Trial Outcomes & Findings for Varenicline and Combined NRT for Smoking Cessation (NCT NCT02271919)
NCT ID: NCT02271919
Last Updated: 2026-04-24
Results Overview
7-day point-prevalence smoking abstinence (i.e., no self-reported smoking in the past 7 days), verified by expired carbon monoxide \<6 ppm (parts per millions)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
631 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
Arm 1: CNRT > Abstinent > CNRT
Those initially abstinent after 6 weeks of combined nicotine replacement therapy (CNRT) who continued on CNRT until week 12.
|
Arm 2: VAR > Abstinent > VAR
Those initially abstinent after 6 weeks of varenicline who continued on varenicline until week 12.
|
Arm 3: CNRT > Relapsed > VAR
Those who relapsed after 6 weeks of CNRT who were randomized to then receive varenicline until week 12.
|
Arm 4: CNRT > Relapsed > Increased CNRT
Those who relapsed after 6 weeks of CNRT who were randomized to then receive increased CNRT doses until week 12.
|
Arm 5: CNRT > Relapsed > CNRT
Those who relapsed after 6 weeks of CNRT who were randomized or assigned to continue the same dose of CNRT until week 12.
|
Arm 6: VAR > Relapsed > CNRT
Those who relapsed after 6 weeks of varenicline who were randomized to then receive CNRT until week 12.
|
Arm 7: VAR > Relapsed > Increased VAR
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12.
|
Arm 8: VAR > Relapsed > VAR
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
88
|
51
|
50
|
90
|
41
|
39
|
77
|
|
Overall Study
COMPLETED
|
54
|
84
|
50
|
48
|
53
|
35
|
34
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
1
|
2
|
37
|
6
|
5
|
32
|
Reasons for withdrawal
| Measure |
Arm 1: CNRT > Abstinent > CNRT
Those initially abstinent after 6 weeks of combined nicotine replacement therapy (CNRT) who continued on CNRT until week 12.
|
Arm 2: VAR > Abstinent > VAR
Those initially abstinent after 6 weeks of varenicline who continued on varenicline until week 12.
|
Arm 3: CNRT > Relapsed > VAR
Those who relapsed after 6 weeks of CNRT who were randomized to then receive varenicline until week 12.
|
Arm 4: CNRT > Relapsed > Increased CNRT
Those who relapsed after 6 weeks of CNRT who were randomized to then receive increased CNRT doses until week 12.
|
Arm 5: CNRT > Relapsed > CNRT
Those who relapsed after 6 weeks of CNRT who were randomized or assigned to continue the same dose of CNRT until week 12.
|
Arm 6: VAR > Relapsed > CNRT
Those who relapsed after 6 weeks of varenicline who were randomized to then receive CNRT until week 12.
|
Arm 7: VAR > Relapsed > Increased VAR
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12.
|
Arm 8: VAR > Relapsed > VAR
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
1
|
2
|
37
|
6
|
5
|
32
|
Baseline Characteristics
Varenicline and Combined NRT for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Arm 4: CNRT > Relapsed > Increased CNRT
n=50 Participants
Those who relapsed after 6 weeks of CNRT who were randomized to then receive increased CNRT doses until week 12.
|
Arm 5: CNRT > Relapsed > CNRT
n=90 Participants
Those who relapsed after 6 weeks of CNRT who were randomized or assigned to continue the same dose of CNRT until week 12.
|
Arm 6: VAR > Relapsed > CNRT
n=41 Participants
Those who relapsed after 6 weeks of varenicline who were randomized to then receive CNRT until week 12.
|
Arm 7: VAR > Relapsed > Increased VAR
n=39 Participants
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12.
|
Arm 8: VAR > Relapsed > VAR
n=77 Participants
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12.
|
Total
n=490 Participants
Total of all reporting groups
|
Arm 1: CNRT > Abstinent > CNRT
n=54 Participants
Those initially abstinent after 6 weeks of combined nicotine replacement therapy (CNRT) who continued on CNRT until week 12.
|
Arm 2: VAR > Abstinent > VAR
n=88 Participants
Those initially abstinent after 6 weeks of varenicline who continued on varenicline until week 12.
|
Arm 3: CNRT > Relapsed > VAR
n=51 Participants
Those who relapsed after 6 weeks of CNRT who were randomized to then receive varenicline until week 12.
