Study To Evaluate Cardiac Assessments Following Different... | NCT01574703

ID	Type	Description	Link
2011-005513-37	EudraCT Number
CATS	Other Identifier	Alias Study Number

Study To Evaluate Cardiac Assessments Following Different... | NCT01574703 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
placebo	Experimental	Drug: placebo
varenicline	Experimental	Drug: varenicline tartrate
bupropion	Experimental	Drug: bupropion hydrochloride
Nicotine Replacement Therapy Patch	Experimental	Drug: Nicotine Replacement Therapy Patch

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	All dosing to have taken place per study A3051123	placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).

Secondary Outcomes

Measure	Description	Time Frame
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.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Clinical Research, Inc.		Mobile	Alabama	36608	United States
Pharmacology Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29630702	Derived	Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0012 subjects FG0021 subjects FG0031 subjects
Protocol Violation		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects
Unspecified Reason		FG00027 subjects FG00115 subjects FG00220 subjects FG00316 subjects
Withdrawal by Subject		FG00053 subjects FG00152 subjects FG00236 subjects FG00361 subjects
Met Withdrawal Criteria		FG0000 subjects FG0011 subjects FG0021 subjects FG0030 subjects
Lost to Follow-up		FG00043 subjects FG00141 subjects FG00246 subjects FG00335 subjects
Death		FG0002 subjects FG0011 subjects FG0021 subjects FG0030 subjects

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG0000.29(0.05 to 1.68) OG0010.50(0.10 to 2.50) OG0020.29(0.05 to 1.70) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	Statistical analysis for overall treatment comparison.	Log Rank		0.37	P-value for the treatment effect from the Log-Rank test stratified by Cohort.												No	Superiority or Other

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.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

95% Confidence Interval

Unitless

Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.

ID	Title	Description
OG000	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.
OG001	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.

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.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

95% Confidence Interval

Unitless

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).

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

percentage of participants

Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).

ID	Title	Description
OG000	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.
OG001	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.
OG002	NRT Patch

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.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

percentage of participants

Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).

ID	Title	Description
OG000	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.
OG001	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.
OG002	NRT Patch

Secondary

Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

percentage of participants

Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.

ID	Title	Description
OG000	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.
OG001	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.
OG002

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.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

percentage of participants

Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.

ID	Title	Description
OG000	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.
OG001	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.
OG002	NRT Patch

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.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

percentage of participants

ID	Title	Description
OG000	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.
OG001	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.
OG002	NRT Patch

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.

The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.

Posted

Number

percentage of participants

ID	Title	Description
OG000	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.
OG001	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.
OG002

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	34	1,192	165	1,192
EG001	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.	39	1,166	160	1,166
EG002	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.	43	1,116	116	1,116
EG003	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.	41	1,121	143	1,121

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0014 affected1,166 at risk EG0022 affected1,116 at risk EG0031 affected1,121 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0022 affected1,116 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0012 affected1,166 at risk EG0020 affected1,116 at risk EG003
Goitre	Endocrine disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Chalazion	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Endocrine ophthalmopathy	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Duodenal stenosis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0021 affected1,116 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Chest pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Death	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Gallbladder disorder	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0022 affected1,116 at risk EG003
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Appendicitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0021 affected1,116 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Erysipelas	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Haemorrhagic fever with renal syndrome	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Meningitis viral	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0023 affected1,116 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Kidney infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Periorbital haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Stab wound	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Hepatosplenic T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Lung adenocarcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Aphasia	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0021 affected1,116 at risk EG003
Migraine	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Morton's neuralgia	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0011 affected1,166 at risk EG0021 affected1,116 at risk EG003
Premature baby	Pregnancy, puerperium and perinatal conditions	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0021 affected1,116 at risk EG003
Major depression	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0012 affected1,166 at risk EG0021 affected1,116 at risk EG003
Schizophrenia, paranoid type	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Urinary bladder polyp	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected1,192 at risk EG0011 affected1,166 at risk EG0022 affected1,116 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0021 affected1,116 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Drug detoxification	Surgical and medical procedures	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0020 affected1,116 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0020 affected1,116 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0011 affected1,166 at risk EG0021 affected1,116 at risk EG003
Embolism	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Iliac artery occlusion	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected1,192 at risk EG0010 affected1,166 at risk EG0021 affected1,116 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG000103 affected1,192 at risk EG00178 affected1,166 at risk EG00269 affected1,116 at risk EG00381 affected1,121 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG00063 affected1,192 at risk EG00184 affected1,166 at risk EG00248 affected1,116 at risk EG003

