Trial Outcomes & Findings for The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers (NCT NCT01148537)
NCT ID: NCT01148537
Last Updated: 2012-09-03
Results Overview
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
132 participants
Primary outcome timeframe
Baseline to Day 13
Results posted on
2012-09-03
Participant Flow
02-Jul-2004 (first patient first visit) to 16-Dec-2004 (last patient last visit) at 1 site in the US (Austin, TX.)
During the initial screening visit, subjects were assessed for study eligibility through medical history, physical examination, vital signs, oxygen saturation, conventional 12-lead ECG, and laboratory tests. The investigator at the site examined the ECG telemetry to determine the subjects' eligibility.
Participant milestones
| Measure |
BTDS
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site.
BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 \* BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin.
|
Placebo
Matching placebo transdermal patches.
|
Moxifloxacin
Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
44
|
|
Overall Study
COMPLETED
|
41
|
44
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
3
|
Reasons for withdrawal
| Measure |
BTDS
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site.
BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 \* BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin.
|
Placebo
Matching placebo transdermal patches.
|
Moxifloxacin
Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
Baseline Characteristics
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
Moxifloxacin
n=44 Participants
Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
30.8 years
STANDARD_DEVIATION 9.46 • n=93 Participants
|
34.1 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
28.8 years
STANDARD_DEVIATION 9.69 • n=27 Participants
|
31.2 years
STANDARD_DEVIATION 10.1 • n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 13Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded.
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13
|
4.20 QTci (msec)
Standard Deviation 7.44
|
-1.71 QTci (msec)
Standard Deviation 6.92
|
PRIMARY outcome
Timeframe: Baseline to Day 13Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded.
Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13
|
4.17 QTci (msec)
Standard Deviation 7.22
|
-1.69 QTci (msec)
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: Baseline to Day 6Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded.
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
|
-1.06 QTci (msec)
Standard Deviation 6.17
|
-1.46 QTci (msec)
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: Baseline to Day 6Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded.
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6
|
6.26 QTci (msec)
Standard Deviation 6.11
|
-1.38 QTci (msec)
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: Baseline to Day 6 and Day 13Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded.
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
QTcB Day 6
|
-0.37 QTcB (msec)
Standard Deviation 7.18
|
-0.24 QTcB (msec)
Standard Deviation 8.15
|
|
The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
QTcB Day 13
|
6.31 QTcB (msec)
Standard Deviation 8.73
|
-0.86 QTcB (msec)
Standard Deviation 8.49
|
SECONDARY outcome
Timeframe: Baseline to Day 6 and Day 13Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded.
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
QTcB Day 6
|
8.13 QTcB (msec)
Standard Deviation 6.92
|
-0.09 QTcB (msec)
Standard Deviation 8.15
|
|
The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13
QTcB Day 13
|
6.55 QTcB (msec)
Standard Deviation 8.59
|
-0.84 QTcB (msec)
Standard Deviation 8.49
|
SECONDARY outcome
Timeframe: Baseline to Day 6 and Day 13Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded.
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
QTcF Day 6
|
-1.04 QTcF (msec)
Standard Deviation 7.32
|
-2.33 QTcF (msec)
Standard Deviation 8.07
|
|
The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
QTcF Day 13
|
4.13 QTcF (msec)
Standard Deviation 8.30
|
-1.88 QTcF (msec)
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: Baseline to Day 6 and Day 13Population: The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation. For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded.
QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values. Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec.
Outcome measures
| Measure |
BTDS
n=44 Participants
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 Participants
Matching placebo transdermal patches.
|
|---|---|---|
|
The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
QTcF Day 6
|
4.74 QTcF (msec)
Standard Deviation 7.21
|
-2.12 QTcF (msec)
Standard Deviation 8.07
|
|
The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13
QTcF Day 13
|
2.83 QTcF (msec)
Standard Deviation 7.81
|
-1.85 QTcF (msec)
Standard Deviation 7.67
|
Adverse Events
BTDS
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BTDS
n=44 participants at risk
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 participants at risk
Matching placebo transdermal patches.
|
Moxifloxacin
n=44 participants at risk
Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
|
|---|---|---|---|
|
Surgical and medical procedures
Abortion induced NOS
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
Other adverse events
| Measure |
BTDS
n=44 participants at risk
Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h.
|
Placebo
n=44 participants at risk
Matching placebo transdermal patches.
|
Moxifloxacin
n=44 participants at risk
Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Constipation
|
38.6%
17/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
5/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Nausea
|
59.1%
26/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Vomiting NOS
|
36.4%
16/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site burning
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site erythema
|
15.9%
7/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
11.4%
5/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site irritation
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site pruritus
|
22.7%
10/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
27.3%
12/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Fatigue
|
11.4%
5/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
6/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Disturbance in attention
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Dizziness
|
34.1%
15/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Headache
|
50.0%
22/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
18.2%
8/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Somnolence
|
13.6%
6/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Tremor
|
15.9%
7/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Psychiatric disorders
Abnormal dreams
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Psychiatric disorders
Affect lability
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Psychiatric disorders
Insomnia
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Renal and urinary disorders
Urinary retention
|
13.6%
6/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
13.6%
6/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
11.4%
5/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Skin and subcutaneous tissue disorders
Acne aggravated
|
6.8%
3/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
9.1%
4/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site paraesthesia
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Asthenia
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Rigors
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Thirst
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Abrasion NOS
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Poisoning NOS
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Metabolism and nutrition disorders
Appetite decreased NOS
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Psychiatric disorders
Bruxism
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Renal and urinary disorders
Dysuria
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
|
Vascular disorders
Flushing
|
4.5%
2/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
2.3%
1/44 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained by spontaneous reports, subject interview, and daily diary.
|
Additional Information
Executive Medical Director
Purdue Pharma L.P.
Phone: 800-733-1333
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60