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 11.7 • n=24 Participants
|
47.2 years
STANDARD_DEVIATION 11.7 • n=2 Participants
|
46.2 years
STANDARD_DEVIATION 11.4 • n=2 Participants
|
46.0 years
STANDARD_DEVIATION 10.9 • n=2 Participants
|
47.1 years
STANDARD_DEVIATION 11.2 • n=3 Participants
|
48.1 years
STANDARD_DEVIATION 11.3 • n=56 Participants
|
50.7 years
STANDARD_DEVIATION 11.0 • n=2 Participants
|
48.7 years
STANDARD_DEVIATION 11.3 • n=1 Participants
|
49.6 years
STANDARD_DEVIATION 10.8 • n=3 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=24 Participants
|
41 Participants
n=2 Participants
|
22 Participants
n=2 Participants
|
12 Participants
n=2 Participants
|
33 Participants
n=3 Participants
|
210 Participants
n=56 Participants
|
21 Participants
n=2 Participants
|
38 Participants
n=1 Participants
|
21 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=24 Participants
|
49 Participants
n=2 Participants
|
19 Participants
n=2 Participants
|
27 Participants
n=2 Participants
|
44 Participants
n=3 Participants
|
280 Participants
n=56 Participants
|
33 Participants
n=2 Participants
|
50 Participants
n=1 Participants
|
30 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=24 Participants
|
6 Participants
n=2 Participants
|
3 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
10 Participants
n=3 Participants
|
41 Participants
n=56 Participants
|
5 Participants
n=2 Participants
|
8 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=24 Participants
|
84 Participants
n=2 Participants
|
38 Participants
n=2 Participants
|
37 Participants
n=2 Participants
|
66 Participants
n=3 Participants
|
447 Participants
n=56 Participants
|
49 Participants
n=2 Participants
|
80 Participants
n=1 Participants
|
46 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants
|
4 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
12 Participants
n=56 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=24 Participants
|
24 Participants
n=2 Participants
|
12 Participants
n=2 Participants
|
17 Participants
n=2 Participants
|
17 Participants
n=3 Participants
|
129 Participants
n=56 Participants
|
14 Participants
n=2 Participants
|
19 Participants
n=1 Participants
|
15 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=24 Participants
|
54 Participants
n=2 Participants
|
25 Participants
n=2 Participants
|
21 Participants
n=2 Participants
|
48 Participants
n=3 Participants
|
302 Participants
n=56 Participants
|
36 Participants
n=2 Participants
|
57 Participants
n=1 Participants
|
27 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=24 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
13 Participants
n=56 Participants
|
0 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=24 Participants
|
6 Participants
n=2 Participants
|
3 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
7 Participants
n=3 Participants
|
32 Participants
n=56 Participants
|
3 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=24 Participants
|
90 participants
n=2 Participants
|
41 participants
n=2 Participants
|
39 participants
n=2 Participants
|
77 participants
n=3 Participants
|
490 participants
n=56 Participants
|
54 participants
n=2 Participants
|
88 participants
n=1 Participants
|
51 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 12 weeks7-day point-prevalence smoking abstinence (i.e., no self-reported smoking in the past 7 days), verified by expired carbon monoxide \<6 ppm (parts per millions)
Outcome measures
| Measure |
Arm 1: CNRT > Abstinent > CNRT
n=54 Participants
Those initially abstinent after 6 weeks of combined nicotine replacement therapy (CNRT) who continued on CNRT until week 12.
|
Arm 2: VAR > Abstinent > VAR
n=88 Participants
Those initially abstinent after 6 weeks of varenicline who continued on varenicline until week 12.
|
Arm 3: CNRT > Relapsed > VAR
n=51 Participants
Those who relapsed after 6 weeks of CNRT who were randomized to then receive varenicline until week 12.
