Trial Outcomes & Findings for Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo. (NCT NCT03996694)
NCT ID: NCT03996694
Last Updated: 2021-02-05
Results Overview
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours
Results posted on
2021-02-05
Participant Flow
Participant milestones
| Measure |
ABCDEF
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
BCDEFA
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
CDEFAB
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
DEFABC
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
EFABCD
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
FABCDE
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
|---|---|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
3
|
3
|
4
|
3
|
3
|
3
|
|
First Intervention (1 Day)
COMPLETED
|
3
|
3
|
4
|
3
|
3
|
3
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Washout (7 Days)
STARTED
|
3
|
3
|
4
|
3
|
3
|
3
|
|
First Washout (7 Days)
COMPLETED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
First Washout (7 Days)
NOT COMPLETED
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Second Intervention (1 Day)
COMPLETED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Washout (7 Days)
STARTED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Second Washout (7 Days)
COMPLETED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Second Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (1 Day)
STARTED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Third Intervention (1 Day)
COMPLETED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Third Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Washout (7 Days)
STARTED
|
3
|
2
|
2
|
3
|
3
|
3
|
|
Third Washout (7 Days)
COMPLETED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Third Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Fourth Intervention (1 Day)
STARTED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fourth Intervention (1 Day)
COMPLETED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fourth Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Washout (7 Days)
STARTED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fourth Washout (7 Days)
COMPLETED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fourth Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fifth Intervention (1 Day)
STARTED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fifth Intervention (1 Day)
COMPLETED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fifth Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fifth Washout (7 Days)
STARTED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fifth Washout (7 Days)
COMPLETED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Fifth Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Sixth Intervention (1 Day)
STARTED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Sixth Intervention (1 Day)
COMPLETED
|
3
|
2
|
2
|
3
|
2
|
3
|
|
Sixth Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ABCDEF
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
BCDEFA
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
CDEFAB
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
DEFABC
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
EFABCD
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
FABCDE
Participants received a single dose of Treatment A, followed by a 7-day washout, then crossed over to the sequential treatments in the same manner
|
|---|---|---|---|---|---|---|
|
First Washout (7 Days)
positive urine drug screen
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Washout (7 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
First Washout (7 Days)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Third Washout (7 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
Baseline characteristics by cohort
| Measure |
All Arms
n=19 Participants
Subject disposition for all arms
|
|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 4.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hoursPopulation: The Completer Set consisted of all randomized subjects who completed all 6 treatment periods in the treatment phase with a valid VRH minute ventilation Emax measurement in each completed treatment period.
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
Outcome measures
| Measure |
Treatment A: Belbuca 300 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 300 µg: Belbuca 300 µg buccal film
|
Treatment B: Belbuca 600 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 600 µg: Belbuca 600 µg buccal film
|
Treatment C: Belbuca 900 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 900 µg: Belbuca 900 µg buccal film
|
Treatment D: Oxycodone 30 mg and Buccal Placebo
n=15 Participants
Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 30 mg: Oxycodone 30 mg capsule
|
Treatment E: Oxycodone 60 mg and Buccal Placebo
n=15 Participants
Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 60 mg: Oxycodone 60 mg capsule
|
Treatment F: Oral Placebo and Buccal Placebo
n=15 Participants
Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Placebo: placebo buccal film and oral placebo
|
|---|---|---|---|---|---|---|
|
Respiratory Drive
|
23957.34 mL/min
Standard Deviation 5554.061
|
22460.95 mL/min
Standard Deviation 8957.064
|
23626.79 mL/min
Standard Deviation 5025.767
|
21577.15 mL/min
Standard Deviation 806.552
|
17223.80 mL/min
Standard Deviation 4486.557
|
22645.74 mL/min
Standard Deviation 6965.108
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hoursPopulation: The Completer Set consisted of all randomized subjects who completed all 6 treatment periods in the treatment phase with a valid VRH minute ventilation Emax measurement in each completed treatment period.
