Trial Outcomes & Findings for Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype (NCT NCT00894166)
NCT ID: NCT00894166
Last Updated: 2013-09-23
Results Overview
A self report of no cigarettes smoked confirmed by expired air carbon monoxide of \<=10ppm was the criterion for abstinence.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
606 participants
Primary outcome timeframe
weeks 8-11 after quit date
Results posted on
2013-09-23
Participant Flow
Study started June 2009 and ended April 2011 and was conducted at Duke University Medical Center.
All enrollees began nicotine patches \& those who didn't show a \>50% reduction in expired air carbon monoxide (CO) at 1 week (1 week before the target quit date) or who lapsed in the 1st week after their quit date were randomized to one of 6 groups. The 7th group - Nicotine Replacement Therapy (NRT) Responders were excluded from this randomization.
Participant milestones
| Measure |
NRT Responder
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
|
Pre-Quit Randomization to Bupropion + NRT
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
|
Pre-Quit Randomization to Varenicline
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks).
|
Pre-Quit Randomization to NRT
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
|
Post-Quit Randomization to Bupropion + NRT
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
|
Post-Quit Randomized to Varenicline
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks).
|
Post-Quit Randomized to NRT
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
|
Withdrew Prior to Randomization
These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
132
|
109
|
112
|
114
|
34
|
36
|
35
|
34
|
|
Overall Study
COMPLETED
|
71
|
46
|
50
|
45
|
10
|
20
|
19
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
63
|
62
|
69
|
24
|
16
|
16
|
34
|
Reasons for withdrawal
| Measure |
NRT Responder
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
|
Pre-Quit Randomization to Bupropion + NRT
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
|
Pre-Quit Randomization to Varenicline
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks).
|
Pre-Quit Randomization to NRT
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
|
Post-Quit Randomization to Bupropion + NRT
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
|
Post-Quit Randomized to Varenicline
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks).
|
Post-Quit Randomized to NRT
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
|
Withdrew Prior to Randomization
These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrew or Lost to Follow-Up
|
61
|
63
|
62
|
68
|
24
|
16
|
16
|
34
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
Baseline characteristics by cohort
| Measure |
NRT Responder
n=132 Participants
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
|
Pre-Quit Randomization to Bupropion + NRT
n=109 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
|
Pre-Quit Randomization to Varenicline
n=112 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
|
Pre-Quit Randomization to NRT
n=114 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
|
Post-Quit Randomization to Bupropion + NRT
n=34 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
|
Post-Quit Randomized to Varenicline
n=36 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
|
Post-Quit Randomized to NRT
n=35 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
|
Withdrew Prior to Randomization
n=34 Participants
These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
|
Total
n=606 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
34 Participants
n=24 Participants
|
601 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Age Continuous
|
43.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
43.1 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
44.1 years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
40.8 years
STANDARD_DEVIATION 12.8 • n=8 Participants
|
40.7 years
STANDARD_DEVIATION 10.1 • n=24 Participants
|
44.3 years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
300 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
306 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
132 participants
n=5 Participants
|
109 participants
n=7 Participants
|
112 participants
n=5 Participants
|
114 participants
n=4 Participants
|
34 participants
n=21 Participants
|
36 participants
n=8 Participants
|
35 participants
n=8 Participants
|
34 participants
n=24 Participants
|
606 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: weeks 8-11 after quit datePopulation: All participants were included in the analyses except those dropping out prior to randomization points, those censored for taking contraindicated medications or failing to meet other inclusion criteria, and one death having no apparent relationship to treatment.
A self report of no cigarettes smoked confirmed by expired air carbon monoxide of \<=10ppm was the criterion for abstinence.