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D011810	Quinoxalines
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	Statistical analysis for overall treatment comparison.	Log Rank		0.53	P-value for the treatment effect from the Log-Rank test stratified by Cohort.												No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	Statistical analysis for overall treatment comparison.	Log Rank		0.34	P-value for the treatment effect from the Log-Rank test stratified by Cohort.												No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Statistical analysis between Varenicline and Bupropion.	Regression, Logistic	0.8375	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.	Risk Difference (RD)	-0.49	2-Sided	95	-5.22	4.23	No	Superiority or Other
OG000 OG002	Statistical analysis between Varenicline and NRT patch.	Regression, Logistic	0.9780	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.	Risk Difference (RD)	-0.07	2-Sided	95	-5.20	5.05	No	Superiority or Other
OG000 OG003	Statistical analysis between Varenicline and Placebo.	Regression, Logistic	0.6142	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.	Risk Difference (RD)	-1.13	2-Sided	95	-5.54	3.27	No	Superiority or Other
OG001 OG002	Statistical analysis between Bupropion and NRT patch.	Regression, Logistic	0.8602	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.	Risk Difference (RD)	0.42	2-Sided	95	-4.28	5.13	No	Superiority or Other
OG001 OG003	Statistical analysis between Bupropion and Placebo.	Regression, Logistic	0.7217	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.	Risk Difference (RD)	-0.64	2-Sided	95	-4.15	2.88	No	Superiority or Other
OG002 OG003	Statistical analysis between NRT patch and Placebo.	Regression, Logistic	0.6322	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.	Risk Difference (RD)	-1.06	2-Sided	95	-5.41	3.28	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Statistical analysis between Varenicline and Bupropion.	Regression, Logistic	0.9687	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.	Risk Difference (RD)	-0.07	2-Sided	95	-3.48	3.34	No	Superiority or Other
OG000 OG002	Statistical analysis between Varenicline and NRT patch.	Regression, Logistic	0.7905	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.	Risk Difference (RD)	0.56	2-Sided	95	-3.58	4.70	No	Superiority or Other
OG000 OG003	Statistical analysis between Varenicline and Placebo.	Regression, Logistic	0.8962	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.	Risk Difference (RD)	-0.21	2-Sided	95	-3.36	2.94	No	Superiority or Other
OG001 OG002	Statistical analysis between Bupropion and NRT patch.	Regression, Logistic	0.7767	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.	Risk Difference (RD)	0.63	2-Sided	95	-3.72	4.98	No	Superiority or Other
OG001 OG003	Statistical analysis between Bupropion and Placebo.	Regression, Logistic	0.9260	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.	Risk Difference (RD)	-0.14	2-Sided	95	-3.13	2.85	No	Superiority or Other
OG002 OG003	Statistical analysis between NRT patch and Placebo.	Regression, Logistic	0.7113	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.	Risk Difference (RD)	-0.77	2-Sided	95	-4.85	3.31	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Statistical analysis between Varenicline and Bupropion.	Regression, Logistic	0.8117	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.	Risk Difference (RD)	-0.57	2-Sided	95	-5.27	4.13	No	Superiority or Other
OG000 OG002	Statistical analysis between Varenicline and NRT patch.	Regression, Logistic	0.7303	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.	Risk Difference (RD)	-0.78	2-Sided	95	-5.21	3.65	No	Superiority or Other
OG000 OG003	Statistical analysis between Varenicline and Placebo.	Regression, Logistic	0.5946	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.	Risk Difference (RD)	-1.20	2-Sided	95	-5.60	3.21	No	Superiority or Other
OG001 OG002	Statistical analysis between Bupropion and NRT patch.	Regression, Logistic	0.9200	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.	Risk Difference (RD)	-0.21	2-Sided	95	-4.27	3.85	No	Superiority or Other
OG001 OG003	Statistical analysis between Bupropion and Placebo.	Regression, Logistic	0.7236	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.	Risk Difference (RD)	-0.62	2-Sided	95	-4.09	2.84	No	Superiority or Other
OG002 OG003	Statistical analysis between NRT patch and Placebo.	Regression, Logistic	0.8201	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.	Risk Difference (RD)	-0.42	2-Sided	95	-4.01	3.17	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Statistical analysis between Varenicline and Bupropion.	Regression, Logistic	0.8932	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.	Risk Difference (RD)	-0.21	2-Sided	95	-3.22	2.81	No	Superiority or Other
OG000 OG002	Statistical analysis between Varenicline and NRT patch.	Regression, Logistic	0.8747	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.	Risk Difference (RD)	-0.23	2-Sided	95	-3.09	2.63	No	Superiority or Other
OG000 OG003	Statistical analysis between Varenicline and Placebo.	Regression, Logistic	0.6710	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.	Risk Difference (RD)	-0.60	2-Sided	95	-3.35	2.15	No	Superiority or Other
OG001 OG002	Statistical analysis between Bupropion and NRT patch.	Regression, Logistic	0.9886	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.	Risk Difference (RD)	-0.02	2-Sided	95	-3.32	3.27	No	Superiority or Other
OG001 OG003	Statistical analysis between Bupropion and Placebo.	Regression, Logistic	0.7631	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.	Risk Difference (RD)	-0.39	2-Sided	95	-2.92	2.14	No	Superiority or Other
OG002 OG003	Statistical analysis between NRT patch and Placebo.	Regression, Logistic	0.8022	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.	Risk Difference (RD)	-0.37	2-Sided	95	-3.23	2.50	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Statistical analysis between Varenicline and Bupropion.	Regression, Logistic	0.6441	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.	Risk Difference (RD)	-0.91	2-Sided	95	-4.78	2.96	No	Superiority or Other
OG000 OG002	Statistical analysis between Varenicline and NRT patch.	Regression, Logistic	0.7327	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.	Risk Difference (RD)	-0.69	2-Sided	95	-4.63	3.26	No	Superiority or Other
OG000 OG003	Statistical analysis between Varenicline and Placebo.	Regression, Logistic	0.6109	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.	Risk Difference (RD)	-0.99	2-Sided	95	-4.80	2.82	No	Superiority or Other
OG001 OG002	Statistical analysis between Bupropion and NRT patch.	Regression, Logistic	0.8707	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.	Risk Difference (RD)	0.22	2-Sided	95	-2.48	2.93	No	Superiority or Other
OG001 OG003	Statistical analysis between Bupropion and Placebo.	Regression, Logistic	0.9531	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.	Risk Difference (RD)	-0.08	2-Sided	95	-2.63	2.48	No	Superiority or Other
OG002 OG003	Statistical analysis between NRT patch and Placebo.	Regression, Logistic	0.8262	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.	Risk Difference (RD)	-0.30	2-Sided	95	-2.99	2.39	No	Superiority or Other

