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Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. (CATS)

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ClinicalTrials.gov Identifier: NCT01574703
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : December 29, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Smoking Cessation
Interventions Drug: placebo
Drug: varenicline tartrate
Drug: bupropion hydrochloride
Drug: Nicotine Replacement Therapy Patch
Enrollment 4595

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.
Arm/Group Title Varenicline Bupropion Nicotine Replacement Therapy (NRT) Patch Placebo
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 1192 1166 1116 1121
Completed 1067 1054 1011 1007
Not Completed 125 112 105 114
Reason Not Completed
Adverse Event             0             2             1             1
Protocol Violation             0             0             0             1
Unspecified Reason             27             15             20             16
Withdrawal by Subject             53             52             36             61
Met Withdrawal Criteria             0             1             1             0
Lost to Follow-up             43             41             46             35
Death             2             1             1             0
Arm/Group Title Varenicline Bupropion NRT Patch Placebo Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 1192 1166 1116 1121 4595
Hide Baseline Analysis Population Description
The term Baseline visit refers to the Baseline (Week 0) visit of the parent study NCT01456936. The safety population included all participants who received at least one dose of study drug in NCT01456936 parent study. The below Baseline characteristics (age, gender) are presented for all participants who entered study NCT01574703.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1192 participants 1166 participants 1116 participants 1121 participants 4595 participants
48.1  (12.2) 47.7  (12.5) 48.3  (11.9) 47.5  (12.2) 47.9  (12.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1192 participants 1166 participants 1116 participants 1121 participants 4595 participants
Female
659
  55.3%
648
  55.6%
623
  55.8%
621
  55.4%
2551
  55.5%
Male
533
  44.7%
518
  44.4%
493
  44.2%
500
  44.6%
2044
  44.5%
1.Primary Outcome
Title Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
Hide Description 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Unitless
0.29
(0.05 to 1.68)
0.50
(0.10 to 2.50)
0.29
(0.05 to 1.70)
NA [1] 
(NA to NA)
[1]
Hazard ratio relative to Placebo.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion, NRT Patch, Placebo
Comments Statistical analysis for overall treatment comparison.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments P-value for the treatment effect from the Log-Rank test stratified by Cohort.
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Unitless
0.29
(0.05 to 1.70)
0.51
(0.10 to 2.51)
0.50
(0.10 to 2.48)
NA [1] 
(NA to NA)
[1]
Hazard ratio relative to Placebo.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion, NRT Patch, Placebo
Comments Statistical analysis for overall treatment comparison.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments P-value for the treatment effect from the Log-Rank test stratified by Cohort.
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Time to MACE Until the End of Study NCT01574703.
Hide Description 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Unitless
0.39
(0.12 to 1.27)
1.09
(0.42 to 2.83)
0.75
(0.26 to 2.13)
NA [1] 
(NA to NA)
[1]
Hazard ratio relative to Placebo.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion, NRT Patch, Placebo
Comments Statistical analysis for overall treatment comparison.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments P-value for the treatment effect from the Log-Rank test stratified by Cohort.
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
Hide Description 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Unit of Measure: percentage of participants
0.05 0.10 0.05 0.20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion
Comments Statistical analysis between Varenicline and Bupropion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8375
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-5.22 to 4.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, NRT Patch
Comments Statistical analysis between Varenicline and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9780
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-5.20 to 5.05
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis between Varenicline and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6142
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-5.54 to 3.27
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bupropion, NRT Patch
Comments Statistical analysis between Bupropion and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8602
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
-4.28 to 5.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Statistical analysis between Bupropion and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7217
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-4.15 to 2.88
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NRT Patch, Placebo
Comments Statistical analysis between NRT patch and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6322
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-5.41 to 3.28
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
Hide Description 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Unit of Measure: percentage of participants
0.25 0.20 0.10 0.25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion
Comments Statistical analysis between Varenicline and Bupropion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9687
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-3.48 to 3.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, NRT Patch
Comments Statistical analysis between Varenicline and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7905
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-3.58 to 4.70
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis between Varenicline and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8962
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-3.36 to 2.94
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bupropion, NRT Patch
Comments Statistical analysis between Bupropion and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7767
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
-3.72 to 4.98
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Statistical analysis between Bupropion and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9260
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-3.13 to 2.85
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NRT Patch, Placebo
Comments Statistical analysis between NRT patch and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7113
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-4.85 to 3.31
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Unit of Measure: percentage of participants
0.05 0.10 0.10 0.20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion
Comments Statistical analysis between Varenicline and Bupropion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8117
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-5.27 to 4.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, NRT Patch
Comments Statistical analysis between Varenicline and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7303
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-5.21 to 3.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis between Varenicline and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5946
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.20
Confidence Interval (2-Sided) 95%
-5.60 to 3.21
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bupropion, NRT Patch
Comments Statistical analysis between Bupropion and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9200
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-4.27 to 3.85
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Statistical analysis between Bupropion and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7236
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-4.09 to 2.84
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NRT Patch, Placebo
Comments Statistical analysis between NRT patch and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8201
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-4.01 to 3.17
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Unit of Measure: percentage of participants
0.25 0.20 0.15 0.35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion
Comments Statistical analysis between Varenicline and Bupropion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8932
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-3.22 to 2.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, NRT Patch
Comments Statistical analysis between Varenicline and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8747
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-3.09 to 2.63
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis between Varenicline and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6710
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-3.35 to 2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bupropion, NRT Patch
Comments Statistical analysis between Bupropion and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9886
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-3.32 to 3.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Statistical analysis between Bupropion and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7631
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-2.92 to 2.14
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NRT Patch, Placebo
Comments Statistical analysis between NRT patch and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8022
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-3.23 to 2.50
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Incidence of MACE Assessed Until End of Study NCT01574703.
