Trial Outcomes & Findings for Varenicline Observational Investigation In The Cessation of Smoking (NCT NCT00669240)
NCT ID: NCT00669240
Last Updated: 2015-07-23
Results Overview
Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.
Recruitment status
COMPLETED
Target enrollment
567 participants
Primary outcome timeframe
Baseline through Week 12 or Week 24
Results posted on
2015-07-23
Participant Flow
Participant milestones
| Measure |
Varenicline
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Overall Study
STARTED
|
567
|
|
Overall Study
Assigned to Treatment
|
566
|
|
Overall Study
Received Treatment
|
551
|
|
Overall Study
COMPLETED
|
402
|
|
Overall Study
NOT COMPLETED
|
165
|
Reasons for withdrawal
| Measure |
Varenicline
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
33
|
|
Overall Study
Withdrawal by Subject
|
42
|
|
Overall Study
Lost to Follow-up
|
34
|
|
Overall Study
Adverse Event
|
21
|
|
Overall Study
Other
|
19
|
|
Overall Study
Enrolled but not treated
|
15
|
|
Overall Study
Enrolled but no dosing record
|
1
|
Baseline Characteristics
Varenicline Observational Investigation In The Cessation of Smoking
Baseline characteristics by cohort
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Age, Customized
<55 years
|
415 participants
n=5 Participants
|
|
Age, Customized
>=55 years and <=65 years
|
107 participants
n=5 Participants
|
|
Age, Customized
>65 years
|
26 participants
n=5 Participants
|
|
Age, Customized
Unspecified
|
3 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
295 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
248 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unspecified
|
8 participants
n=5 Participants
|
|
Number of years participants smoked
|
27.0 years
n=5 Participants
|
|
Average number of cigarettes participants smoked per day
|
25.3 cigarettes per day
n=5 Participants
|
|
Number of participants with quit smoking history
|
426 participants
n=5 Participants
|
|
Total score on the Fagerstrom Test for Nicotine Dependence
|
6.1 scores on a scale
n=5 Participants
|
|
Reasons for quitting smoking
Family / friends
|
255 participants
n=5 Participants
|
|
Reasons for quitting smoking
Health reasons
|
495 participants
n=5 Participants
|
|
Reasons for quitting smoking
Money / cost
|
159 participants
n=5 Participants
|
|
Reasons for quitting smoking
Body image / appearance
|
84 participants
n=5 Participants
|
|
Reasons for quitting smoking
Smoking ban in public places
|
35 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Diabetes
|
31 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Raised cholesterol
|
114 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Hypertension
|
110 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Cardiovascular disease
|
54 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Chronic obstructive pulmonary disease (COPD)
|
100 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Lung cancer
|
10 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Epilepsy
|
9 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Psychiatric disorders (excluding depression)
|
18 participants
n=5 Participants
|
|
Smoking-related concurrent illnesses and cardiovascular risk factors
Depression
|
52 participants
n=5 Participants
|
|
Source of reimbursement
Public insurance
|
214 participants
n=5 Participants
|
|
Source of reimbursement
Private insurance
|
2 participants
n=5 Participants
|
|
Source of reimbursement
Self-payment
|
353 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12 or Week 24Population: Safety population, which is identical to the all-subjects population: all enrolled subjects who received at least 1 dose (including partial doses) of varenicline; Week 24 if a maintenance period was prescribed.
Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Non-serious AEs
|
131 participants
|
|
Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
7 participants
|
SECONDARY outcome
Timeframe: Week 12Population: All-subjects population
Number of participants who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered "no" to both of the following 2 questions, and non-responders are participants who answered "yes" to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
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|---|---|
|
Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks
Responders
|
356 participants
|
|
Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks
Non-responders
|
135 participants
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: All-subjects population in Belgium
Number of participants in Belgium who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered "no" to both of the following 2 questions, and non-responders are participants who answered "yes" to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)
Outcome measures
| Measure |
Varenicline
n=226 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
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|---|---|
|
Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
Week 12 Responders
|
138 participants
|
|
Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
Week 12 Non-responders
|
41 participants
|
|
Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
Week 24 Responders
|
103 participants
|
|
Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
Week 24 Non-responders
|
34 participants
|
SECONDARY outcome
Timeframe: Week 12Population: All-subjects population
Responders are participants who answered "no" to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
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|---|---|
|
Number of Treatment Responders at Week 12
|
356 participants
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: All-subjects population in Belgium
Responders are participants who answered "no" to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?
