Trial Outcomes & Findings for UW Quitting Using Intensive Treatment Study (QUITS) (NCT NCT03176784)
NCT ID: NCT03176784
Last Updated: 2023-01-23
Results Overview
Biochemically-confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1251 participants
Primary outcome timeframe
Assessed 52 weeks after quit date
Results posted on
2023-01-23
Participant Flow
Recruitment occurred via community outreach (e.g., social networking sites, radio, TV, newspaper). Interested respondents were called and screened for initial eligibility; those eligible attended a group orientation session that entailed: final eligibility assessment, written informed consent, baseline assessments, biochemical confirmation of smoking status, and randomization. Study visits were in Madison and Milwaukee, WI. First participant enrolled on 11/11/17; study completed on 7/9/20.
Participant milestones
| Measure |
Varenicline + Patch Standard Duration
Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
314
|
315
|
311
|
311
|
|
Overall Study
COMPLETED
|
209
|
202
|
198
|
241
|
|
Overall Study
NOT COMPLETED
|
105
|
113
|
113
|
70
|
Reasons for withdrawal
| Measure |
Varenicline + Patch Standard Duration
Standard Condition Varenicline: 0.5 mg pill once daily (QD) on Days -7 to -5; 0.5 mg pill twice daily (BID) Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
77
|
79
|
79
|
49
|
|
Overall Study
Withdrawal by Subject
|
28
|
34
|
34
|
21
|
Baseline Characteristics
UW Quitting Using Intensive Treatment Study (QUITS)
Baseline characteristics by cohort
| Measure |
Varenicline + Patch Standard Duration
n=314 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
n=315 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
Total
n=1251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
48.6 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
48.9 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
49.9 years
STANDARD_DEVIATION 11.5 • n=157 Participants
|
49.1 years
STANDARD_DEVIATION 11.9 • n=390 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=99 Participants
|
171 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
167 Participants
n=157 Participants
|
675 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
144 Participants
n=157 Participants
|
576 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
41 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
285 Participants
n=99 Participants
|
297 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
297 Participants
n=157 Participants
|
1164 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
46 Participants
n=390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
14 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
78 Participants
n=157 Participants
|
287 Participants
n=390 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=99 Participants
|
219 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
214 Participants
n=157 Participants
|
867 Participants
n=390 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
27 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
45 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
314 participants
n=99 Participants
|
315 participants
n=107 Participants
|
311 participants
n=206 Participants
|
311 participants
n=157 Participants
|
1251 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Assessed 52 weeks after quit dateBiochemically-confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Outcome measures
| Measure |
Varenicline + Patch Standard Duration
n=314 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
n=315 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
52-Week Point-Prevalence Abstinence
|
74 Participants
|
79 Participants
|
78 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Assessed 23 weeks after quit dateBiochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Outcome measures
| Measure |
Varenicline + Patch Standard Duration
n=314 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
n=315 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
23-Week Point-Prevalence Abstinence
|
74 Participants
|
66 Participants
|
82 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Assessed 52 weeks after quit dateBiochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 52 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Outcome measures
| Measure |
Varenicline + Patch Standard Duration
n=314 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
n=315 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
52-Week Prolonged Abstinence
|
47 Participants
|
55 Participants
|
57 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Assessed 23 weeks after quit dateBiochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) from week 2 post-quit through week 23 post-quit, confirmed with an exhaled carbon monoxide reading of less than or equal to 5 ppm.
