. | The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population. | Posted | Mean | Standard Deviation | mg/g | Daily during Baseline Period (Day 1 to Day 8) |
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| Secondary | Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary S-phenylmercapturic acid [S-PMA] exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population. | Posted | Mean | Standard Deviation | ng/g | Daily during Baseline Period (Day 1 to Day 8) |
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| Secondary | Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean blood carboxyhemoglobin [COHb] exposure between two methods for determining daily product use (Cigarettes Per Day [CPD]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population. | Posted | Mean | Standard Deviation | percent saturation of carboxyhemoglobin | Daily during Baseline Period (Day 1 to Day 8) |
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| Secondary | Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean exhaled carbon monoxide [CO] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population. | Posted | Mean | Standard Deviation | ppm | Daily during Baseline Period (Day 1 to Day 8) |
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| Secondary | Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol) | This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in product use (Cigarettes Per Day [CPD]), including test product, between two methods for determining CPD during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol. | The CPD from Method 1 (Past 7 Day Cigarettes Use Questionnaire) for all subjects in the Per-Protocol population was compared to CPD from Method 2 (7 day average from IVRS) for all subjects in the Per-Protocol population. | Posted | Mean | Standard Deviation | cigarettes per day | Daily during Baseline Period (Day 1 to Day 8) |
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| Secondary | Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption | Change in cigarette consumption, categorized as 'No change', '<50% reduction', '50% to < 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1). | Per-protocol population | Posted | Count of Participants | Participants | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
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| Secondary | Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine) | Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values. | Per-protocol population | Posted | Count of Participants | Participants | Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
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| Secondary | Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions | Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1) | Per-protocol population | Posted | Count of Participants | Participants | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
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| Secondary | Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | Summary statistics of average cigarettes smoked per day [CPD] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented. | Per-protocol population | Posted | Mean | Standard Deviation | cigarettes per day | Day 1 (Visit 2) and Day 8 (Visit 3) |
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| Secondary | Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits | Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | percent saturation of carboxyhemoglobin | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
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| Secondary | Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits | Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | ppm | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
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| Secondary | Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits | Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | ng/g | Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7) |
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| Secondary | Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories | Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing'). | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | cigarettes per day | Day 1 (Visit 2) and Day 8 (Visit 3) |
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| Secondary | Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8 | Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | cigarettes per day | Daily during Baseline Period (Day 1 to Day 8) |
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| Secondary | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values. | Per-Protocol Population | Posted | Median | Inter-Quartile Range | ng/g | Day 8 (Visit 3) and End of Study (Day 36±1) |
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| Secondary | Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories | Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Median | Full Range | ng/g | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
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| Secondary | Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | ng/g | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
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| Secondary | Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | percent change from baseline | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | mg/g | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | percent change from baseline | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid [S-PMA] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | ng/g | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid [S-PMA] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | percent change from baseline | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | percent saturation of carboxyhemoglobin | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | percent change from baseline | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits | Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | ppm | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits | Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', >50% Reduction', '50 to <100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values. | The CPD frequency population (the subjects from the per-protocol population in each cigarette consumption category) was defined by the end of study cigarette use data. This population was then assessed for biomarker data at end of study and previous study visits. The number of samples for biomarkers data may not equal the number of subjects in population (defined by end of study CPD), due to missing visits, missing samples, or missing analytical results. | Posted | Mean | Standard Deviation | percent change from baseline | Day 8 (Visit 3) and Day 36 (Visit 7/End of Study) |