Outcome measures
| Measure |
Varenicline
n=226 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
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|---|---|
|
Number of Treatment Responders in Belgium at Week 12 and at Week 24
Week 12
|
138 participants
|
|
Number of Treatment Responders in Belgium at Week 12 and at Week 24
Week 24
|
103 participants
|
SECONDARY outcome
Timeframe: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11Population: All-subjects population
Assessment of smoking cessation (ie, not a single puff) in previous 7 days, at time points of routine review of patients per local clinical practice.
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
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|---|---|
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Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 3
|
105 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 4
|
129 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 5
|
84 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 6
|
65 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 7
|
50 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 8
|
45 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 9
|
38 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 10
|
18 participants
|
|
Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
Week 11
|
23 participants
|
SECONDARY outcome
Timeframe: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11Population: All-subjects population; n=number of participants in the All-subjects population with analyzable data (responders and non-responders) who were assessed for smoking cessation at the time point (per local clinical practice) .
Responders are participants who answered "no" to the following 2 questions: 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days? Assessment conducted at specified time points only when usual for the local clinical practice.
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
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|---|---|
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Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 3 (n=105)
|
65 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 4 (n=129)
|
89 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 5 (n=84)
|
62 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 6 (n=65)
|
50 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 7 (n=50)
|
43 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 8 (n=45)
|
35 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 9 (n=38)
|
28 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 10 (n=18)
|
11 participants
|
|
Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
Week 11 (n=23)
|
19 participants
|
SECONDARY outcome
Timeframe: Week 12Population: All-subjects population
A maintenance period was an additional period of varenicline treatment that could be prescribed at Week 12 by the attending primary care physician in routine clinical practice
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12
|
60 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 12 or Week 24Population: All-subjects population; Week 24 if a maintenance period was prescribed.
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
<=1 day
|
3 participants
|
|
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
2-7 days
|
8 participants
|
|
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
8-14 days
|
19 participants
|
|
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
15-28 days
|
48 participants
|
|
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
29-60 days
|
85 participants
|
|
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
61-90 days
|
280 participants
|
|
Number of Participants Who Received Varenicline, by Duration of Treatment in Days
>=91 days
|
108 participants
|
SECONDARY outcome
Timeframe: Week 12Population: All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit).
Number of participants who answered 'yes' to the question "Did you register with LifeREWARDS?" (LifeREWARDS not available in Greece.)
Outcome measures
| Measure |
Varenicline
n=551 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
Belgium (n=194)
|
65 participants
|
|
Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
Greece (n=98)
|
0 participants
|
|
Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
Hungary (n=107)
|
3 participants
|
|
Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
Slovenia (n=15)
|
2 participants
|
SECONDARY outcome
Timeframe: Week 7 and Week 13 or 14 (Week 13/14)Population: All subjects population in Belgium; n=number of participants with analyzable data at observation.
Self-administered rating of intensity of nicotine withdrawal symptoms over past 24 hours; consists of 9 questions (urge to smoke, depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty going to sleep, difficulty staying asleep), each rated 0-4 (0=not at all, 1=slight, 2=moderate, 3=quite a bit, 4=extreme). Subscales: Negative affect domain (average of items 2-5); Insomnia domain (average of items 8 and 9); Urge to smoke (item 1); Restlessness (item 6); Increased appetite (item 7). Range 0-4 (higher score=greater intensity of symptoms)
Outcome measures
| Measure |
Varenicline
n=226 Participants
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 7: Negative affect domain (n=137)
|
0.7 scores on a scale
Standard Deviation 0.7
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 13/14: Negative affect domain (n=137)
|
0.6 scores on a scale
Standard Deviation 0.7
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 7: Insomnia domain (n=137)
|
0.8 scores on a scale
Standard Deviation 1.0
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 13/14: Insomnia domain (n=137)
|
0.5 scores on a scale
Standard Deviation 0.8
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 7: Urge to smoke (n=137)
|
1.1 scores on a scale
Standard Deviation 1.0
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 13/14: Urge to smoke (n=137)
|
0.8 scores on a scale
Standard Deviation 0.9
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 7: Restlessness (n=137)
|
0.8 scores on a scale
Standard Deviation 1.0
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 13/14: Restlessness (n=137)
|
0.6 scores on a scale
Standard Deviation 0.9
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 7: Increased appetite (n=134)
|
1.1 scores on a scale
Standard Deviation 1.2
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
Week 13/14: Increased appetite (n=134)
|
0.9 scores on a scale
Standard Deviation 1.1
|
Adverse Events
Varenicline
Serious events: 7 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=551 participants at risk
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Cardiac disorders
Cardiovascular disorder
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental disorder
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Varenicline
n=551 participants at risk
According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
9/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
6/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
8.9%
49/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
1.3%
7/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Abnormal dreams
|
1.8%
10/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
2.9%
16/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
2.2%
12/551 • 12 weeks and up to 24 weeks for participants presribed maintenance period
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER