Trial Outcomes & Findings for Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers (NCT NCT02378714)
NCT ID: NCT02378714
Last Updated: 2021-07-29
Results Overview
Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
27 weeks (24-weeks post-target quit date)
Results posted on
2021-07-29
Participant Flow
Participant milestones
| Measure |
Standard Treatment + Placebo Varenicline
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
81
|
83
|
|
Overall Study
COMPLETED
|
39
|
29
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
29
|
39
|
30
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
Baseline characteristics by cohort
| Measure |
Standard Treatment + Placebo Varenicline
n=68 Participants
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
n=68 Participants
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
n=81 Participants
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
n=83 Participants
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
270 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
50.0 years
STANDARD_DEVIATION 12.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
165 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
135 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
81 participants
n=5 Participants
|
83 participants
n=4 Participants
|
300 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 27 weeks (24-weeks post-target quit date)Population: All participants enrolled in the trial (intent-to-treat sample)
Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27.
Outcome measures
| Measure |
Standard Treatment + Placebo Varenicline
n=68 Participants
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
n=68 Participants
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
n=81 Participants
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
n=83 Participants
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Placebo - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|
|
Bioverified Point-prevalence Abstinence at 27 Weeks
|
6 Participants
|
3 Participants
|
13 Participants
|
13 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)Adverse event and serious adverse event rates between varenicline and placebo arms. A previously developed algorithm was used to classify side effect reports as adverse events (AEs) or serious adverse events (SAEs) (Schnoll et al. 2019). Reference: Schnoll, R., Leone, F., Weisbrot, J., Veluz-Wilkins, A., Miele, A., Hole, A., Jao, N.C., Wileyto, E.P., Carroll, A.J., Kalhan, R., Patel, J., Langer, C., \& Hitsman, B. (2019). A randomized controlled trial of 24-weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. Psycho-Oncology, 28, 561-569.
Outcome measures
| Measure |
Standard Treatment + Placebo Varenicline
n=136 Participants
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
n=164 Participants
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
n=91 Participants
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
n=121 Participants
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Placebo - Week 14
n=74 Participants
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
n=104 Participants
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|
|
Adverse Event and Serious Adverse Event Rates
Any adverse event
|
104 Participants
|
136 Participants
|
68 Participants
|
81 Participants
|
50 Participants
|
60 Participants
|
|
Adverse Event and Serious Adverse Event Rates
Any serious adverse event
|
28 Participants
|
34 Participants
|
26 Participants
|
22 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 14 weeks (11-weeks post-target quit date)Population: All participants enrolled in the trial (intent-to-treat sample)
Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 14 (11-weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 14.
Outcome measures
| Measure |
Standard Treatment + Placebo Varenicline
n=68 Participants
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
n=68 Participants
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
n=81 Participants
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
n=83 Participants
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Placebo - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|
|
Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)
|
8 Participants
|
4 Participants
|
26 Participants
|
26 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 27 weeks (24 weeks post target quit date)\<7 consecutive days of self-reported smoking after a 2-week grace period
Outcome measures
| Measure |
Standard Treatment + Placebo Varenicline
n=57 Participants
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
n=45 Participants
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
n=68 Participants
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
n=70 Participants
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Placebo - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|
|
Prolonged Abstinence
|
13 Participants
|
11 Participants
|
26 Participants
|
26 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 27 weeks (24 weeks post target quit date)No smoking between target quit date (week 3) and week 27
Outcome measures
| Measure |
Standard Treatment + Placebo Varenicline
n=59 Participants
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
n=52 Participants
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
n=72 Participants
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
n=71 Participants
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Placebo - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|
|
Continuous Abstinence
|
3 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 27 weeks (24 weeks post target quit date)Time to relapse as defined by 7 or more consecutive days of self-reported smoking (no grace period)
Outcome measures
| Measure |
Standard Treatment + Placebo Varenicline
n=57 Participants
Standard behavioral smoking cessation treatment plus placebo varenicline
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Placebo Varenicline
n=45 Participants
Behavioral activation for smoking cessation plus placebo varenicline
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Standard Treatment + Active Varenicline
n=68 Participants
Standard behavioral smoking cessation treatment plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
Standard treatment: Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
BASC + Active Varenicline
n=70 Participants
Behavioral activation for smoking cessation plus active varenicline
Varenicline: Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
BASC: The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
|
Placebo - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|
|
Time to 7-day Relapse
|
15 median days to relapse
Interval 15.0 to 16.0
|
15 median days to relapse
Interval 15.0 to 22.0
|
57 median days to relapse
Interval 15.0 to 144.0
|
24 median days to relapse
Interval 15.0 to 135.0
|
—
|
—
|
Adverse Events
Placebo - Week 1
Serious events: 28 serious events
Other events: 104 other events
Deaths: 0 deaths
Varenicline - Week 1
Serious events: 34 serious events
Other events: 136 other events
Deaths: 0 deaths
Placebo - Week 3
Serious events: 24 serious events
Other events: 90 other events
Deaths: 0 deaths
Varenicline - Week 3
Serious events: 29 serious events