|
Arm 4: CNRT > Relapsed > Increased CNRT
n=50 Participants
Those who relapsed after 6 weeks of CNRT who were randomized to then receive increased CNRT doses until week 12.
|
Arm 5: CNRT > Relapsed > CNRT
n=90 Participants
Those who relapsed after 6 weeks of CNRT who were randomized or assigned to continue the same dose of CNRT until week 12.
|
Arm 6: VAR > Relapsed > CNRT
n=41 Participants
Those who relapsed after 6 weeks of varenicline who were randomized to then receive CNRT until week 12.
|
Arm 7: VAR > Relapsed > Increased VAR
n=39 Participants
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12.
|
Arm 8: VAR > Relapsed > VAR
n=77 Participants
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12.
|
|---|---|---|---|---|---|---|---|---|
|
Smoking Abstinence
|
42 Participants
|
63 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
Adverse Events
Stage 1: CNRT
Serious events: 1 serious events
Other events: 131 other events
Deaths: 0 deaths
Stage 1: VAR
Serious events: 0 serious events
Other events: 151 other events
Deaths: 0 deaths
Stage 2: CRNT>Abstinent>CRNT
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Stage 2: CNRT>Relapsed>VAR
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Stage 2: CRNT>Relapsed>CNRT
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Stage 2: CNRT>Relapsed>High-dose CNRT
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Stage 2: VAR >Abstinent>VAR
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Stage 2: VAR>Relapsed>CNRT
Serious events: 2 serious events
Other events: 14 other events
Deaths: 2 deaths
Stage 2: VAR>Relapsed>VAR
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Stage 2: VAR>Relapsed>High-dose VAR
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: CNRT
n=245 participants at risk
Those assigned to 6 weeks of combined nicotine replacement therapy (CNRT) during Stage 1.
|
Stage 1: VAR
n=245 participants at risk
Those assigned to 6 weeks of varenicline during Stage 1.
|
Stage 2: CRNT>Abstinent>CRNT
n=54 participants at risk
Those initially abstinent after 6 weeks of combined nicotine replacement therapy (CNRT) who continued on CNRT until week 12 during Stage 2.
|
Stage 2: CNRT>Relapsed>VAR
n=51 participants at risk
Those who relapsed after 6 weeks of CNRT who were randomized to then receive varenicline until week 12 during Stage 2.
|
Stage 2: CRNT>Relapsed>CNRT
n=90 participants at risk
Those who relapsed after 6 weeks of CNRT who were randomized or assigned to continue the same dose of CNRT until week 12 during Stage 2.
|
Stage 2: CNRT>Relapsed>High-dose CNRT
n=50 participants at risk
Those who relapsed after 6 weeks of CNRT who were randomized to then receive increased CNRT doses until week 12 during Stage 2.
|
Stage 2: VAR >Abstinent>VAR
n=88 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12.
|
Stage 2: VAR>Relapsed>CNRT
n=41 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12.
|
Stage 2: VAR>Relapsed>VAR
n=77 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12 during Stage 2.
|
Stage 2: VAR>Relapsed>High-dose VAR
n=39 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12 during Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Bile Duct Stenosis
|
0.00%
0/245 • 16 weeks
|
0.00%
0/245 • 16 weeks
|
0.00%
0/54 • 16 weeks
|
0.00%
0/51 • 16 weeks
|
0.00%
0/90 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/88 • 16 weeks
|
2.4%
1/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
|
Investigations
GGT Increased
|
0.00%
0/245 • 16 weeks
|
0.00%
0/245 • 16 weeks
|
0.00%
0/54 • 16 weeks
|
0.00%
0/51 • 16 weeks
|
0.00%
0/90 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/88 • 16 weeks
|
2.4%
1/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
|
Vascular disorders
Thromboembolic Event
|
0.41%
1/245 • 16 weeks
|
0.00%
0/245 • 16 weeks
|
0.00%
0/54 • 16 weeks
|
0.00%
0/51 • 16 weeks
|
0.00%
0/90 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/88 • 16 weeks
|
0.00%
0/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
Other adverse events
| Measure |
Stage 1: CNRT
n=245 participants at risk
Those assigned to 6 weeks of combined nicotine replacement therapy (CNRT) during Stage 1.
