Trial Outcomes & Findings for Combining Varenicline and Bupropion for Smoking Cessation (NCT NCT00943618)
NCT ID: NCT00943618
Last Updated: 2025-05-04
Results Overview
Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
641 participants
Primary outcome timeframe
From quit date to 12 months.
Results posted on
2025-05-04
Participant Flow
Paid and unpaid media advertising from May 2010 to July 2013 recruited volunteer smokers from the Houston, Texas metropolitan area. Inclusion criteria included: 25- 65 years of age; smoke five or more cigarettes per day (CPD); baseline expired carbon monoxide (CO) level greater than 6 parts per million (p.m.); fluent in English; stable residency.
641 patients were consented to this study; 250 patients were screen failures.
Participant milestones
| Measure |
Varenicline + Bupropion
Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
|
Varenicline
Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
|
Placebo
Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
163
|
166
|
56
|
|
Overall Study
COMPLETED
|
108
|
89
|
25
|
|
Overall Study
NOT COMPLETED
|
55
|
77
|
31
|
Reasons for withdrawal
| Measure |
Varenicline + Bupropion
Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
|
Varenicline
Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
|
Placebo
Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
38
|
48
|
20
|
|
Overall Study
Discontinued Medication
|
17
|
29
|
11
|
Baseline Characteristics
Combining Varenicline and Bupropion for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Varenicline + Bupropion
n=163 Participants
Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
|
Varenicline
n=166 Participants
Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
|
Placebo
n=56 Participants
Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.36 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
48.75 years
STANDARD_DEVIATION 10.89 • n=7 Participants
|
48.48 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
48.97 years
STANDARD_DEVIATION 10.17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
340 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
163 participants
n=5 Participants
|
166 participants
n=7 Participants
|
56 participants
n=5 Participants
|
385 participants
n=4 Participants
|
|
Marital Status
Married or Living with partner
|
42.94 percentage of participants
n=5 Participants
|
53.01 percentage of participants
n=7 Participants
|
62.50 percentage of participants
n=5 Participants
|
50.13 percentage of participants
n=4 Participants
|
|
Marital Status
Other
|
57.06 percentage of participants
n=5 Participants
|
46.99 percentage of participants
n=7 Participants
|
37.50 percentage of participants
n=5 Participants
|
49.87 percentage of participants
n=4 Participants
|
|
Employment Status
Employed/Student
|
82.72 percentage of participants
n=5 Participants
|
80.72 percentage of participants
n=7 Participants
|
78.57 percentage of participants
n=5 Participants
|
81.25 percentage of participants
n=4 Participants
|
|
Employment Status
Unemployed
|
17.28 percentage of participants
n=5 Participants
|
19.28 percentage of participants
n=7 Participants
|
21.43 percentage of participants
n=5 Participants
|
18.75 percentage of participants
n=4 Participants
|
|
Depression History
Positive
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Depression History
Negative
|
154 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
362 Participants
n=4 Participants
|
|
Years of education
|
13.89 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
13.60 years
STANDARD_DEVIATION 1.92 • n=7 Participants
|
13.80 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
13.75 years
STANDARD_DEVIATION 2 • n=4 Participants
|
|
Current Smoking Rate
|
19.64 cigs per day
STANDARD_DEVIATION 9.49 • n=5 Participants
|
19.02 cigs per day
