Trial Outcomes & Findings for The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers (NCT NCT01999114)
NCT ID: NCT01999114
Last Updated: 2018-11-05
Results Overview
The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
328 participants
Primary outcome timeframe
Baseline to Day 6
Results posted on
2018-11-05
Participant Flow
First Subject First Visit: 15-March-2012; Last Subject Last Visit: 10-October-2012. The study was conducted at 1 medical/research site in the United States.
Healthy adult subjects
Participant milestones
| Measure |
BTDS
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
|
BTDS With Naltrexone
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Naltrexone
Naltrexone 50 mg tablets
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Moxifloxacin
Moxifloxacin 400-mg tablets
Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
|
Placebo
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
Placebos (for BTDS and for naltrexone and for moxifloxacin): Matching placebos
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
66
|
65
|
65
|
|
Overall Study
COMPLETED
|
58
|
59
|
61
|
62
|
61
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
5
|
3
|
4
|
Reasons for withdrawal
| Measure |
BTDS
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
|
BTDS With Naltrexone
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Naltrexone
Naltrexone 50 mg tablets
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Moxifloxacin
Moxifloxacin 400-mg tablets
Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
|
Placebo
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
Placebos (for BTDS and for naltrexone and for moxifloxacin): Matching placebos
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Administrative
|
0
|
0
|
1
|
1
|
2
|
Baseline Characteristics
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BTDS
n=66 Participants
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
|
BTDS With Naltrexone
n=66 Participants
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Naltrexone
n=66 Participants
Naltrexone 50 mg tablets
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Moxifloxacin
n=65 Participants
Moxifloxacin 400-mg tablets
Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
|
Placebo
n=65 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
Placebos (for TDS and for naltrexone and for moxifloxacin): Matching placebos
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
31.6 years
STANDARD_DEVIATION 8.97 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 10.03 • n=4 Participants
|
33.0 years
STANDARD_DEVIATION 10.48 • n=21 Participants
|
33.4 years
STANDARD_DEVIATION 9.80 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
127 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
201 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
204 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 6Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses.
The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=66 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=65 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
|
3.36 milliseconds (msec)
Interval 1.09 to 5.63
|
5.37 milliseconds (msec)
Interval 2.7 to 8.03
|
4.34 milliseconds (msec)
Interval 2.21 to 6.48
|
11.90 milliseconds (msec)
Interval 8.82 to 14.97
|
—
|
PRIMARY outcome
Timeframe: Baseline to Day 13Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses.
The effects of 40 mcg/hr buprenorphine (Day 13) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 40 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=64 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
|
9.16 msec
Interval 6.52 to 11.81
|
5.12 msec
Interval 2.26 to 7.97
|
1.81 msec
Interval -0.7 to 4.33
|
10.68 msec
Interval 7.06 to 14.3
|
—
|
PRIMARY outcome
Timeframe: Baseline to Day 17Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses.
The effects of 80 mcg/hr buprenorphine (Day 17) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 80 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=58 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=62 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=63 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)
|
11.46 msec
Interval 8.78 to 14.14
|
4.47 msec
Interval 1.71 to 7.23
|
1.50 msec
Interval -1.15 to 4.15
|
10.78 msec
Interval 7.2 to 14.35
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 6Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=66 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=65 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=64 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QTcF
|
-0.1 msec
Standard Deviation 5.9
|
2.9 msec
Standard Deviation 8.7
|
1.5 msec
Standard Deviation 4.6
|
6.9 msec
Standard Deviation 5.1
|
-0.8 msec
Standard Deviation 5.4
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QTcB
|
-0.3 msec
Standard Deviation 6.1
|
1.5 msec
Standard Deviation 6.6
|
0.9 msec
Standard Deviation 5.4
|
9.1 msec
Standard Deviation 5.2
|
0.5 msec
Standard Deviation 7.0
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
PR
|
4.7 msec
Standard Deviation 7.2
|
2.4 msec
Standard Deviation 5.0
|
2.1 msec
Standard Deviation 4.2
|
0.3 msec
Standard Deviation 6.1
|
0.6 msec
Standard Deviation 4.4
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QRS
|
0.4 msec
Standard Deviation 2.1
|
0.7 msec
Standard Deviation 1.9
|
0.6 msec
Standard Deviation 1.4
|
-0.2 msec
Standard Deviation 1.9
|
0.0 msec
Standard Deviation 1.5
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QT
|
0.3 msec
Standard Deviation 11.2
|
5.6 msec
Standard Deviation 22.1
|
2.6 msec
Standard Deviation 8.8
|
2.6 msec
Standard Deviation 11.9
|
-3.4 msec
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline to Day 6Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=66 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=65 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=64 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
Heart Rate (HR)
|
-0.1 bpm
Standard Deviation 3.8
|
-1.3 bpm
Standard Deviation 6.8
|
-0.5 bpm
Standard Deviation 2.9
|
2.0 bpm
Standard Deviation 4.1
|
1.3 bpm