|
Stage 1: VAR
n=245 participants at risk
Those assigned to 6 weeks of varenicline during Stage 1.
|
Stage 2: CRNT>Abstinent>CRNT
n=54 participants at risk
Those initially abstinent after 6 weeks of combined nicotine replacement therapy (CNRT) who continued on CNRT until week 12 during Stage 2.
|
Stage 2: CNRT>Relapsed>VAR
n=51 participants at risk
Those who relapsed after 6 weeks of CNRT who were randomized to then receive varenicline until week 12 during Stage 2.
|
Stage 2: CRNT>Relapsed>CNRT
n=90 participants at risk
Those who relapsed after 6 weeks of CNRT who were randomized or assigned to continue the same dose of CNRT until week 12 during Stage 2.
|
Stage 2: CNRT>Relapsed>High-dose CNRT
n=50 participants at risk
Those who relapsed after 6 weeks of CNRT who were randomized to then receive increased CNRT doses until week 12 during Stage 2.
|
Stage 2: VAR >Abstinent>VAR
n=88 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12.
|
Stage 2: VAR>Relapsed>CNRT
n=41 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12.
|
Stage 2: VAR>Relapsed>VAR
n=77 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized or assigned to continue the same dose of varenicline until week 12 during Stage 2.
|
Stage 2: VAR>Relapsed>High-dose VAR
n=39 participants at risk
Those who relapsed after 6 weeks of varenicline who were randomized to then receive increased varenicline doses until week 12 during Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
4.5%
11/245 • 16 weeks
|
4.5%
11/245 • 16 weeks
|
3.7%
2/54 • 16 weeks
|
2.0%
1/51 • 16 weeks
|
1.1%
1/90 • 16 weeks
|
2.0%
1/50 • 16 weeks
|
3.4%
3/88 • 16 weeks
|
2.4%
1/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
2.6%
1/39 • 16 weeks
|
|
Metabolism and nutrition disorders
Appetite Decreased
|
2.9%
7/245 • 16 weeks
|
4.9%
12/245 • 16 weeks
|
0.00%
0/54 • 16 weeks
|
3.9%
2/51 • 16 weeks
|
1.1%
1/90 • 16 weeks
|
4.0%
2/50 • 16 weeks
|
3.4%
3/88 • 16 weeks
|
0.00%
0/41 • 16 weeks
|
1.3%
1/77 • 16 weeks
|
5.1%
2/39 • 16 weeks
|
|
Metabolism and nutrition disorders
Appetite Increased
|
6.9%
17/245 • 16 weeks
|
8.6%
21/245 • 16 weeks
|
0.00%
0/54 • 16 weeks
|
3.9%
2/51 • 16 weeks
|
1.1%
1/90 • 16 weeks
|
2.0%
1/50 • 16 weeks
|
2.3%
2/88 • 16 weeks
|
0.00%
0/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
|
Psychiatric disorders
Depression
|
8.6%
21/245 • 16 weeks
|
8.6%
21/245 • 16 weeks
|
1.9%
1/54 • 16 weeks
|
5.9%
3/51 • 16 weeks
|
2.2%
2/90 • 16 weeks
|
10.0%
5/50 • 16 weeks
|
5.7%
5/88 • 16 weeks
|
4.9%
2/41 • 16 weeks
|
2.6%
2/77 • 16 weeks
|
7.7%
3/39 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.9%
12/245 • 16 weeks
|
6.1%
15/245 • 16 weeks
|
1.9%
1/54 • 16 weeks
|