STANDARD_DEVIATION 9.49 • n=7 Participants
|
19.71 cigs per day
STANDARD_DEVIATION 11.20 • n=5 Participants
|
19.66 cigs per day
STANDARD_DEVIATION 9.45 • n=4 Participants
|
|
Number of Previous Quit Attempts
|
7.58 Number of quit attempts
STANDARD_DEVIATION 13.51 • n=5 Participants
|
5.83 Number of quit attempts
STANDARD_DEVIATION 9.22 • n=7 Participants
|
6.12 Number of quit attempts
STANDARD_DEVIATION 13.90 • n=5 Participants
|
6.62 Number of quit attempts
STANDARD_DEVIATION 11.94 • n=4 Participants
|
|
Age started smoking
|
18.41 years
STANDARD_DEVIATION 5.15 • n=5 Participants
|
18.16 years
STANDARD_DEVIATION 60.16 • n=7 Participants
|
16.48 years
STANDARD_DEVIATION 3.43 • n=5 Participants
|
18.02 years
STANDARD_DEVIATION 5.44 • n=4 Participants
|
|
Fagerström Test for Nicotine Dependence (FTND) Total Score
|
4.74 score on a scale
STANDARD_DEVIATION 2.01 • n=5 Participants
|
4.65 score on a scale
STANDARD_DEVIATION 2.04 • n=7 Participants
|
5.34 score on a scale
STANDARD_DEVIATION 2.24 • n=5 Participants
|
4.79 score on a scale
STANDARD_DEVIATION 2.07 • n=4 Participants
|
|
Center for Epidemiologic Studies Depression Scale (CESD)
|
5.82 score on a scale
STANDARD_DEVIATION 5.37 • n=5 Participants
|
7.76 score on a scale
STANDARD_DEVIATION 7.07 • n=7 Participants
|
6.59 score on a scale
STANDARD_DEVIATION 6.17 • n=5 Participants
|
6.73 score on a scale
STANDARD_DEVIATION 6.27 • n=4 Participants
|
|
Positive and Negative Affect Schedule (PANAS)
PANAS Negative
|
14.56 units on a scale
STANDARD_DEVIATION 4.93 • n=5 Participants
|
14.93 units on a scale
STANDARD_DEVIATION 5.31 • n=7 Participants
|
14.44 units on a scale
STANDARD_DEVIATION 4.39 • n=5 Participants
|
14.70 units on a scale
STANDARD_DEVIATION 5.02 • n=4 Participants
|
|
Positive and Negative Affect Schedule (PANAS)
PANAS Positive
|
34.08 units on a scale
STANDARD_DEVIATION 7.64 • n=5 Participants
|
33.26 units on a scale
STANDARD_DEVIATION 7.43 • n=7 Participants
|
33.84 units on a scale
STANDARD_DEVIATION 8.80 • n=5 Participants
|
33.69 units on a scale
STANDARD_DEVIATION 7.72 • n=4 Participants
|
|
Wisconsin Smoking Withdrawal Scale (WSWS)
Anger
|
3.57 score on a scale
STANDARD_DEVIATION 2.25 • n=5 Participants
|
4.01 score on a scale
STANDARD_DEVIATION 2.48 • n=7 Participants
|
3.67 score on a scale
STANDARD_DEVIATION 23.8 • n=5 Participants
|
3.77 score on a scale
STANDARD_DEVIATION 2.37 • n=4 Participants
|
|
Wisconsin Smoking Withdrawal Scale (WSWS)
Anxiety
|
6.80 score on a scale
STANDARD_DEVIATION 2.74 • n=5 Participants
|
6.96 score on a scale
STANDARD_DEVIATION 2.99 • n=7 Participants
|
7.15 score on a scale
STANDARD_DEVIATION 2.76 • n=5 Participants
|
6.92 score on a scale
STANDARD_DEVIATION 2.84 • n=4 Participants
|
|
Wisconsin Smoking Withdrawal Scale (WSWS)
Concentration
|
3.80 score on a scale
STANDARD_DEVIATION 2.05 • n=5 Participants
|
3.84 score on a scale
STANDARD_DEVIATION 2.02 • n=7 Participants
|
3.69 score on a scale
STANDARD_DEVIATION 1.99 • n=5 Participants
|
3.80 score on a scale
STANDARD_DEVIATION 2.02 • n=4 Participants
|
|
Wisconsin Smoking Withdrawal Scale (WSWS)
Craving
|
9.40 score on a scale
STANDARD_DEVIATION 2.63 • n=5 Participants
|
9.86 score on a scale
STANDARD_DEVIATION 2.94 • n=7 Participants
|
9.87 score on a scale
STANDARD_DEVIATION 2.85 • n=5 Participants
|
9.67 score on a scale
STANDARD_DEVIATION 2.80 • n=4 Participants
|
|
Wisconsin Smoking Withdrawal Scale (WSWS)
Hunger
|
9.67 score on a scale
STANDARD_DEVIATION 3.39 • n=5 Participants
|
10.46 score on a scale
STANDARD_DEVIATION 3.50 • n=7 Participants
|
10.31 score on a scale
STANDARD_DEVIATION 3.44 • n=5 Participants
|
10.10 score on a scale
STANDARD_DEVIATION 3.46 • n=4 Participants
|
|
Wisconsin Smoking Withdrawal Scale (WSWS)
Sadness
|
4.38 score on a scale
STANDARD_DEVIATION 2.21 • n=5 Participants
|
4.76 score on a scale