Other events: 103 other events
Deaths: 0 deaths
Placebo - Week 4
Serious events: 21 serious events
Other events: 80 other events
Deaths: 0 deaths
Varenicline - Week 4
Serious events: 19 serious events
Other events: 93 other events
Deaths: 0 deaths
Placebo - Week 6
Serious events: 26 serious events
Other events: 68 other events
Deaths: 0 deaths
Varenicline - Week 6
Serious events: 22 serious events
Other events: 81 other events
Deaths: 0 deaths
Placebo - Week 7
Serious events: 18 serious events
Other events: 65 other events
Deaths: 0 deaths
Varenicline - Week 7
Serious events: 18 serious events
Other events: 77 other events
Deaths: 0 deaths
Placebo - Week 8
Serious events: 15 serious events
Other events: 57 other events
Deaths: 0 deaths
Varenicline - Week 8
Serious events: 14 serious events
Other events: 71 other events
Deaths: 0 deaths
Placebo - Week 10
Serious events: 15 serious events
Other events: 51 other events
Deaths: 0 deaths
Varenicline - Week 10
Serious events: 18 serious events
Other events: 71 other events
Deaths: 0 deaths
Placebo - Week 12
Serious events: 12 serious events
Other events: 52 other events
Deaths: 0 deaths
Varenicline - Week 12
Serious events: 12 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo - Week 14
Serious events: 9 serious events
Other events: 50 other events
Deaths: 0 deaths
Varenicline - Week 14
Serious events: 8 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo - Week 27
Serious events: 10 serious events
Other events: 37 other events
Deaths: 0 deaths
Varenicline - Week 27
Serious events: 12 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - Week 1
n=136 participants at risk
Placebo group during first week of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 1
n=164 participants at risk
Varenicline group during first week of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 3
n=114 participants at risk
Placebo group at week 3.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 3
n=137 participants at risk
Varenicline group at week 3.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 4
n=100 participants at risk
Placebo group at week 4.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 4
n=120 participants at risk
Varenicline group at week 4.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 6
n=91 participants at risk
Placebo group mid-treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 6
n=121 participants at risk
Varenicline group mid-treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 7
n=85 participants at risk
Placebo group at week 7.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 7
n=119 participants at risk
Varenicline group at week 7.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 8
n=80 participants at risk
Placebo group at week 8.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 8
n=115 participants at risk
Varenicline group at week 8.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 10
n=79 participants at risk
Placebo group at week 10.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 10
n=113 participants at risk
Varenicline group at week 10.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 12
n=79 participants at risk
Placebo group at week 12.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 12
n=109 participants at risk
Varenicline group at week 12.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 14
n=74 participants at risk
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
n=104 participants at risk
Varenicline group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 27
n=68 participants at risk
Placebo group at week 27.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 27
n=102 participants at risk
Varenicline group at week 27.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Hostility
|
4.4%
6/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.9%
8/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
2/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.0%
8/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.3%
4/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
4/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.1%
5/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.1%
6/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.4%
4/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
7/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.3%
5/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
4/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.4%
4/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Irritability
|
2.9%
4/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.61%
1/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.2%
3/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.0%
4/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
3/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
5/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.3%
4/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
3/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
3/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
2/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.87%
1/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
2/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.92%
1/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.7%
2/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.9%
2/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
2/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.98%
1/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Depressed Mood
|
2.2%
3/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
3/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
4/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.0%
2/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.3%
4/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
6/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.4%
4/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
4/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.7%
4/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.4%
1/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.9%
2/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Suicidal thoughts or i deation
|
2.9%
4/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.1%
15/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.3%
6/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
8/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.0%
3/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
6/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.9%
9/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
6/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
5/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
7/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
5/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.1%
3/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.96%
1/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.9%
5/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Anxiety
|
3.7%
5/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
3/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.88%
1/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.2%
3/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.0%