Hide Description 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Unit of Measure: percentage of participants
0.15 0.45 0.30 0.40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion
Comments Statistical analysis between Varenicline and Bupropion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6441
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-4.78 to 2.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, NRT Patch
Comments Statistical analysis between Varenicline and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7327
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-4.63 to 3.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis between Varenicline and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6109
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-4.80 to 2.82
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bupropion, NRT Patch
Comments Statistical analysis between Bupropion and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8707
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-2.48 to 2.93
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Statistical analysis between Bupropion and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9531
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-2.63 to 2.48
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NRT Patch, Placebo
Comments Statistical analysis between NRT patch and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8262
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-2.99 to 2.39
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Incidence of MACE+ Assessed Until End of Study NCT01574703.
Hide Description 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 2016 2006 2022 2014
Measure Type: Number
Unit of Measure: percentage of participants
0.50 0.75 0.49 0.60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Bupropion
Comments Statistical analysis between Varenicline and Bupropion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6105
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-2.84 to 1.67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, NRT Patch
Comments Statistical analysis between Varenicline and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7895
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-2.65 to 2.01
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis between Varenicline and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6804
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-2.75 to 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bupropion, NRT Patch
Comments Statistical analysis between Bupropion and NRT patch.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8127
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-1.95 to 2.49
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bupropion, Placebo
Comments Statistical analysis between Bupropion and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9218
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-2.04 to 2.25
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NRT Patch, Placebo
Comments Statistical analysis between NRT patch and Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8841
Comments P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-2.32 to 2.00
Estimation Comments [Not Specified]
Time Frame Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).
Adverse Event Reporting Description Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.
 
Arm/Group Title Varenicline Bupropion NRT Patch Placebo
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Varenicline Bupropion NRT Patch Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Bupropion NRT Patch Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/1192 (2.85%)   39/1166 (3.34%)   43/1116 (3.85%)   41/1121 (3.66%) 
Cardiac disorders         
Acute myocardial infarction * 1  0/1192 (0.00%)  4/1166 (0.34%)  2/1116 (0.18%)  1/1121 (0.09%) 
Angina pectoris * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  1/1121 (0.09%) 
Angina unstable * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Aortic valve incompetence * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Arrhythmia * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Atrial fibrillation * 1  0/1192 (0.00%)  0/1166 (0.00%)  2/1116 (0.18%)  1/1121 (0.09%) 
Cardiac failure congestive * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  2/1121 (0.18%) 
Coronary artery disease * 1  2/1192 (0.17%)  0/1166 (0.00%)  1/1116 (0.09%)  1/1121 (0.09%) 
Coronary artery occlusion * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Ischaemic cardiomyopathy * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Mitral valve incompetence * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Myocardial infarction * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Stress cardiomyopathy * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Ventricular tachycardia * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Congenital, familial and genetic disorders         
Atrial septal defect * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Ear and labyrinth disorders         
Vertigo * 1  0/1192 (0.00%)  2/1166 (0.17%)  0/1116 (0.00%)  1/1121 (0.09%) 
Endocrine disorders         
Goitre * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Eye disorders         
Chalazion * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Endocrine ophthalmopathy * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Abdominal pain upper * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Colitis * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Diverticulum * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Duodenal stenosis * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Duodenal ulcer perforation * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Enteritis * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Gastritis * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Haematochezia * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Haemorrhoids * 1  0/1192 (0.00%)  1/1166 (0.09%)  1/1116 (0.09%)  0/1121 (0.00%) 
Impaired gastric emptying * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Inguinal hernia strangulated * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Intestinal obstruction * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Pancreatitis * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Small intestinal perforation * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Upper gastrointestinal haemorrhage * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
General disorders         
Chest pain * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  1/1121 (0.09%) 
Death * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Drug withdrawal syndrome * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Hepatobiliary disorders         
Cholangitis * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Cholecystitis acute * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Cholelithiasis * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Gallbladder disorder * 1  0/1192 (0.00%)  0/1166 (0.00%)  2/1116 (0.18%)  0/1121 (0.00%) 
Hepatitis alcoholic * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Immune system disorders         
Drug hypersensitivity * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Infections and infestations         