Outcome measures
| Measure |
NRT Responder
n=120 Participants
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
|
Pre-Quit Randomization to Bupropion + NRT
n=99 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
|
Pre-Quit Randomization to Varenicline
n=103 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
|
Pre-Quit Randomization to NRT
n=106 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
|
Post-Quit Randomization to Bupropion + NRT
n=30 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
|
Post-Quit Randomized to Varenicline
n=35 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
|
Post-Quit Randomized to NRT
n=30 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
|
|---|---|---|---|---|---|---|---|
|
Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)
|
59.2 percentage of subjects abstinent
Interval 50.4 to 68.0
|
28.3 percentage of subjects abstinent
Interval 19.4 to 37.2
|
23.3 percentage of subjects abstinent
Interval 15.1 to 31.5
|
16.0 percentage of subjects abstinent
Interval 9.0 to 23.0
|
26.7 percentage of subjects abstinent
Interval 10.9 to 42.5
|
37.1 percentage of subjects abstinent
Interval 21.1 to 53.1
|
26.7 percentage of subjects abstinent
Interval 10.9 to 42.5
|
SECONDARY outcome
Timeframe: point abstinence (7 days) at 6 months post-quit dateOutcome measures
| Measure |
NRT Responder
n=120 Participants
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
|
Pre-Quit Randomization to Bupropion + NRT
n=99 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
|
Pre-Quit Randomization to Varenicline
n=108 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
|
Pre-Quit Randomization to NRT
n=106 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
|
Post-Quit Randomization to Bupropion + NRT
n=30 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
|
Post-Quit Randomized to Varenicline
n=35 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
|
Post-Quit Randomized to NRT
n=30 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
|
|---|---|---|---|---|---|---|---|
|
Abstinence (7 Days) at 6 Months.
|
21.7 percentage of subjects
|
17.2 percentage of subjects
|
16.5 percentage of subjects
|
6.6 percentage of subjects
|
10.0 percentage of subjects
|
20.0 percentage of subjects
|
13.3 percentage of subjects
|
SECONDARY outcome
Timeframe: continuous abstinence at 6 months post quit dayOutcome measures
| Measure |
NRT Responder
n=120 Participants
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
|
Pre-Quit Randomization to Bupropion + NRT
n=99 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
|
Pre-Quit Randomization to Varenicline
n=108 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
|
Pre-Quit Randomization to NRT
n=106 Participants
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
|
Post-Quit Randomization to Bupropion + NRT
n=30 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
|
Post-Quit Randomized to Varenicline
n=35 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
|
Post-Quit Randomized to NRT
n=30 Participants
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
|
|---|---|---|---|---|---|---|---|
|
Continuous Abstinence From Smoking at 6 Months Post Quit.
|
20.0 percentage of subjects
|
13.1 percentage of subjects
|
5.8 percentage of subjects
|
5.8 percentage of subjects
|
10.0 percentage of subjects
|
14.3 percentage of subjects
|
10.0 percentage of subjects
|
Adverse Events
NRT Responder
Serious events: 3 serious events
Other events: 88 other events
Deaths: 0 deaths
Pre-Quit Randomization to Bupropion + NRT
Serious events: 4 serious events
Other events: 74 other events
Deaths: 0 deaths
Pre-Quit Randomization to Varenicline
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Pre-Quit Randomization to NRT
Serious events: 2 serious events
Other events: 85 other events
Deaths: 0 deaths
Post-Quit Randomization to Bupropion + NRT
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Post-Quit Randomized to Varenicline
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Post-Quit Randomized to NRT
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NRT Responder
n=132 participants at risk
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
|
Pre-Quit Randomization to Bupropion + NRT
n=109 participants at risk
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
|
Pre-Quit Randomization to Varenicline
n=112 participants at risk
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
|
Pre-Quit Randomization to NRT
n=114 participants at risk
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
|
Post-Quit Randomization to Bupropion + NRT
n=34 participants at risk
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
|
Post-Quit Randomized to Varenicline
n=36 participants at risk
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
|
Post-Quit Randomized to NRT
n=35 participants at risk
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Chest Pain, shortness of breath, vision loss
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.92%
1/109 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Injury, poisoning and procedural complications
Hives, itching, knot in throat
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.92%
1/109 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Cardiac disorders
Chest Pain, myocardial infarction
|
0.76%
1/132 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain worsened with inspiration
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/34 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Psychiatric disorders
psychiatric side effects
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.89%
1/112 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Immune system disorders
urticaria and shortness of breath
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.92%
1/109 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Cardiac disorders
paroxsymal supraventricular tachycardia and fainting
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.92%
1/109 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Cardiac disorders
chest pain, new left bundle branch block
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/34 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer
|
0.76%
1/132 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Cardiac disorders
Chest pain, unifocal PVCs
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.89%
1/112 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Immune system disorders
Rash distant from patch site
|
0.76%
1/132 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
Hallucinations, chest pains, vomiting
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.88%
1/114 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
Body aches, generalized weakness, sensation of throat swelling, lightheadedness,difficulty breathing
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.89%
1/112 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Vascular disorders
stroke and death
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.88%
1/114 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Cardiac disorders
myocardial infaction
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/109 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.8%
