Smoking Cessation
Conditions
Keywords
smoking cessation, psychiatric disease, cardiovascular events
Brief summary
Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.
Detailed description
This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.
Interventions
DRUGplacebo
All dosing to have taken place per study A3051123
All dosing to have taken place per study A3051123
All dosing to have taken place per study A3051123
All dosing to have taken place per study A3051123
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects will be eligible if they were randomized to study A3051123.
Exclusion criteria
* Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to MACE Until the End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio. |
| Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). |
| Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. |
| Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days. | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio. |
| Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. | This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. |
| Incidence of MACE Assessed Until End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. |
| Incidence of MACE+ Assessed Until End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. |
| Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Denmark, Finland, Germany, Mexico, New Zealand, Russia, Slovakia, South Africa, Spain, United States
Participant flow
Recruitment details
Of the 6293 participants who completed the parent study NCT01456936 as per protocol, a total of 4595 participants enrolled into this study NCT01574703 from 132 centers in 16 countries.
Pre-assignment details
This is a non-treatment extension study of parent study NCT01456936. No study drug was provided in this extension phase. However, cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline(N=2016), bupropion(N=2006),NRT(N=2022), or placebo(N=2014) in a triple-dummy design were analyzed in this study.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study. | 1,192 |
| Bupropion This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study. | 1,166 |
| NRT Patch This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study. | 1,116 |
| Placebo This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study. | 1,121 |
| Total | 4,595 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 | 1 |
| Overall Study | Death | 2 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 43 | 41 | 46 | 35 |
| Overall Study | Met Withdrawal Criteria | 0 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Unspecified Reason | 27 | 15 | 20 | 16 |
| Overall Study | Withdrawal by Subject | 53 | 52 | 36 | 61 |
Baseline characteristics
| Characteristic | Varenicline | Bupropion | NRT Patch | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.1 Years STANDARD_DEVIATION 12.2 | 47.7 Years STANDARD_DEVIATION 12.5 | 48.3 Years STANDARD_DEVIATION 11.9 | 47.5 Years STANDARD_DEVIATION 12.2 | 47.9 Years STANDARD_DEVIATION 12.2 |
| Gender Female | 659 Participants | 648 Participants | 623 Participants | 621 Participants | 2551 Participants |
| Gender Male | 533 Participants | 518 Participants | 493 Participants | 500 Participants | 2044 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 165 / 1,192 | 160 / 1,166 | 116 / 1,116 | 143 / 1,121 |
| serious Total, serious adverse events | 34 / 1,192 | 39 / 1,166 | 43 / 1,116 | 41 / 1,121 |
Outcome results
Primary
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.
Time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.29 Unitless |
| Bupropion | Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.50 Unitless |
| NRT Patch | Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.29 Unitless |
| Placebo | Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | NA Unitless |
Comparison: Statistical analysis for overall treatment comparison.p-value: 0.37Log Rank
Secondary
Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
Time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.25 percentage of participants |
| Bupropion | Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.20 percentage of participants |
| NRT Patch | Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.10 percentage of participants |
| Placebo | Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.25 percentage of participants |
Comparison: Statistical analysis between Varenicline and Bupropion.p-value: 0.968795% CI: [-3.48, 3.34]Regression, Logistic
Comparison: Statistical analysis between Varenicline and NRT patch.p-value: 0.790595% CI: [-3.58, 4.7]Regression, Logistic
Comparison: Statistical analysis between Varenicline and Placebo.p-value: 0.896295% CI: [-3.36, 2.94]Regression, Logistic
Comparison: Statistical analysis between Bupropion and NRT patch.p-value: 0.776795% CI: [-3.72, 4.98]Regression, Logistic
Comparison: Statistical analysis between Bupropion and Placebo.p-value: 0.92695% CI: [-3.13, 2.85]Regression, Logistic
Comparison: Statistical analysis between NRT patch and Placebo.p-value: 0.711395% CI: [-4.85, 3.31]Regression, Logistic
Secondary
Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).
Time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.05 percentage of participants |
| Bupropion | Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.10 percentage of participants |
| NRT Patch | Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.05 percentage of participants |
| Placebo | Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | 0.20 percentage of participants |
Comparison: Statistical analysis between Varenicline and Bupropion.p-value: 0.837595% CI: [-5.22, 4.23]Regression, Logistic
Comparison: Statistical analysis between Varenicline and NRT patch.p-value: 0.97895% CI: [-5.2, 5.05]Regression, Logistic
Comparison: Statistical analysis between Varenicline and Placebo.p-value: 0.614295% CI: [-5.54, 3.27]Regression, Logistic
Comparison: Statistical analysis between Bupropion and NRT patch.p-value: 0.860295% CI: [-4.28, 5.13]Regression, Logistic
Comparison: Statistical analysis between Bupropion and Placebo.p-value: 0.721795% CI: [-4.15, 2.88]Regression, Logistic
Comparison: Statistical analysis between NRT patch and Placebo.p-value: 0.632295% CI: [-5.41, 3.28]Regression, Logistic
Secondary
Incidence of MACE Assessed Until End of Study NCT01574703.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.
