Trial Outcomes & Findings for Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation (NCT NCT02859142)
NCT ID: NCT02859142
Last Updated: 2021-09-27
Results Overview
Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.
COMPLETED
PHASE4
122 participants
12 weeks
2021-09-27
Participant Flow
Participant milestones
| Measure |
Augmented Treatment
Participants received 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.
Drug: Chantix (Varenicline) Administered according to FDA approved package insert directions
Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks
Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
|
Standard Treatment
Participants received 12 weeks of Placebo along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.
Drug: Placebo (identical to Varenicline)
Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks
Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
57
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Augmented Treatment
Participants received 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.
Drug: Chantix (Varenicline) Administered according to FDA approved package insert directions
Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks
Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
|
Standard Treatment
Participants received 12 weeks of Placebo along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.
Drug: Placebo (identical to Varenicline)
Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks
Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Scheduling difficulties
|
0
|
3
|
Baseline Characteristics
One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
Baseline characteristics by cohort
| Measure |
Augmented Treatment
n=61 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=61 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 12.89 • n=61 Participants
|
44.02 years
STANDARD_DEVIATION 12.04 • n=61 Participants
|
44 years
STANDARD_DEVIATION 12.43 • n=122 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=61 Participants
|
29 Participants
n=61 Participants
|
55 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=61 Participants
|
32 Participants
n=61 Participants
|
67 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=61 Participants
|
2 Participants
n=61 Participants
|
8 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=61 Participants
|
59 Participants
n=61 Participants
|
114 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=61 Participants
|
1 Participants
n=61 Participants
|
2 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=61 Participants
|
30 Participants
n=61 Participants
|
54 Participants
n=122 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=61 Participants
|
28 Participants
n=61 Participants
|
56 Participants
n=122 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=61 Participants
|
2 Participants
n=61 Participants
|
9 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=122 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=61 Participants
|
61 participants
n=61 Participants
|
122 participants
n=122 Participants
|
|
Duration of smoking in years
|
25.5 years
STANDARD_DEVIATION 13.90 • n=61 Participants
|
24.9 years
STANDARD_DEVIATION 12.62 • n=61 Participants
|
25.2 years
STANDARD_DEVIATION 13.22 • n=122 Participants
|
|
Smoking days past month
|
27.84 days
STANDARD_DEVIATION 0.82 • n=61 Participants
|
27.41 days
STANDARD_DEVIATION 1.68 • n=61 Participants
|
27.6 days
STANDARD_DEVIATION 1.33 • n=122 Participants
|
|
Cigarettes per smoking day
|
11.84 cigarettes
STANDARD_DEVIATION 6.26 • n=61 Participants
|
11.66 cigarettes
STANDARD_DEVIATION 7.06 • n=61 Participants
|
11.75 cigarettes
STANDARD_DEVIATION 6.65 • n=122 Participants
|
|
Fagerström Test for Cigarette Dependence score
|
4.18 units on a scale
STANDARD_DEVIATION 2.36 • n=61 Participants
|
3.64 units on a scale
STANDARD_DEVIATION 2.42 • n=61 Participants
|
3.91 units on a scale
STANDARD_DEVIATION 2.40 • n=122 Participants
|
|
Expired carbon monoxide (CO)
|
16.67 ppm
STANDARD_DEVIATION 11.32 • n=61 Participants
|
17.54 ppm
STANDARD_DEVIATION 9.68 • n=61 Participants
|
17.11 ppm
STANDARD_DEVIATION 10.50 • n=122 Participants
|
|
Alcohol drinking days
|
17.54 days
STANDARD_DEVIATION 7.07 • n=61 Participants
|
18.90 days
STANDARD_DEVIATION 7.33 • n=61 Participants
|
18.22 days
STANDARD_DEVIATION 7.20 • n=122 Participants
|
|
Drinks per drinking day past month
|
5.41 drinks
STANDARD_DEVIATION 3.73 • n=61 Participants
|
6.08 drinks
STANDARD_DEVIATION 4.17 • n=61 Participants
|
5.75 drinks
STANDARD_DEVIATION 3.95 • n=122 Participants
|
|
Heavy drinking days past month
|
8.28 days
STANDARD_DEVIATION 5.99 • n=61 Participants
|
10.36 days
STANDARD_DEVIATION 8.77 • n=61 Participants
|
9.32 days
STANDARD_DEVIATION 7.55 • n=122 Participants
|
|
DSM5 Alcohol use disorder severity
None (0-1 symptoms)
|
24 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
28 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
52 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
|
DSM5 Alcohol use disorder severity
Mild (2-3 symptoms)
|
16 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
16 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
32 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
|
DSM5 Alcohol use disorder severity
Moderate (4-5 symptoms)
|
14 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
9 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
23 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
|
DSM5 Alcohol use disorder severity
Severe (6+ symptoms)
|
6 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
7 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
13 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.