STANDARD_DEVIATION 2.48 • n=7 Participants
|
4.55 score on a scale
STANDARD_DEVIATION 2.04 • n=5 Participants
|
4.57 score on a scale
STANDARD_DEVIATION 2.31 • n=4 Participants
|
|
Wisconsin Smoking Withdrawal Scale (WSWS)
Sleep
|
7.91 score on a scale
STANDARD_DEVIATION 4.04 • n=5 Participants
|
8.52 score on a scale
STANDARD_DEVIATION 4.48 • n=7 Participants
|
8.16 score on a scale
STANDARD_DEVIATION 4.47 • n=5 Participants
|
8.21 score on a scale
STANDARD_DEVIATION 4.29 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Affect
|
4.83 units on a scale
STANDARD_DEVIATION 2.00 • n=5 Participants
|
4.75 units on a scale
STANDARD_DEVIATION 2.01 • n=7 Participants
|
5.22 units on a scale
STANDARD_DEVIATION 1.97 • n=5 Participants
|
4.85 units on a scale
STANDARD_DEVIATION 2.00 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Affiliation
|
4.20 units on a scale
STANDARD_DEVIATION 2.13 • n=5 Participants
|
3.87 units on a scale
STANDARD_DEVIATION 2.22 • n=7 Participants
|
4.41 units on a scale
STANDARD_DEVIATION 2.42 • n=5 Participants
|
4.09 units on a scale
STANDARD_DEVIATION 2.22 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Automaticity
|
6.05 units on a scale
STANDARD_DEVIATION 2.02 • n=5 Participants
|
5.57 units on a scale
STANDARD_DEVIATION 2.17 • n=7 Participants
|
6.42 units on a scale
STANDARD_DEVIATION 2.11 • n=5 Participants
|
5.90 units on a scale
STANDARD_DEVIATION 2.11 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Cognitive
|
4.66 units on a scale
STANDARD_DEVIATION 2.09 • n=5 Participants
|
4.37 units on a scale
STANDARD_DEVIATION 2.17 • n=7 Participants
|
4.82 units on a scale
STANDARD_DEVIATION 2.05 • n=5 Participants
|
4.56 units on a scale
STANDARD_DEVIATION 2.12 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Control
|
6.17 units on a scale
STANDARD_DEVIATION 1.73 • n=5 Participants
|
6.32 units on a scale
STANDARD_DEVIATION 1.87 • n=7 Participants
|
6.51 units on a scale
STANDARD_DEVIATION 2.09 • n=5 Participants
|
6.28 units on a scale
STANDARD_DEVIATION 1.85 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Craving
|
6.11 units on a scale
STANDARD_DEVIATION 1.62 • n=5 Participants
|
5.95 units on a scale
STANDARD_DEVIATION 1.78 • n=7 Participants
|
6.53 units on a scale
STANDARD_DEVIATION 1.83 • n=5 Participants
|
6.11 units on a scale
STANDARD_DEVIATION 1.73 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Cue Exposure-Associative Processes
|
5.36 units on a scale
STANDARD_DEVIATION 1.82 • n=5 Participants
|
5.34 units on a scale
STANDARD_DEVIATION 2.02 • n=7 Participants
|
5.56 units on a scale
STANDARD_DEVIATION 1.74 • n=5 Participants
|
5.38 units on a scale
STANDARD_DEVIATION 1.90 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Social-Environmental Goads
|
4.00 units on a scale
STANDARD_DEVIATION 2.22 • n=5 Participants
|
3.77 units on a scale
STANDARD_DEVIATION 2.54 • n=7 Participants
|
4.25 units on a scale
STANDARD_DEVIATION 2.59 • n=5 Participants
|
3.94 units on a scale
STANDARD_DEVIATION 2.42 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Primary Dependence Motives
|
6.08 units on a scale
STANDARD_DEVIATION 1.53 • n=5 Participants
|
5.96 units on a scale
STANDARD_DEVIATION 1.64 • n=7 Participants
|
6.43 units on a scale
STANDARD_DEVIATION 1.75 • n=5 Participants
|
6.08 units on a scale
STANDARD_DEVIATION 1.61 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Secondary Dependence Motives
|
4.57 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 1.48 • n=7 Participants
|
4.71 units on a scale
STANDARD_DEVIATION 1.46 • n=5 Participants
|
4.51 units on a scale
STANDARD_DEVIATION 1.43 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Taste and Sensory Processes
|
5.52 units on a scale
STANDARD_DEVIATION 2.06 • n=5 Participants
|
5.29 units on a scale
STANDARD_DEVIATION 2.27 • n=7 Participants