1/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.3%
4/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.2%
2/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.1%
5/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
3/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
2/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.87%
1/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.7%
3/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.96%
1/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.98%
1/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Agitation
|
14.7%
20/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.6%
19/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
10/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.7%
16/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.0%
12/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.3%
10/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.2%
12/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.4%
9/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.8%
10/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.2%
11/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
7/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.7%
10/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.1%
8/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
10/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.4%
9/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.4%
7/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.8%
5/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.7%
7/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.8%
8/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.9%
4/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Nausea
|
0.00%
0/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.61%
1/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.2%
3/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.2%
2/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.83%
1/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.7%
3/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.98%
1/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
2/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.0%
1/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.84%
1/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.7%
3/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.92%
1/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.96%
1/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Headache
|
0.74%
1/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
3/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.73%
1/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.83%
1/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
3/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.87%
1/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.4%
1/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.9%
2/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.98%
1/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Dizziness
|
0.00%
0/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.83%
1/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.84%
1/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Disturbance in Attention
|
1.5%
2/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
2/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.88%
1/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.2%
3/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.0%
1/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.83%
1/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.87%
1/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.92%
1/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.96%
1/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.98%
1/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Skin swelling or rash
|
0.00%
0/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.0%
1/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
skin redness
|
0.00%
0/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Weakness on one or both sides of the body
|
0.74%
1/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.61%
1/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.73%
1/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.0%
3/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.2%
2/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.87%
1/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.88%
1/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.4%
1/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.98%
1/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Chest Pain
|
0.00%
0/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.73%
1/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.83%
1/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Cardiac disorders
Irregular heartbeat
|
0.74%
1/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Cardiac disorders
Increased heart rate
|
0.74%
1/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
Other adverse events
| Measure |
Placebo - Week 1
n=136 participants at risk
Placebo group during first week of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 1
n=164 participants at risk
Varenicline group during first week of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 3
n=114 participants at risk
Placebo group at week 3.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 3
n=137 participants at risk
Varenicline group at week 3.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 4
n=100 participants at risk
Placebo group at week 4.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 4
n=120 participants at risk
Varenicline group at week 4.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 6
n=91 participants at risk
Placebo group mid-treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 6
n=121 participants at risk
Varenicline group mid-treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 7
n=85 participants at risk
Placebo group at week 7.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 7
n=119 participants at risk
Varenicline group at week 7.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 8
n=80 participants at risk
Placebo group at week 8.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 8
n=115 participants at risk
Varenicline group at week 8.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 10
n=79 participants at risk
Placebo group at week 10.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 10
n=113 participants at risk
Varenicline group at week 10.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 12
n=79 participants at risk
Placebo group at week 12.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 12
n=109 participants at risk
Varenicline group at week 12.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 14
n=74 participants at risk
Placebo group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 14
n=104 participants at risk
Varenicline group at end of treatment.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Placebo - Week 27
n=68 participants at risk
Placebo group at week 27.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
Varenicline - Week 27
n=102 participants at risk
Varenicline group at week 27.