Appendicitis * 1  0/1192 (0.00%)  1/1166 (0.09%)  1/1116 (0.09%)  2/1121 (0.18%) 
Bronchitis * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Cellulitis * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Diarrhoea infectious * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Diverticulitis * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Erysipelas * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Gastroenteritis viral * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Haemorrhagic fever with renal syndrome * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Meningitis viral * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Necrotising fasciitis * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Perirectal abscess * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Pharyngitis streptococcal * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Pneumonia * 1  1/1192 (0.08%)  0/1166 (0.00%)  3/1116 (0.27%)  0/1121 (0.00%) 
Post procedural infection * 1  1/1192 (0.08%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Pyelonephritis * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Sinusitis * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Staphylococcal infection * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Kidney infection * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Femoral neck fracture * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Joint dislocation * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Ligament rupture * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Ligament sprain * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Multiple injuries * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Periorbital haemorrhage * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Postoperative ileus * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Stab wound * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Sternal fracture * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Ulna fracture * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Investigations         
Hepatic enzyme increased * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Metabolism and nutrition disorders         
Diabetic ketoacidosis * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Hypercalcaemia * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Bursitis * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Intervertebral disc degeneration * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Intervertebral disc protrusion * 1  1/1192 (0.08%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Musculoskeletal pain * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Osteoarthritis * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Rotator cuff syndrome * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Spinal osteoarthritis * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Anogenital warts * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Bladder cancer * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Breast cancer * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Breast neoplasm * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Colon cancer * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Gastric cancer * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Hepatosplenic T-cell lymphoma * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Lung neoplasm malignant * 1  1/1192 (0.08%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Lung adenocarcinoma stage II * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Non-small cell lung cancer * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Ovarian cancer * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Uterine leiomyoma * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Nervous system disorders         
Aphasia * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Carotid artery stenosis * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Cerebral infarction * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Cerebrovascular accident * 1  0/1192 (0.00%)  1/1166 (0.09%)  1/1116 (0.09%)  0/1121 (0.00%) 
Migraine * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Morton’s neuralgia * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Syncope * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Transient ischaemic attack * 1  1/1192 (0.08%)  0/1166 (0.00%)  0/1116 (0.00%)  0/1121 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous * 1  1/1192 (0.08%)  1/1166 (0.09%)  1/1116 (0.09%)  2/1121 (0.18%) 
Premature baby * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Psychiatric disorders         
Adjustment disorder with depressed mood * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Bipolar disorder * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Completed suicide * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Depressed mood * 1  0/1192 (0.00%)  1/1166 (0.09%)  1/1116 (0.09%)  0/1121 (0.00%) 
Major depression * 1  2/1192 (0.17%)  1/1166 (0.09%)  0/1116 (0.00%)  2/1121 (0.18%) 
Psychotic disorder * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Schizophrenia * 1  0/1192 (0.00%)  2/1166 (0.17%)  1/1116 (0.09%)  2/1121 (0.18%) 
Schizophrenia, paranoid type * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Suicidal ideation * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Suicide attempt * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Renal failure * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  1/1121 (0.09%) 
Urinary bladder polyp * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Asthma * 1  1/1192 (0.08%)  1/1166 (0.09%)  2/1116 (0.18%)  0/1121 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/1192 (0.00%)  1/1166 (0.09%)  1/1116 (0.09%)  1/1121 (0.09%) 
Dyspnoea * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Pleurisy * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Pulmonary embolism * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Respiratory failure * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Surgical and medical procedures         
Drug detoxification * 1  0/1192 (0.00%)  0/1166 (0.00%)  0/1116 (0.00%)  1/1121 (0.09%) 
Vascular disorders         
Aortic aneurysm * 1  0/1192 (0.00%)  1/1166 (0.09%)  0/1116 (0.00%)  0/1121 (0.00%) 
Aortic stenosis * 1  0/1192 (0.00%)  1/1166 (0.09%)  1/1116 (0.09%)  0/1121 (0.00%) 
Embolism * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Iliac artery occlusion * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
Peripheral artery stenosis * 1  0/1192 (0.00%)  0/1166 (0.00%)  1/1116 (0.09%)  0/1121 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Bupropion NRT Patch Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   165/1192 (13.84%)   160/1166 (13.72%)   116/1116 (10.39%)   143/1121 (12.76%) 
Infections and infestations         
Nasopharyngitis * 1  103/1192 (8.64%)  78/1166 (6.69%)  69/1116 (6.18%)  81/1121 (7.23%) 
Upper respiratory tract infection * 1  63/1192 (5.29%)  84/1166 (7.20%)  48/1116 (4.30%)  63/1121 (5.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01574703     History of Changes
Other Study ID Numbers: A3051148
2011-005513-37 ( EudraCT Number )
CATS ( Other Identifier: Alias Study Number )
First Submitted: April 6, 2012
First Posted: April 10, 2012
Results First Submitted: July 7, 2016
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016