5.9%
3/51 • 16 weeks
|
0.00%
0/90 • 16 weeks
|
2.0%
1/50 • 16 weeks
|
2.3%
2/88 • 16 weeks
|
0.00%
0/41 • 16 weeks
|
2.6%
2/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
|
Psychiatric disorders
Dreaming Abnormal
|
18.0%
44/245 • 16 weeks
|
20.0%
49/245 • 16 weeks
|
5.6%
3/54 • 16 weeks
|
3.9%
2/51 • 16 weeks
|
0.00%
0/90 • 16 weeks
|
4.0%
2/50 • 16 weeks
|
0.00%
0/88 • 16 weeks
|
7.3%
3/41 • 16 weeks
|
1.3%
1/77 • 16 weeks
|
2.6%
1/39 • 16 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
13/245 • 16 weeks
|
4.9%
12/245 • 16 weeks
|
1.9%
1/54 • 16 weeks
|
2.0%
1/51 • 16 weeks
|
2.2%
2/90 • 16 weeks
|
2.0%
1/50 • 16 weeks
|
3.4%
3/88 • 16 weeks
|
0.00%
0/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
7.7%
3/39 • 16 weeks
|
|
General disorders
Fatigue
|
6.1%
15/245 • 16 weeks
|
7.8%
19/245 • 16 weeks
|
1.9%
1/54 • 16 weeks
|
3.9%
2/51 • 16 weeks
|
1.1%
1/90 • 16 weeks
|
6.0%
3/50 • 16 weeks
|
2.3%
2/88 • 16 weeks
|
2.4%
1/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
5.1%
2/39 • 16 weeks
|
|
Nervous system disorders
Headache
|
5.7%
14/245 • 16 weeks
|
9.0%
22/245 • 16 weeks
|
9.3%
5/54 • 16 weeks
|
2.0%
1/51 • 16 weeks
|
1.1%
1/90 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
6.8%
6/88 • 16 weeks
|
4.9%
2/41 • 16 weeks
|
1.3%
1/77 • 16 weeks
|
2.6%
1/39 • 16 weeks
|
|
Psychiatric disorders
Insomnia
|
15.5%
38/245 • 16 weeks
|
17.6%
43/245 • 16 weeks
|
5.6%
3/54 • 16 weeks
|
7.8%
4/51 • 16 weeks
|
2.2%
2/90 • 16 weeks
|
20.0%
10/50 • 16 weeks
|
4.5%
4/88 • 16 weeks
|
2.4%
1/41 • 16 weeks
|
2.6%
2/77 • 16 weeks
|
2.6%
1/39 • 16 weeks
|
|
Psychiatric disorders
Irritability
|
5.7%
14/245 • 16 weeks
|
6.1%
15/245 • 16 weeks
|
1.9%
1/54 • 16 weeks
|
3.9%
2/51 • 16 weeks
|
2.2%
2/90 • 16 weeks
|
4.0%
2/50 • 16 weeks
|
1.1%
1/88 • 16 weeks
|
2.4%
1/41 • 16 weeks
|
0.00%
0/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.8%
24/245 • 16 weeks
|
26.9%
66/245 • 16 weeks
|
5.6%
3/54 • 16 weeks
|
13.7%
7/51 • 16 weeks
|
1.1%
1/90 • 16 weeks
|
4.0%
2/50 • 16 weeks
|
3.4%
3/88 • 16 weeks
|
7.3%
3/41 • 16 weeks
|
3.9%
3/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
20/245 • 16 weeks
|
5.7%
14/245 • 16 weeks
|
1.9%
1/54 • 16 weeks
|
0.00%
0/51 • 16 weeks
|
2.2%
2/90 • 16 weeks
|
6.0%
3/50 • 16 weeks
|
1.1%
1/88 • 16 weeks
|
9.8%
4/41 • 16 weeks
|
3.9%
3/77 • 16 weeks
|
0.00%
0/39 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
7.3%
18/245 • 16 weeks
|
3.3%
8/245 • 16 weeks
|
3.7%
2/54 • 16 weeks
|
2.0%
1/51 • 16 weeks
|
2.2%
2/90 • 16 weeks
|
2.0%
1/50 • 16 weeks
|
1.1%
1/88 • 16 weeks
|
4.9%
2/41 • 16 weeks
|
2.6%
2/77 • 16 weeks
|
2.6%
1/39 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place