| Primary | Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | 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. | Posted | | Number | | participants | | Baseline through Week 12 or Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| Non-serious AEs | | | | SAEs | | |
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| Secondary | Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks | 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?) | | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks | 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?) | All-subjects population in Belgium | Posted | | Number | | participants | | Week 12 and Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Treatment Responders at Week 12 | 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? | | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Treatment Responders in Belgium at Week 12 and at Week 24 | 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? | All-subjects population in Belgium | Posted | | Number | | participants | | Week 12 and Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11 | 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. | | Posted | | Number | | participants | | Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11 | 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. | 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) . | Posted | | Number | | participants | | Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12 | 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 | | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants Who Received Varenicline, by Duration of Treatment in Days | | All-subjects population; Week 24 if a maintenance period was prescribed. | Posted | | Number | | participants | | Baseline through Week 12 or Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program | Number of participants who answered 'yes' to the question "Did you register with LifeREWARDS?" (LifeREWARDS not available in Greece.) | All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit). | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium | 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) | All subjects population in Belgium; n=number of participants with analyzable data at observation. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 7 and Week 13 or 14 (Week 13/14) | | | | ID | Title | Description |
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| OG000 | 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. |
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