|
5.50 units on a scale
STANDARD_DEVIATION 2.11 • n=5 Participants
|
5.41 units on a scale
STANDARD_DEVIATION 2.16 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Tolerance
|
6.01 units on a scale
STANDARD_DEVIATION 2.04 • n=5 Participants
|
6.01 units on a scale
STANDARD_DEVIATION 2.11 • n=7 Participants
|
6.26 units on a scale
STANDARD_DEVIATION 2.04 • n=5 Participants
|
6.04 units on a scale
STANDARD_DEVIATION 2.07 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Weight Control
|
3.40 units on a scale
STANDARD_DEVIATION 1.93 • n=5 Participants
|
3.29 units on a scale
STANDARD_DEVIATION 2.10 • n=7 Participants
|
3.18 units on a scale
STANDARD_DEVIATION 2.12 • n=5 Participants
|
3.32 units on a scale
STANDARD_DEVIATION 2.03 • n=4 Participants
|
|
Wisconsin Index of Smoking Dependence Motives (WISDM)
WISDM-Total
|
56.32 units on a scale
STANDARD_DEVIATION 14.11 • n=5 Participants
|
54.54 units on a scale
STANDARD_DEVIATION 15.66 • n=7 Participants
|
58.65 units on a scale
STANDARD_DEVIATION 15.53 • n=5 Participants
|
55.89 units on a scale
STANDARD_DEVIATION 15.03 • n=4 Participants
|
PRIMARY outcome
Timeframe: From quit date to 12 months.Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date.
Outcome measures
| Measure |
Varenicline + Bupropion
n=163 Participants
Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
|
Varenicline
n=166 Participants
Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
|
Placebo
n=56 Participants
Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
|
|---|---|---|---|
|
Smoking Abstinence at 12 Months
|
30 Participants
|
33 Participants
|
2 Participants
|
Adverse Events
Varenicline + Bupropion
Serious events: 8 serious events
Other events: 160 other events
Deaths: 0 deaths
Varenicline
Serious events: 4 serious events
Other events: 156 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline + Bupropion
n=163 participants at risk
Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
|
Varenicline
n=166 participants at risk
Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
|
Placebo
n=56 participants at risk
Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Eye disorders
Blurred vision
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Chest pain-cardiac
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Gastrointestinal disorders
Cholecystitis
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Delerium
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Depressive Symptoms
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Disturbance in attention
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Dizziness
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Eye disorders
Flashing lights
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Eye disorders
Floaters
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Heart failure
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Infection and infestation - Strep Throat
|
0.00%
0/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Infection and infestation - Tonsillitis
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Influenza
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.8%
3/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Reproductive system and breast disorders-other: uterine cancer
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Tachycardia/Palpitations
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Vascular disorders
Thromboembolic event
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
Other adverse events
| Measure |
Varenicline + Bupropion
n=163 participants at risk
Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day.
|
Varenicline
n=166 participants at risk
Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day.
|
Placebo
n=56 participants at risk
Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively.