Outcome measures
| Measure |
Varenicline + Patch Standard Duration
n=314 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
n=315 Participants
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
n=311 Participants
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
23-Week Prolonged Abstinence
|
66 Participants
|
72 Participants
|
73 Participants
|
65 Participants
|
Adverse Events
Varenicline + Patch Standard Duration
Serious events: 0 serious events
Other events: 194 other events
Deaths: 0 deaths
Varenicline Only Standard Duration
Serious events: 1 serious events
Other events: 164 other events
Deaths: 0 deaths
Varenicline + Patch Extended Duration
Serious events: 0 serious events
Other events: 159 other events
Deaths: 0 deaths
Varenicline Only Extended Duration
Serious events: 1 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline + Patch Standard Duration
n=305 participants at risk；n=314 participants at risk
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
n=300 participants at risk；n=315 participants at risk
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
n=295 participants at risk；n=311 participants at risk
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
n=307 participants at risk；n=311 participants at risk
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
General disorders
Anaphylaxis
|
0.00%
0/314 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
0.32%
1/315 • Number of events 1 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
0.00%
0/311 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
0.00%
0/311 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
|
General disorders
Allergic Reaction
|
0.00%
0/314 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
0.00%
0/315 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
0.00%
0/311 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
0.32%
1/311 • Number of events 1 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
Other adverse events
| Measure |
Varenicline + Patch Standard Duration
n=305 participants at risk；n=314 participants at risk
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Nicotine Patches:
Patches (Nicotine): 14 mg Patches for 2 weeks prequit and then 10 weeks post-quit, then 7 mg patches for Weeks 11 and 12; Placebo patches weeks 13-24
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline Only Standard Duration
n=300 participants at risk；n=315 participants at risk
Standard Condition Varenicline: 0.5 mg pill QD on Days -7 to -5; 0.5 mg pill BID Days -4 to -1; 1 mg pill BID Days 1 to Week 11; Placebo Pill weeks 12-23 BID
Standard Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
Placebo Pill: Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
|
Varenicline + Patch Extended Duration
n=295 participants at risk；n=311 participants at risk
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Nicotine Patches:
14 mg Patches for 2 weeks prequit and then weeks 1-22 post-quit, then 7 mg patches for Weeks 23 and 24 post-quit.
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Nicotine patch: 14 mg and 7 mg nicotine patches used. See arms for specific durations.
|
Varenicline Only Extended Duration
n=307 participants at risk；n=311 participants at risk
Extended Condition Varenicline: 0.5 mg pill QD on Days -7 to -5, 0.5 mg pill BID Days -4 to -1, and 1 mg pill BID Days 1 to Week 22
Extended Condition Placebo Patches:
Placebo patches for 2 weeks prequit and for weeks 1-24 post-quit
Varenicline: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Placebo Patch: Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
30.2%
92/305 • Number of events 92 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
24.0%
72/300 • Number of events 72 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
24.7%
73/295 • Number of events 73 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
30.9%
95/307 • Number of events 95 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
|
Nervous system disorders
Headache
|
3.9%
12/305 • Number of events 12 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
6.7%
20/300 • Number of events 20 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
5.4%
16/295 • Number of events 16 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
5.5%
17/307 • Number of events 17 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
|
Skin and subcutaneous tissue disorders
Itching/Hives
|
13.1%
40/305 • Number of events 40 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
3.0%
9/300 • Number of events 9 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
13.2%
39/295 • Number of events 39 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
4.6%
14/307 • Number of events 14 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
17.4%
53/305 • Number of events 53 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
11.3%
34/300 • Number of events 34 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
17.3%
51/295 • Number of events 51 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
9.8%
30/307 • Number of events 30 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
|
Psychiatric disorders
Insomnia
|
30.5%
93/305 • Number of events 93 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
29.3%
88/300 • Number of events 88 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
24.4%
72/295 • Number of events 72 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
27.0%
83/307 • Number of events 83 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
|
Psychiatric disorders
Changes in Mood
|
16.4%
50/305 • Number of events 50 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
16.0%
48/300 • Number of events 48 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
18.0%
53/295 • Number of events 53 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
16.3%
50/307 • Number of events 50 • Adverse event data were collected and tabulated for the first 12 weeks of treatment.
Some participants did not complete the adverse event assessments. The denominators used to calculate the percentage of participants reporting a given adverse event in each of the four conditions equal the number of participants responding to the adverse event assessment inquiry. Thus, the denominators do not equal the number of participants who started the study in each of the four conditions.
|
Additional Information
Stevens S. Smith, Ph.D.
University of Wisconsin School of Medicine and Public Health
Phone: 608-262-7563
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place