Pupil diameter will be assessed by pupillometry predose and at multiple timepoints after completion of Belbuca, oxycodone hydrochloride, and placebo dosing.
Outcome measures
| Measure |
Treatment A: Belbuca 300 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 300 µg: Belbuca 300 µg buccal film
|
Treatment B: Belbuca 600 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 600 µg: Belbuca 600 µg buccal film
|
Treatment C: Belbuca 900 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 900 µg: Belbuca 900 µg buccal film
|
Treatment D: Oxycodone 30 mg and Buccal Placebo
n=15 Participants
Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 30 mg: Oxycodone 30 mg capsule
|
Treatment E: Oxycodone 60 mg and Buccal Placebo
n=15 Participants
Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 60 mg: Oxycodone 60 mg capsule
|
Treatment F: Oral Placebo and Buccal Placebo
n=15 Participants
Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Placebo: placebo buccal film and oral placebo
|
|---|---|---|---|---|---|---|
|
Pupil Diameter
4 hours Post
|
3.57 mm
Standard Deviation 0.720
|
3.25 mm
Standard Deviation 0.625
|
2.92 mm
Standard Deviation 0.653
|
3.51 mm
Standard Deviation 0.716
|
2.90 mm
Standard Deviation 0.634
|
4.89 mm
Standard Deviation 0.903
|
|
Pupil Diameter
Predose
|
4.93 mm
Standard Deviation 0.676
|
5.11 mm
Standard Deviation 1.063
|
4.91 mm
Standard Deviation 0.564
|
5.11 mm
Standard Deviation 0.922
|
4.82 mm
Standard Deviation 0.962
|
4.87 mm
Standard Deviation 1.150
|
|
Pupil Diameter
0.5 hours Post
|
4.65 mm
Standard Deviation 0.770
|
5.00 mm
Standard Deviation 1.020
|
4.91 mm
Standard Deviation 0.667
|
4.17 mm
Standard Deviation 1.041
|
3.48 mm
Standard Deviation 1.147
|
4.90 mm
Standard Deviation 1.041
|
|
Pupil Diameter
1 hour Post
|
4.49 mm
Standard Deviation 0.774
|
4.83 mm
Standard Deviation 0.973
|
4.32 mm
Standard Deviation 0.617
|
3.09 mm
Standard Deviation 0.741
|
2.77 mm
Standard Deviation 0.726
|
4.71 mm
Standard Deviation 1.091
|
|
Pupil Diameter
1.5 hours Post
|
4.42 mm
Standard Deviation 0.833
|
4.45 mm
Standard Deviation 0.838
|
3.85 mm
Standard Deviation 0.412
|
3.16 mm
Standard Deviation 0.693
|
2.81 mm
Standard Deviation 0.798
|
4.75 mm
Standard Deviation 1.127
|
|
Pupil Diameter
2 hours Post
|
3.89 mm
Standard Deviation 0.703
|
3.80 mm
Standard Deviation 0.698
|
3.27 mm
Standard Deviation 0.476
|
3.17 mm
Standard Deviation 0.721
|
2.7 mm
Standard Deviation 0.633
|
4.65 mm
Standard Deviation 0.952
|
|
Pupil Diameter
2.5 hours Post
|
3.87 mm
Standard Deviation 0.736
|
3.56 mm
Standard Deviation 0.676
|
3.15 mm
Standard Deviation 0.517
|
3.31 mm
Standard Deviation 0.688
|
2.87 mm
Standard Deviation 0.728
|
4.89 mm
Standard Deviation 1.033
|
|
Pupil Diameter
3 hours Post
|
3.67 mm
Standard Deviation 0.732
|
3.31 mm
Standard Deviation 0.688
|
2.99 mm
Standard Deviation 0.548
|
3.28 mm
Standard Deviation 0.722
|
2.82 mm
Standard Deviation 0.665
|
4.80 mm
Standard Deviation 0.963
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 2.5, 3 and 4 hoursPopulation: The Completer Set consisted of all randomized subjects who completed all 6 treatment periods in the treatment phase with a valid VRH minute ventilation Emax measurement in each completed treatment period.