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline to Day 13Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=64 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=62 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QTcF
|
5.0 msec
Standard Deviation 7.8
|
1.1 msec
Standard Deviation 9.6
|
-1.3 msec
Standard Deviation 6.2
|
5.6 msec
Standard Deviation 6.6
|
-1.6 msec
Standard Deviation 6.2
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QTcB
|
6.3 msec
Standard Deviation 8.8
|
-1.1 msec
Standard Deviation 8.0
|
-2.2 msec
Standard Deviation 6.8
|
8.0 msec
Standard Deviation 7.0
|
0.2 msec
Standard Deviation 7.2
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
PR
|
4.5 msec
Standard Deviation 8.7
|
4.4 msec
Standard Deviation 5.9
|
3.2 msec
Standard Deviation 9.1
|
1.3 msec
Standard Deviation 6.6
|
2.0 msec
Standard Deviation 5.5
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QRS
|
0.2 msec
Standard Deviation 2.8
|
0.9 msec
Standard Deviation 2.4
|
1.3 msec
Standard Deviation 2.0
|
-0.2 msec
Standard Deviation 2.6
|
0.3 msec
Standard Deviation 1.8
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QT
|
2.4 msec
Standard Deviation 16.0
|
5.5 msec
Standard Deviation 20.8
|
0.4 msec
Standard Deviation 11.3
|
0.9 msec
Standard Deviation 13.8
|
-5.1 msec
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline to Day 13Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=64 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=62 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
Heart Rate (HR)
|
1.3 bpm
Standard Deviation 5.9
|
-1.9 bpm
Standard Deviation 6.3
|
-0.8 bpm
Standard Deviation 3.7
|
2.3 bpm
Standard Deviation 5.0
|
1.6 bpm
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline to Day 17Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=58 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=62 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=63 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=62 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QT
|
6.1 msec
Standard Deviation 13.9
|
7.1 msec
Standard Deviation 17.1
|
0.8 msec
Standard Deviation 12.6
|
1.4 msec
Standard Deviation 11.9
|
-3.7 msec
Standard Deviation 11.7
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QTcF
|
9.0 msec
Standard Deviation 7.6
|
1.8 msec
Standard Deviation 8.6
|
-0.8 msec
Standard Deviation 7.4
|
6.7 msec
Standard Deviation 6.4
|
-0.4 msec
Standard Deviation 6.6
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QTcB
|
10.4 msec
Standard Deviation 9.0
|
-0.8 msec
Standard Deviation 8.7
|
-1.7 msec
Standard Deviation 7.9
|
9.3 msec
Standard Deviation 7.7
|
1.2 msec
Standard Deviation 7.6
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
PR
|
5.4 msec
Standard Deviation 8.9
|
5.8 msec
Standard Deviation 5.5
|
4.3 msec
Standard Deviation 5.7
|
3.8 msec
Standard Deviation 10.9
|
3.0 msec
Standard Deviation 5.3
|
|
QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval
QRS
|
0.4 msec
Standard Deviation 3.0
|
1.5 msec
Standard Deviation 2.3
|
1.3 msec
Standard Deviation 1.9
|
0.2 msec
Standard Deviation 2.8
|
0.6 msec
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline to Day 17Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=58 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=62 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=63 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=62 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
Heart Rate (HR)
|
1.3 bpm
Standard Deviation 4.9
|
-2.4 bpm
Standard Deviation 5.6
|
-0.8 bpm
Standard Deviation 3.9
|
2.5 bpm
Standard Deviation 4.4
|
1.5 bpm
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline to Day 6Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables: * Second degree heart block * Third degree heart block * Complete right bundle branch block (RBBB) * Complete left bundle branch block (LBBB) * ST segment changes (elevation and depression separately) * T-wave abnormalities (negative T waves only) * Myocardial infarction (MI) pattern * Any new abnormal U waves
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=66 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=65 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=64 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
ECG Morphology
New abnormal U waves
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New T wave (negative) inverted
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New ST segment depression changes
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
ECG Morphology
New ST segment elevation changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New complete RBBB & LBBB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New MI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New 2nd or 3rd degree heart block
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 13Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables: * Second degree heart block * Third degree heart block * Complete right bundle branch block (RBBB) * Complete left bundle branch block (LBBB) * ST segment changes (elevation and depression separately) * T-wave abnormalities (negative T waves only) * Myocardial infarction (MI) pattern * Any new abnormal U waves
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=63 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=64 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=62 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
ECG Morphology
New complete RBBB & LBBB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New abnormal U waves
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New T wave (negative) inverted
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
ECG Morphology
New ST segment depression changes
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
ECG Morphology
New ST segment elevation changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
ECG Morphology
New MI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New 2nd or 3rd degree heart block
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 17Population: The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.
Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables: * Second degree heart block * Third degree heart block * Complete right bundle branch block (RBBB) * Complete left bundle branch block (LBBB) * ST segment changes (elevation and depression separately) * T-wave abnormalities (negative T waves only) * Myocardial infarction (MI) pattern * Any new abnormal U waves
Outcome measures
| Measure |
BTDS Only (Placebo-corrected ΔΔQTcI)
n=58 Participants
BTDS 10 mcg/hr
|
BTDS With Naltrexone (Placebo-corrected ΔΔQTcI)
n=62 Participants
BTDS 10 mcg/hr and naltrexone 50 mg tablets
|
Naltrexone Alone (Placebo-corrected ΔΔQTcI)
n=63 Participants
Naltrexone 50 mg tablets
|
Moxifloxacin (Placebo-corrected ΔΔQTcI)
n=64 Participants
Moxifloxacin 400 mg tablet (positive control)
|
Placebo
n=62 Participants
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|---|---|---|---|---|---|
|
ECG Morphology
New abnormal U waves
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New T wave (negative) inverted
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
ECG Morphology
New ST segment depression changes
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
ECG Morphology
New ST segment elevation changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New complete RBBB & LBBB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New MI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
ECG Morphology
New 2nd or 3rd degree heart block
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
BTDS
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
BTDS With Naltrexone
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Naltrexone
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BTDS
n=66 participants at risk
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
|
BTDS With Naltrexone
n=66 participants at risk
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Naltrexone
n=66 participants at risk
Naltrexone 50 mg tablets
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Moxifloxacin
n=65 participants at risk
Moxifloxacin 400-mg tablets
Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
|
Placebo
n=65 participants at risk
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
Placebos (for TDS and for naltrexone and for moxifloxacin): Matching placebos
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Infrequent bowel movements
|
1.5%
1/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
Other adverse events
| Measure |
BTDS
n=66 participants at risk
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
|
BTDS With Naltrexone
n=66 participants at risk
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Naltrexone
n=66 participants at risk
Naltrexone 50 mg tablets
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
|
Moxifloxacin
n=65 participants at risk
Moxifloxacin 400-mg tablets
Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
|
Placebo
n=65 participants at risk
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
Placebos (for TDS and for naltrexone and for moxifloxacin): Matching placebos
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
13.6%
9/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
10.6%
7/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
12.1%
8/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
4/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.5%
3/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
13.6%
9/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
6.2%
4/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
4/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
9.1%
6/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
15.4%
10/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
6.2%
4/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Gastrointestinal disorders
Flatulence
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
9.1%
6/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.5%
3/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Gastrointestinal disorders
Haematochezia
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
53.0%
35/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
22.7%
15/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
24.2%
16/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
10.8%
7/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
15.4%
10/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
30/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
40.9%
27/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
28.8%
19/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.7%
5/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
12.3%
8/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Gastrointestinal disorders
Vomiting
|
24.2%
16/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
13.6%
9/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
10.6%
7/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
6.2%
4/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Application site erythema
|
9.1%
6/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
12.1%
8/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
12.3%
8/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Application site irritation
|
15.2%
10/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.7%
5/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
13.8%
9/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Application site pain
|
4.5%
3/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
10.6%
7/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.6%
3/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Application site papules
|
9.1%
6/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
10.6%
7/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
6.1%
4/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.6%
3/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Application site pruritus
|
18.2%
12/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
13.6%
9/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
19.7%
13/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
23.1%
15/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
12.3%
8/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Application site rash
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.6%
3/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Fatigue
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.5%
3/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Feeling drunk
|
6.1%
4/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.5%
3/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
General disorders
Feeling hot
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.6%
3/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Infections and infestations
Application site pustules
|
6.1%
4/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.1%
8/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Nervous system disorders
Dizziness
|
27.3%
18/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
12.1%
8/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
10.6%
7/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
6.2%
4/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Nervous system disorders
Headache
|
42.4%
28/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
30.3%
20/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
22.7%
15/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
16.9%
11/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
24.6%
16/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Nervous system disorders
Somnolence
|
10.6%
7/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Renal and urinary disorders
Dysuria
|
6.1%
4/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
4/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.0%
2/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
4.6%
3/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
1.5%
1/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
5/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
0.00%
0/66 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
3.1%
2/65 • Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60