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Statistical analysis between Varenicline and Bupropion.	Regression, Logistic	0.6105	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.	Risk Difference (RD)	-0.59	2-Sided	95	-2.84	1.67	No	Superiority or Other
OG000 OG002	Statistical analysis between Varenicline and NRT patch.	Regression, Logistic	0.7895	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.	Risk Difference (RD)	-0.32	2-Sided	95	-2.65	2.01	No	Superiority or Other
OG000 OG003	Statistical analysis between Varenicline and Placebo.	Regression, Logistic	0.6804	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.	Risk Difference (RD)	-0.48	2-Sided	95	-2.75	1.80	No	Superiority or Other
OG001 OG002	Statistical analysis between Bupropion and NRT patch.	Regression, Logistic	0.8127	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.	Risk Difference (RD)	0.27	2-Sided	95	-1.95	2.49	No	Superiority or Other
OG001 OG003	Statistical analysis between Bupropion and Placebo.	Regression, Logistic	0.9218	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.	Risk Difference (RD)	0.11	2-Sided	95	-2.04	2.25	No	Superiority or Other
OG002 OG003	Statistical analysis between NRT patch and Placebo.	Regression, Logistic	0.8841	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.	Risk Difference (RD)	-0.16	2-Sided	95	-2.32	2.00	No	Superiority or Other

ID	Term
D016540	Smoking Cessation
D001523	Mental Disorders

ID	Term
D015438	Health Behavior
D001519	Behavior