|
|---|---|---|---|
|
Nervous system disorders
Slurred Speech
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Tremor
|
2.5%
4/163 • 12 months
|
1.2%
2/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Psychiatric disorders
Asthenia
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Abnormal Dreams
|
25.8%
42/163 • 12 months
|
34.3%
57/166 • 12 months
|
10.7%
6/56 • 12 months
|
|
Psychiatric disorders
Anxiety symptoms
|
23.3%
38/163 • 12 months
|
15.7%
26/166 • 12 months
|
17.9%
10/56 • 12 months
|
|
Psychiatric disorders
Depressive Symptoms
|
23.9%
39/163 • 12 months
|
24.1%
40/166 • 12 months
|
25.0%
14/56 • 12 months
|
|
Psychiatric disorders
Disturbance in attention
|
19.0%
31/163 • 12 months
|
16.3%
27/166 • 12 months
|
17.9%
10/56 • 12 months
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Insomnia
|
53.4%
87/163 • 12 months
|
36.1%
60/166 • 12 months
|
30.4%
17/56 • 12 months
|
|
Psychiatric disorders
Irritability
|
19.6%
32/163 • 12 months
|
25.3%
42/166 • 12 months
|
17.9%
10/56 • 12 months
|
|
Psychiatric disorders
Personality change
|
1.8%
3/163 • 12 months
|
1.8%
3/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders, other-emotional lability
|
0.61%
1/163 • 12 months
|
1.8%
3/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, Self-Injurious Behavior
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders - other, calmness
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders other-altered mental state
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders other-psychomotor retardation
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders, other- panic attack
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders, other-pressured speech
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders, other-Nicotine Dependence
|
4.9%
8/163 • 12 months
|
1.2%
2/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Psychiatric disorders
Psychiatric disorders-other (crying)
|
2.5%
4/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Psychiatric disorders
Restlessness
|
9.8%
16/163 • 12 months
|
8.4%
14/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Psychiatric disorders
Somnolence
|
10.4%
17/163 • 12 months
|
15.7%
26/166 • 12 months
|
10.7%
6/56 • 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/163 • 12 months
|
1.8%
3/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Psychiatric disorders
other Sleep Disturbances
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Renal and urinary disorders
Hematuria
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Renal and urinary disorders
Renal and urinary disorders-other hematospermia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Renal and urinary disorders
Renal calculi
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Renal and urinary disorders
Urinary frequency
|
5.5%
9/163 • 12 months
|
5.4%
9/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Renal and urinary disorders
Urine abnormality
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Renal and urinary disorders
Urine output decreased
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Reproductive system and breast disorders
Libido decreased
|
2.5%
4/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders other - Endometrial Hyperplasia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders-other: uterine cancer
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Coughing
|
14.7%
24/163 • 12 months
|
12.0%
20/166 • 12 months
|
8.9%
5/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, mucopurulent sputum
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other-Heavy Breathing
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, & mediastinal disorders, other-exacerbation of COPD
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
22.7%
37/163 • 12 months
|
20.5%
34/166 • 12 months
|
32.1%
18/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
9.2%
15/163 • 12 months
|
5.4%
9/166 • 12 months
|
12.5%
7/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.4%
12/163 • 12 months
|
6.0%
10/166 • 12 months
|
5.4%
3/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
2.5%
4/163 • 12 months
|
5.4%
9/166 • 12 months
|
5.4%
3/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.4%
17/163 • 12 months
|
7.8%
13/166 • 12 months
|
10.7%
6/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.61%
1/163 • 12 months
|
1.8%
3/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
4/163 • 12 months
|
0.60%
1/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical Procedures - Other, Eye Surgery
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Eye Surgery (II)
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Eye Surgery (III)
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, exploratory endoscopy
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Atrial flutter
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
4/163 • 12 months
|
2.4%
4/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Cardiac disorders
Conduction disorder
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Heart failure
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Cardiac disorders
Tachycardia/Palpitations
|
1.8%
3/163 • 12 months
|
4.2%
7/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
6/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Endocrine disorders
Endocrine disorders, other-excessive thirst
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Eye disorders
Blurred vision
|
4.9%
8/163 • 12 months
|
3.0%
5/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Eye disorders
Eye irritation