Outcome measures
| Measure |
Augmented Treatment
n=61 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=61 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Change From Baseline Smoking Abstinence Rates at 12 Weeks
|
27 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study dropouts (i.e. lost to follow-up or voluntary withdrawals, N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.
Self-reported alcohol drinking days obtained via a past month Timeline Followback Calendar at 12 weeks
Outcome measures
| Measure |
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks
|
12.25 days
Standard Deviation 9.54
|
11.96 days
Standard Deviation 8.90
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Study dropouts (i.e. lost to follow-up or voluntary withdrawals, N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.
Self reported monthly alcohol drinking days obtained via a past month Timeline Followback Calendar at 26 weeks
Outcome measures
| Measure |
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks
|
12.73 days
Standard Deviation 9.06
|
11.44 days
Standard Deviation 7.91
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study dropouts (N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.
Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 12 weeks
Outcome measures
| Measure |
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks
|
5.02 days
Standard Deviation 7.44
|
5.58 days
Standard Deviation 7.54
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Study dropouts (i.e. lost to follow-up or voluntary withdrawals, N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.
Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 26 weeks
Outcome measures
| Measure |
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks
|
4.79 days
Standard Deviation 5.33
|
5.56 days
Standard Deviation 5.91
|
SECONDARY outcome
Timeframe: 26 weeksNumber of participants reporting smoking abstinence at 26 weeks from quit date via subjective and biologically verified reports.
Outcome measures
| Measure |
Augmented Treatment
n=61 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=61 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Change From Baseline Smoking Abstinence Rates at 26 Weeks
|
15 Participants
|
16 Participants
|
Adverse Events
Augmented Treatment
Standard Treatment
Serious adverse events
| Measure |
Augmented Treatment
n=61 participants at risk
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=61 participants at risk
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Psychiatric disorders
Self-injurious thoughts
|
1.6%
1/61 • Number of events 1 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
0.00%
0/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Nervous system disorders
Syncope
|
1.6%
1/61 • Number of events 1 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
0.00%
0/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
Other adverse events
| Measure |
Augmented Treatment
n=61 participants at risk
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling
Chantix (Varenicline): Administered according to FDA approved package insert directions
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
Standard Treatment
n=61 participants at risk
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling
Placebo (identical to Varenicline)
NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions
Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
55.7%
34/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
29.5%
18/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
9/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
4.9%
3/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Gastrointestinal disorders
Gas/flatulence
|
49.2%
30/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
27.9%
17/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Psychiatric disorders
Abnormal dreams
|
73.8%
45/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
49.2%
30/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Psychiatric disorders
Sleep problems
|
50.8%
31/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
24.6%
15/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Cardiac disorders
Increased heart rate
|
16.4%
10/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
9.8%
6/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Psychiatric disorders
Increased effects of alcohol
|
27.9%
17/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Psychiatric disorders
Suicidal thoughts
|
3.3%
2/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
1.6%
1/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Nervous system disorders
Dizziness
|
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Nervous system disorders
Headache
|
42.6%
26/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
23.0%
14/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
23.0%
14/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
14.8%
9/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
|
General disorders
Other
|
8.2%
5/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
6.6%
4/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place