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Nausea
|
2.2%
3/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.3%
7/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.3%
6/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
7/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.0%
6/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.5%
9/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.6%
6/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
6/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.2%
7/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
7/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
5/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.7%
10/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.88%
1/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.8%
3/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.4%
1/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
2/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.9%
5/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.4%
21/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.0%
23/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.4%
13/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
20.4%
28/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.0%
14/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
23.3%
28/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
16.5%
15/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.8%
24/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
16.5%
14/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.6%
21/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.0%
12/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
18.3%
21/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.2%
12/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
18.6%
21/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.0%
15/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.8%
15/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.6%
13/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.6%
11/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.8%
8/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
16.7%
17/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Gastrointestinal disorders
Increased Flatulence
|
7.4%
10/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.7%
6/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
8/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.0%
7/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.3%
10/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.0%
10/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.2%
16/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
5/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.2%
11/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
5/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.6%
11/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.7%
11/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.6%
6/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.1%
6/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.7%
9/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
4/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.9%
4/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Gastrointestinal disorders
Constipation
|
4.4%
6/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.0%
5/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
4/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
5/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.2%
5/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.7%
7/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.3%
10/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
3/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.7%
8/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
5/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.0%
8/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.0%
9/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
4/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.7%
4/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.8%
5/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.8%
5/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
3/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
6/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Sleep problems
|
26.5%
36/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
37.2%
61/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
20.2%
23/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
23.4%
32/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
16.0%
16/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.2%
23/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
22.0%
20/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.7%
13/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
16.5%
14/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.6%
21/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
21.2%
17/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.1%
22/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.1%
8/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.4%
14/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.1%
8/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.9%
13/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
7/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.5%
13/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.8%
8/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.8%
10/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Insomnia
|
15.4%
21/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
22.6%
37/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.5%
12/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.6%
20/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.0%
12/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.3%
10/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.0%
10/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.6%
14/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.1%
12/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.2%
11/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.0%
8/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.4%
12/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.9%
7/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.1%
8/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.7%
10/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
7/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.7%
7/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.8%
8/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.8%
8/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Abnormal Dreams
|
5.9%
8/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.4%
4/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
8/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.0%
6/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.3%
10/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.7%
7/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
7/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.1%
6/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.9%
13/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
5/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.3%
5/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
7/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.4%
9/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.8%
5/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
4/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
3/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Irritability
|
11.8%
16/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
18.3%
30/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.6%
11/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.2%
14/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.0%
12/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.5%
15/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
8/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.2%
16/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.9%
11/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.4%
10/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.0%
12/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.2%
14/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.9%
11/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
10/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.6%
6/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.3%
8/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
7/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
6/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
3/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.9%
7/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Cardiac disorders
Irregular Heartbeat
|
0.74%
1/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.7%
6/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
2/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.0%
3/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
3/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
4/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
3/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.4%
2/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
6/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.8%
3/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.7%
2/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Depressed Mood
|
27.2%
37/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
25.0%
41/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.2%
15/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.3%
21/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.0%
19/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.3%
16/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.9%
9/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.6%
14/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.3%
13/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.3%
17/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.0%
8/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.9%
16/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.0%
15/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.3%
15/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.7%
10/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
6/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
7/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.7%
7/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.2%
9/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.7%
15/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Cardiac disorders
Increased heart rate or palpitations
|
5.1%
7/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.6%
19/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.1%
7/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
8/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
5/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.8%
13/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.7%
7/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.7%
13/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.7%
4/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.9%
13/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
4/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.6%
11/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
4/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
10/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.3%
5/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.2%
10/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.1%
3/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.7%
8/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
2/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Vomiting
|
5.9%
8/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.1%
10/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.6%
9/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.0%
3/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
7/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.3%
3/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
3/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.4%
4/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
2/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.3%
6/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.3%
5/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.8%
3/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.7%
2/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.9%
2/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
2/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.0%
2/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Dry Mouth
|
7.4%
10/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.8%
16/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.9%
9/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
13/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.0%
11/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.2%
17/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
5/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.3%
10/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.1%
6/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.1%
12/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
4/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.1%
7/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
7/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.3%
5/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
7/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.96%
1/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
3/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.0%
2/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Gastrointestinal disorders
Gastroesophageal reflux or indigestion
|
4.4%
6/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.1%
10/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.0%
11/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.0%
9/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
7/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.7%
7/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.4%
9/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.4%
8/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.2%
11/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.1%
7/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
4/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
7/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.8%
5/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