|
2.5%
4/163 • 12 months
|
7.2%
12/166 • 12 months
|
5.4%
3/56 • 12 months
|
|
Eye disorders
Flashing lights
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Floaters
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Eye disorders
Photosensitivity
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Eye disorders
eye disorders, other-eye twitching
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.5%
22/163 • 12 months
|
9.6%
16/166 • 12 months
|
5.4%
3/56 • 12 months
|
|
Gastrointestinal disorders
Anal fistula
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Blood in Stool
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Bloating
|
2.5%
4/163 • 12 months
|
3.0%
5/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Gastrointestinal disorders
Cecal hemorrhage
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
13.5%
22/163 • 12 months
|
11.4%
19/166 • 12 months
|
5.4%
3/56 • 12 months
|
|
Gastrointestinal disorders
Diverticulitis
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.5%
9/163 • 12 months
|
12.7%
21/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Gastrointestinal disorders
Dry mouth
|
17.2%
28/163 • 12 months
|
4.2%
7/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
11/163 • 12 months
|
6.6%
11/166 • 12 months
|
7.1%
4/56 • 12 months
|
|
Gastrointestinal disorders
Esophageal pain
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
12/163 • 12 months
|
6.0%
10/166 • 12 months
|
7.1%
4/56 • 12 months
|
|
Gastrointestinal disorders
Gallbladder obstruction
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Gastro-esophageal reflux disease
|
1.8%
3/163 • 12 months
|
1.8%
3/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal anastomotic leak
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.61%
1/163 • 12 months
|
1.2%
2/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other-softer stools
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other-increased salivation
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Hiccups
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
28.8%
47/163 • 12 months
|
38.6%
64/166 • 12 months
|
12.5%
7/56 • 12 months
|
|
Gastrointestinal disorders
Oral pain
|
1.2%
2/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Periodontal disease
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Toothache
|
4.3%
7/163 • 12 months
|
4.2%
7/166 • 12 months
|
5.4%
3/56 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
17/163 • 12 months
|
10.8%
18/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Gastrointestinal disorders
Appetite, decreased
|
12.3%
20/163 • 12 months
|
5.4%
9/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Appetite, increased
|
14.7%
24/163 • 12 months
|
17.5%
29/166 • 12 months
|
8.9%
5/56 • 12 months
|
|
General disorders
Chest Pain - non cardiac
|
2.5%
4/163 • 12 months
|
5.4%
9/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
General disorders
Dehydration
|
0.61%
1/163 • 12 months
|
3.0%
5/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
General disorders
Dizziness
|
17.8%
29/163 • 12 months
|
18.7%
31/166 • 12 months
|
17.9%
10/56 • 12 months
|
|
General disorders
Face Edema
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Fatigue
|
13.5%
22/163 • 12 months
|
13.3%
22/166 • 12 months
|
12.5%
7/56 • 12 months
|
|
General disorders
General Disorders and administration site conditions - Other, Hyperthermia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
General disorders and administration site conditions, other -blood from throat
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
General disorders and administration site conditions - Other, feeling speedy
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Influenza
|
17.2%
28/163 • 12 months
|
15.1%
25/166 • 12 months
|
19.6%
11/56 • 12 months
|
|
General disorders
Vertigo
|
1.2%
2/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Weight gain
|
11.0%
18/163 • 12 months
|
16.9%
28/166 • 12 months
|
5.4%
3/56 • 12 months
|
|
General disorders
Weight loss
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Immune system disorders
Allergy, Seasonal
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Immune system disorders
Immune system disorders - Shingles
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Bronchial infection
|
3.1%
5/163 • 12 months
|
1.8%
3/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Gum infection
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Infection
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Infections and infestations
Infection and infestation - Other - swollen lymph nodes
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Infection and infestation - Strep Throat
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Infection and infestation - Tonsillitis
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Infections & infestations, other-mycobacterium avium complex)
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Infections and infestations
Infections and infestations, other-fever blisters
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Infections and infestations, other-infection of R hand
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Kidney infection
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Lip infection
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Infections and infestations
Mucositis oral
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Nail infection
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Pharyngitis - bacterial
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Vaginal infection