1/36 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/35 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
Other adverse events
| Measure |
NRT Responder
n=132 participants at risk
Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
|
Pre-Quit Randomization to Bupropion + NRT
n=109 participants at risk
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
|
Pre-Quit Randomization to Varenicline
n=112 participants at risk
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
|
Pre-Quit Randomization to NRT
n=114 participants at risk
Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
|
Post-Quit Randomization to Bupropion + NRT
n=34 participants at risk
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
|
Post-Quit Randomized to Varenicline
n=36 participants at risk
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
|
Post-Quit Randomized to NRT
n=35 participants at risk
Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
13.6%
18/132 • Number of events 23 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
15.6%
17/109 • Number of events 21 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.0%
9/112 • Number of events 9 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
14.9%
17/114 • Number of events 22 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
14.7%
5/34 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
16.7%
6/36 • Number of events 7 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.4%
4/35 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
EXCESSIVE SWEATING
|
5.3%
7/132 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.0%
12/109 • Number of events 21 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.6%
4/112 • Number of events 5 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
10.5%
12/114 • Number of events 18 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.8%
4/34 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.3%
3/36 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
17.1%
6/35 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
SWELLING
|
2.3%
3/132 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.92%
1/109 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.7%
3/112 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
1.8%
2/114 • Number of events 2 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.9%
2/34 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
MOUTH/THROAT IRRITATION
|
8.3%
11/132 • Number of events 15 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
6.4%
7/109 • Number of events 9 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
1.8%
2/112 • Number of events 2 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.5%
4/114 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.9%
2/34 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.8%
1/36 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.4%
4/35 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
DRY MOUTH
|
10.6%
14/132 • Number of events 24 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
17.4%
19/109 • Number of events 43 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
6.2%
7/112 • Number of events 14 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
15.8%
18/114 • Number of events 28 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
23.5%
8/34 • Number of events 22 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.1%
4/36 • Number of events 7 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
22.9%
8/35 • Number of events 25 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
THIRST
|
14.4%
19/132 • Number of events 33 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
19.3%
21/109 • Number of events 41 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
10.7%
12/112 • Number of events 25 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
20.2%
23/114 • Number of events 36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
29.4%
10/34 • Number of events 24 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
22.2%
8/36 • Number of events 12 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
22.9%
8/35 • Number of events 25 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
COUGHING
|
7.6%
10/132 • Number of events 16 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
10.1%
11/109 • Number of events 21 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
13.4%
15/112 • Number of events 29 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.4%
13/114 • Number of events 17 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.8%
4/34 • Number of events 9 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
13.9%
5/36 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
17.1%
6/35 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
CHEST PAIN
|
0.00%
0/132 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.92%
1/109 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/112 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.88%
1/114 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.8%
3/34 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.6%
2/36 • Number of events 2 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
JOINT / MUSCLE PAIN
|
10.6%
14/132 • Number of events 22 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.7%
4/109 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.6%
4/112 • Number of events 7 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
7.9%
9/114 • Number of events 10 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
20.6%
7/34 • Number of events 19 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.3%
3/36 • Number of events 5 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.4%
4/35 • Number of events 10 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Gastrointestinal disorders
HEARTBURN
|
6.8%
9/132 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
6.4%
7/109 • Number of events 18 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.6%
4/112 • Number of events 7 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.5%
4/114 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.8%
4/34 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.3%
3/36 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.7%
2/35 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Gastrointestinal disorders
NAUSEA
|
6.8%
9/132 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.7%
4/109 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.6%
4/112 • Number of events 5 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.5%
4/114 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.8%
4/34 • Number of events 5 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.3%
3/36 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.6%
3/35 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.3%
7/132 • Number of events 13 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.3%
9/109 • Number of events 16 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.7%
3/112 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.3%
6/114 • Number of events 9 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/34 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.6%
2/36 • Number of events 2 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.4%