|
|
|
| Secondary | Characterization of Subgroups Based on Change From Baseline in Total NNAL | Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented. Baseline = Visit 3 values. | Per-protocol | Posted | Count of Participants | Participants | Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1) |
|
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 25 |
| 92 |
| EG001 | Control (no VBM-FG2) | Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks | 0 | 62 | 0 | 62 | 7 | 62 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Urogenital trichomoniasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Bladder discomfort | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
Not provided
Not provided
| Unknown or Not Reported |
|
| White |
|
| Other |
|
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL |
| Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL | t-test, 2 sided | 0.8264 | Mean Difference (Net) | -12.2 | 2-Sided | 95 | -122 | 97.5 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents
| Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents | t-test, 2 sided | 0.4251 | Mean Difference (Net) | -1.40 | 2-Sided | 95 | -4.88 | 2.07 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents |
| Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents | t-test, 2 sided | 0.4165 | Mean Difference (Net) | -10.3 | 2-Sided | 95 | -35.4 | 14.7 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: %Change from baseline = study group +visit +study group*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix. | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA
| Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA | t-test, 2 sided | 0.9508 | Mean Difference (Net) | 50.5 | 2-Sided | 95 | -1566 | 1667 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA |
| Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA | t-test, 2 sided | 0.4014 | Mean Difference (Net) | -12.1 | 2-Sided | 95 | -40.4 | 16.3 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: %Change from baseline = study group +visit +study group*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix. | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin
| Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin | t-test, 2 sided | 0.1292 | Mean Difference (Net) | -0.367 | 2-Sided | 95 | -0.843 | 0.108 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin |
| Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin | t-test, 2 sided | 0.1767 | Mean Difference (Net) | -6.76 | 2-Sided | 95 | -16.6 | 3.08 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: %Change from baseline = study group +visit +study group*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix. | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin |
| Visit 6 |
|
| End of Study/Early Termination |
|
Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide
| Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide | t-test, 2 sided | 0.5015 | Mean Difference (Net) | -1.05 | 2-Sided | 95 | -4.12 | 2.03 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide |
| Visit 6 |
|
| End of Study/Early Termination |
|
Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide |
| Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide | t-test, 2 sided | 0.4731 | Mean Difference (Net) | -7.32 | 2-Sided | 95 | -27.4 | 12.8 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: %Change from baseline = study group +visit +study group*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix. | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day |
| Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day | t-test, 2 sided | <0.0001 | Mean Difference (Net) | -3.74 | 2-Sided | 95 | -5.14 | -2.34 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day |
| Visit 5 |
|
|
| Visit 6 |
|
|
| End of Study/Early Termination |
|
|
Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day |
| Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day | t-test, 2 sided | <0.0001 | Mean Difference (Net) | -22.3 | 2-Sided | 95 | -30.4 | -14.1 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: %Change from baseline = study group +visit +study group*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix. | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day |
Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence |
| Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence | t-test, 2 sided | 0.0975 | Mean Difference (Net) | -0.405 | 2-Sided | 95 | -0.886 | 0.0751 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence |
| Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups. Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence | t-test, 2 sided | 0.0643 | Mean Difference (Net) | -8.31 | 2-Sided | 95 | -17.1 | 0.499 | Difference in LS mean percent change between study groups using Mixed Effects Repeated Measures Model 1: Change from baseline=study group + visit + study group*visit + subject + random error, fitted with unstructured covariance matrix | Equivalence | Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups. Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence |
| Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups. Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence | t-test, 2 sided | 0.0517 | Mean Difference (Net) | -8.84 | 2-Sided | 95 | -17.7 | 0.0661 | Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2: Change from baseline= study group + visit + study group*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix | Equivalence | Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups. Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence |
| Decrease |
|
| Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study | Cochran-Mantel-Haenszel | 0.0648 | Probability | 0.0648 | 2-Sided | Equivalence | Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study |
| <50% Reduction |
|
| 50% to < 100% |
|
| 100% Reduction |
|
| Increase |
|
| Reduction |
|
| Increase |
|
| Missing |
|
| Same |
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
|
| No Change |
|
|
| <50% Reduction |
|
|
| 50% to < 100% Reduction |
|
|
| 100% Reduction |
|
|
| Missing |
|
|
| Overall |
|
|
Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study
| Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study | Fisher Exact | 0.2139 | Probability | 0.2139 | 2-Sided | Estimated value is the probability of observed distribution assuming the null hypothesis | Equivalence | Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study |