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.61%
1/163 • 12 months
|
2.4%
4/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
5.5%
9/163 • 12 months
|
6.6%
11/166 • 12 months
|
7.1%
4/56 • 12 months
|
|
General disorders
Alanine aminotransferase increased
|
7.4%
12/163 • 12 months
|
7.2%
12/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
General disorders
Aspartate aminotransferase increased
|
6.7%
11/163 • 12 months
|
9.0%
15/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
General disorders
Bilirubin Increased
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Blood Bilirubin Increased
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Creatinine increased
|
10.4%
17/163 • 12 months
|
0.60%
1/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
General disorders
GGT increased
|
9.8%
16/163 • 12 months
|
6.0%
10/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
General disorders
Hepatobiliary disorders - Elevated GGT
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Investigations - Increased Alcohol Consumption
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Investigations, Other - Specify
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Investigations
Investigations-other (abnormal EKG)
|
0.00%
0/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
General disorders
Vascular disorders, other-hypercholesterolemia
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Metabolism and nutrition disorders
General disorders & administration site conditions - Diaphoresis
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.3%
7/163 • 12 months
|
1.2%
2/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders, other-low B12 levels
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
2/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Edema
|
9.8%
16/163 • 12 months
|
3.0%
5/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.5%
4/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Inflammation Gluteus
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Localized edema
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
27.6%
45/163 • 12 months
|
30.1%
50/166 • 12 months
|
28.6%
16/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.5%
9/163 • 12 months
|
2.4%
4/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
PERIPHERAL EDEMA
|
1.2%
2/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified (incl cysts & polyps) - other uterine fibroids
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, benign, malignant, & unspecified, (incl cysts & polyps) other-spot on cervix
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Aphonia
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Dizziness
|
17.8%
29/163 • 12 months
|
18.7%
31/166 • 12 months
|
17.9%
10/56 • 12 months
|
|
Nervous system disorders
Dysgeusia
|
12.3%
20/163 • 12 months
|
3.6%
6/166 • 12 months
|
3.6%
2/56 • 12 months
|
|
Nervous system disorders
FALL
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Headache
|
20.2%
33/163 • 12 months
|
21.1%
35/166 • 12 months
|
25.0%
14/56 • 12 months
|
|
Nervous system disorders
Nervous System disorders, other - Somniloquy
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Nervous system disorder other-jittery
|
1.2%
2/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Nervous system disorder, other-feeling heart beating
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Nervous system disorder, other-headrushes
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Nervous system disorders, other-Migraine
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Nervous system disorders, other-lightheadedness
|
0.00%
0/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Neurology - other
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.61%
1/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Nervous system disorders
Sensory disturbance
|
6.7%
11/163 • 12 months
|
7.2%
12/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.2%
2/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, tooth extraction
|
0.61%
1/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Tonsillectomy
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures - back surgery
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures -other, biopsy of prostate
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures, other-removal of facial cyst
|
0.00%
0/163 • 12 months
|
6.0%
10/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures, other-Removal of cyst
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Surgical and medical procedures
Surgical and medical procedures, other-root canal
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Vascular disorders
Flushing
|
0.00%
0/163 • 12 months
|
0.60%
1/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Vascular disorders
Hot flashes
|
4.9%
8/163 • 12 months
|
1.8%
3/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Vascular disorders
Hypertension
|
1.8%
3/163 • 12 months
|
2.4%
4/166 • 12 months
|
1.8%
1/56 • 12 months
|
|
Vascular disorders
Hypotension
|
0.61%
1/163 • 12 months
|
1.2%
2/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Vascular disorders
Thromboembolic event
|
0.61%
1/163 • 12 months
|
0.00%
0/166 • 12 months
|
0.00%
0/56 • 12 months
|
|
Vascular disorders
Vascular disorder, other-sweating
|
1.8%
3/163 • 12 months
|
1.2%
2/166 • 12 months
|
5.4%
3/56 • 12 months
|
Additional Information
Paul M. Cinciripini, BS,MS,PHD/Chair, Behavioral Science
UT MD Anderson Cancer Center
Phone: (713) 745-1868
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place