6/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
3/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.9%
7/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Anxiety
|
49.3%
67/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
46.3%
76/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
50.0%
57/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
40.1%
55/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
50.0%
50/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
35.8%
43/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
46.2%
42/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
34.7%
42/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
45.9%
39/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
35.3%
42/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
51.2%
41/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
33.9%
39/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
41.8%
33/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
27.4%
31/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
38.0%
30/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
30.3%
33/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
43.2%
32/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
26.0%
27/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
36.8%
25/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
29.4%
30/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Skin swelling or rash
|
7.4%
10/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.3%
7/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.1%
7/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.73%
1/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.0%
7/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
6/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
5/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
6/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.7%
4/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.2%
5/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.5%
6/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
4/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.7%
3/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.3%
5/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.8%
8/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.8%
5/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
3/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.9%
4/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Agitation
|
24.3%
33/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
26.8%
44/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
25.4%
29/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
21.9%
30/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
31.0%
31/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
28.3%
34/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
25.3%
23/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
24.0%
29/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
23.5%
20/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
23.5%
28/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
26.2%
21/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.4%
20/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
30.4%
24/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.0%
17/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
25.3%
20/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.4%
19/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
28.4%
21/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
16.3%
17/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
20.6%
14/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.6%
20/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Headache
|
4.4%
6/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.1%
15/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.0%
8/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.6%
9/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.0%
7/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
7/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
8/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.4%
9/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.7%
4/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.4%
10/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
4/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.3%
5/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
4/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.4%
1/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.8%
5/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
3/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.9%
5/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Disturbance in attention
|
9.6%
13/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.2%
20/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
10/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
8/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.0%
8/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
7/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.6%
6/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
7/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.4%
8/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.7%
8/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.2%
5/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.4%
12/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.6%
6/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
10/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.6%
5/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
7/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
6/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
6/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
3/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
2/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.0%
1/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.1%
1/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.84%
1/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.2%
1/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.87%
1/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.4%
1/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.96%
1/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Dizziness
|
11.0%
15/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.2%
20/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.9%
9/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.4%
17/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.0%
11/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.5%
9/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.1%
11/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.9%
12/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.8%
10/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.9%
13/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
7/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.6%
11/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.6%
6/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.7%
11/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.6%
6/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
6/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.8%
8/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
4/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
4/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
9/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Fatigue/lethargy
|
26.5%
36/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
25.0%
41/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.5%
20/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.6%
20/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
18.0%
18/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
19.2%
23/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
16.5%
15/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.9%
18/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.6%
15/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.9%
13/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
7/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.8%
17/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.2%
12/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.5%
13/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.9%
7/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.0%
12/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.2%
9/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.6%
11/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
6/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.8%
10/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Feeling of weakness without loss of strength
|
8.8%
12/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.5%
14/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
6/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.0%
7/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.8%
7/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
4/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.6%
8/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
3/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.4%
4/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
2/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.3%
1/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
4/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.00%
0/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
6/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.4%
4/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
3/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
2/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.0%
2/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Skin redness
|
6.6%
9/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.7%
6/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
5/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
4/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.0%
4/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.2%
5/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
5/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.5%
3/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.0%
4/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.6%
6/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.5%
7/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.8%
5/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
4/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.0%
2/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
Psychiatric disorders
Hostility
|
12.5%
17/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.8%
21/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.3%
14/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.0%
11/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.0%
12/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.7%
14/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.5%
5/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.9%
12/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.6%
9/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.1%
18/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.0%
8/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.3%
13/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
17.7%
14/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.7%
11/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.7%
10/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.1%
11/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.2%
9/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.7%
9/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.7%
10/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.8%
8/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Chest pain
|
1.5%
2/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.3%
7/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
6.1%
7/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.9%
4/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.0%
9/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.7%
2/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.4%
4/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.5%
3/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.7%
4/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.9%
7/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
2.6%
3/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.8%
3/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
0.88%
1/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
5.1%
4/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.8%
2/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
4.1%
3/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.9%
2/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
1.5%
1/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
3.9%
4/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
|
General disorders
Weakness on one or both sides of the body
|
15.4%
21/136 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
14.0%
23/164 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
15.8%
18/114 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.2%
14/137 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.0%
9/100 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.3%
10/120 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.7%
7/91 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.4%
9/121 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
10.6%
9/85 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
12.6%
15/119 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.5%
6/80 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.7%
10/115 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.9%
7/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.7%
11/113 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.6%
6/79 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
11.9%
13/109 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
13.5%
10/74 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
9.6%
10/104 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
7.4%
5/68 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
8.8%
9/102 • Medication side effects were measured using a 28-item side effect checklist rating scale at week 1 (1 week before starting medication), week 3 (target quit day) through 14, and week 27.
Adverse events and serious adverse events are reported only for active and placebo medication arms, which aligns with our primary aim for varenicline safety and the statistical analysis plan.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place