4/35 • Number of events 13 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Gastrointestinal disorders
UPSET STOMACH
|
6.1%
8/132 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.8%
3/109 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.7%
3/112 • Number of events 5 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.3%
6/114 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.9%
2/34 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.8%
1/36 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.7%
2/35 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Gastrointestinal disorders
DIARRHEA
|
0.76%
1/132 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
1.8%
2/109 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.4%
6/112 • Number of events 7 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.6%
3/114 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/35 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Nervous system disorders
IRRITABILITY
|
15.2%
20/132 • Number of events 35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
14.7%
16/109 • Number of events 22 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
16.1%
18/112 • Number of events 31 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
13.2%
15/114 • Number of events 31 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
26.5%
9/34 • Number of events 15 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
33.3%
12/36 • Number of events 22 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
20.0%
7/35 • Number of events 10 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Nervous system disorders
NIGHTMARES
|
6.1%
8/132 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
4.6%
5/109 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
7.1%
8/112 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
7.9%
9/114 • Number of events 9 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.8%
1/36 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
20.0%
7/35 • Number of events 10 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Nervous system disorders
VIVID DREAMS
|
27.3%
36/132 • Number of events 85 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
32.1%
35/109 • Number of events 74 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
22.3%
25/112 • Number of events 50 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
34.2%
39/114 • Number of events 87 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
35.3%
12/34 • Number of events 38 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
38.9%
14/36 • Number of events 28 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
48.6%
17/35 • Number of events 51 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Nervous system disorders
INSOMNIA
|
15.2%
20/132 • Number of events 33 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
23.9%
26/109 • Number of events 37 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
12.5%
14/112 • Number of events 17 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
17.5%
20/114 • Number of events 34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
32.4%
11/34 • Number of events 29 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
16.7%
6/36 • Number of events 16 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
25.7%
9/35 • Number of events 14 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Psychiatric disorders
DEPRESSION
|
2.3%
3/132 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.8%
3/109 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.4%
6/112 • Number of events 8 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
7.0%
8/114 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/34 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.6%
2/36 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.6%
3/35 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Psychiatric disorders
ANXIETY
|
10.6%
14/132 • Number of events 15 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
14.7%
16/109 • Number of events 26 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
7.1%
8/112 • Number of events 15 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
7.9%
9/114 • Number of events 23 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
17.6%
6/34 • Number of events 10 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.6%
2/36 • Number of events 5 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
20.0%
7/35 • Number of events 9 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Nervous system disorders
TREMOR
|
0.76%
1/132 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
4.6%
5/109 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.89%
1/112 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/114 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.9%
2/34 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/35 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Nervous system disorders
DECREASED LIBIDO
|
3.8%
5/132 • Number of events 5 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.7%
4/109 • Number of events 10 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.4%
6/112 • Number of events 12 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
1.8%
2/114 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/34 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/35 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
ITCHING/BURNING AT PATCH SITE
|
20.5%
27/132 • Number of events 63 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
17.4%
19/109 • Number of events 28 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
11.6%
13/112 • Number of events 14 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
26.3%
30/114 • Number of events 44 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
29.4%
10/34 • Number of events 26 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
19.4%
7/36 • Number of events 11 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
31.4%
11/35 • Number of events 26 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
RASH AT PATCH SITE
|
12.9%
17/132 • Number of events 30 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
7.3%
8/109 • Number of events 9 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.4%
6/112 • Number of events 7 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.8%
10/114 • Number of events 15 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.9%
2/34 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
8.3%
3/36 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
17.1%
6/35 • Number of events 12 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
|
General disorders
RASH DISTANT FROM PATCH SITE
|
3.0%
4/132 • Number of events 6 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.8%
3/109 • Number of events 3 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
1.8%
2/112 • Number of events 2 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
3.5%
4/114 • Number of events 4 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
2.9%
1/34 • Number of events 1 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
0.00%
0/36 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
5.7%
2/35 • Number of events 2 • Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place