Time frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Incidence of MACE Assessed Until End of Study NCT01574703. | 0.15 percentage of participants |
| Bupropion | Incidence of MACE Assessed Until End of Study NCT01574703. | 0.45 percentage of participants |
| NRT Patch | Incidence of MACE Assessed Until End of Study NCT01574703. | 0.30 percentage of participants |
| Placebo | Incidence of MACE Assessed Until End of Study NCT01574703. | 0.40 percentage of participants |
Comparison: Statistical analysis between Varenicline and Bupropion.p-value: 0.644195% CI: [-4.78, 2.96]Regression, Logistic
Comparison: Statistical analysis between Varenicline and NRT patch.p-value: 0.732795% CI: [-4.63, 3.26]Regression, Logistic
Comparison: Statistical analysis between Varenicline and Placebo.p-value: 0.610995% CI: [-4.8, 2.82]Regression, Logistic
Comparison: Statistical analysis between Bupropion and NRT patch.p-value: 0.870795% CI: [-2.48, 2.93]Regression, Logistic
Comparison: Statistical analysis between Bupropion and Placebo.p-value: 0.953195% CI: [-2.63, 2.48]Regression, Logistic
Comparison: Statistical analysis between NRT patch and Placebo.p-value: 0.826295% CI: [-2.99, 2.39]Regression, Logistic
Secondary
Incidence of MACE+ Assessed Until End of Study NCT01574703.
This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
Time frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Incidence of MACE+ Assessed Until End of Study NCT01574703. | 0.50 percentage of participants |
| Bupropion | Incidence of MACE+ Assessed Until End of Study NCT01574703. | 0.75 percentage of participants |
| NRT Patch | Incidence of MACE+ Assessed Until End of Study NCT01574703. | 0.49 percentage of participants |
| Placebo | Incidence of MACE+ Assessed Until End of Study NCT01574703. | 0.60 percentage of participants |
Comparison: Statistical analysis between Varenicline and Bupropion.p-value: 0.610595% CI: [-2.84, 1.67]Regression, Logistic
Comparison: Statistical analysis between Varenicline and NRT patch.p-value: 0.789595% CI: [-2.65, 2.01]Regression, Logistic
Comparison: Statistical analysis between Varenicline and Placebo.p-value: 0.680495% CI: [-2.75, 1.8]Regression, Logistic
Comparison: Statistical analysis between Bupropion and NRT patch.p-value: 0.812795% CI: [-1.95, 2.49]Regression, Logistic
Comparison: Statistical analysis between Bupropion and Placebo.p-value: 0.921895% CI: [-2.04, 2.25]Regression, Logistic
Comparison: Statistical analysis between NRT patch and Placebo.p-value: 0.884195% CI: [-2.32, 2]Regression, Logistic
Secondary
Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.
Time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.05 percentage of participants |
| Bupropion | Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.10 percentage of participants |
| NRT Patch | Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.10 percentage of participants |
| Placebo | Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.20 percentage of participants |
Comparison: Statistical analysis between Varenicline and Bupropion.p-value: 0.811795% CI: [-5.27, 4.13]Regression, Logistic
Comparison: Statistical analysis between Varenicline and NRT patch.p-value: 0.730395% CI: [-5.21, 3.65]Regression, Logistic
Comparison: Statistical analysis between Varenicline and Placebo.p-value: 0.594695% CI: [-5.6, 3.21]Regression, Logistic
Comparison: Statistical analysis between Bupropion and NRT patch.p-value: 0.9295% CI: [-4.27, 3.85]Regression, Logistic
Comparison: Statistical analysis between Bupropion and Placebo.p-value: 0.723695% CI: [-4.09, 2.84]Regression, Logistic
Comparison: Statistical analysis between NRT patch and Placebo.p-value: 0.820195% CI: [-4.01, 3.17]Regression, Logistic
Secondary
Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
Time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.25 percentage of participants |
| Bupropion | Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.20 percentage of participants |
| NRT Patch | Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.15 percentage of participants |
| Placebo | Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.35 percentage of participants |
Comparison: Statistical analysis between Varenicline and Bupropion.p-value: 0.893295% CI: [-3.22, 2.81]Regression, Logistic
Comparison: Statistical analysis between Varenicline and NRT patch.p-value: 0.874795% CI: [-3.09, 2.63]Regression, Logistic
Comparison: Statistical analysis between Varenicline and Placebo.p-value: 0.67195% CI: [-3.35, 2.15]Regression, Logistic
Comparison: Statistical analysis between Bupropion and NRT patch.p-value: 0.988695% CI: [-3.32, 3.27]Regression, Logistic
Comparison: Statistical analysis between Bupropion and Placebo.p-value: 0.763195% CI: [-2.92, 2.14]Regression, Logistic
Comparison: Statistical analysis between NRT patch and Placebo.p-value: 0.802295% CI: [-3.23, 2.5]Regression, Logistic
Secondary
Time to MACE Until the End of Study NCT01574703.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.
Time frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Time to MACE Until the End of Study NCT01574703. | 0.39 Unitless |
| Bupropion | Time to MACE Until the End of Study NCT01574703. | 1.09 Unitless |
| NRT Patch | Time to MACE Until the End of Study NCT01574703. | 0.75 Unitless |
| Placebo | Time to MACE Until the End of Study NCT01574703. | NA Unitless |
Comparison: Statistical analysis for overall treatment comparison.p-value: 0.34Log Rank
Secondary
Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.
Time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.
Population: The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.29 Unitless |
| Bupropion | Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.51 Unitless |
| NRT Patch | Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | 0.50 Unitless |
| Placebo | Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | NA Unitless |
Comparison: Statistical analysis for overall treatment comparison.p-value: 0.53Log Rank