Change in ratio of maximum decrease (Emax) in minute ventilation (mL/min) over maximum (Emax) end-tidal carbon dioxide (CO2, mmHg) after administration of Belbuca, oxycodone hydrochloride, and placebo.
Outcome measures
| Measure |
Treatment A: Belbuca 300 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 300 µg: Belbuca 300 µg buccal film
|
Treatment B: Belbuca 600 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 600 µg: Belbuca 600 µg buccal film
|
Treatment C: Belbuca 900 µg and Oral Placebo
n=15 Participants
Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 900 µg: Belbuca 900 µg buccal film
|
Treatment D: Oxycodone 30 mg and Buccal Placebo
n=15 Participants
Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 30 mg: Oxycodone 30 mg capsule
|
Treatment E: Oxycodone 60 mg and Buccal Placebo
n=15 Participants
Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 60 mg: Oxycodone 60 mg capsule
|
Treatment F: Oral Placebo and Buccal Placebo
n=15 Participants
Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Placebo: placebo buccal film and oral placebo
|
|---|---|---|---|---|---|---|
|
Change in Ratio of Minute Ventilation
|
591.74 ratio
Standard Deviation 135.568
|
536.28 ratio
Standard Deviation 195.123
|
576.76 ratio
Standard Deviation 115.782
|
518.81 ratio
Standard Deviation 162.565
|
411.88 ratio
Standard Deviation 100.259
|
546.09 ratio
Standard Deviation 179.371
|
SECONDARY outcome
Timeframe: 44 daysPopulation: There were N=19 subjects randomized in the BUP-401 study. Of the randomized subjects, N=19 subjects received at least one dose of study medication and were included in the Safety Set, 4 subjects discontinued the study before completing all six treatments in the crossover design.
Number of Participants with indicated Adverse Event (AE) in subjects receiving Belbuca, oxycodone hydrochloride, and placebo for 6 periods.
Outcome measures
| Measure |
Treatment A: Belbuca 300 µg and Oral Placebo
n=16 Participants
Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 300 µg: Belbuca 300 µg buccal film
|
Treatment B: Belbuca 600 µg and Oral Placebo
n=16 Participants
Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 600 µg: Belbuca 600 µg buccal film
|
Treatment C: Belbuca 900 µg and Oral Placebo
n=17 Participants
Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 900 µg: Belbuca 900 µg buccal film
|
Treatment D: Oxycodone 30 mg and Buccal Placebo
n=15 Participants
Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 30 mg: Oxycodone 30 mg capsule
|
Treatment E: Oxycodone 60 mg and Buccal Placebo
n=16 Participants
Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 60 mg: Oxycodone 60 mg capsule
|
Treatment F: Oral Placebo and Buccal Placebo
n=16 Participants
Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Placebo: placebo buccal film and oral placebo
|
|---|---|---|---|---|---|---|
|
Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.
Mild
|
7 participants
|
11 participants
|
10 participants
|
8 participants
|
12 participants
|
2 participants
|
|
Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.
Moderate
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Treatment A: Belbuca 300 µg and Oral Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment B: Belbuca 600 µg and Oral Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Treatment C: Belbuca 900 µg and Oral Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Treatment D: Oxycodone 30 mg and Buccal Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment E: Oxycodone 60 mg and Buccal Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Treatment F: Oral Placebo and Buccal Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Belbuca 300 µg and Oral Placebo
n=16 participants at risk
Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 300 µg: Belbuca 300 µg buccal film
|
Treatment B: Belbuca 600 µg and Oral Placebo
n=16 participants at risk
Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 600 µg: Belbuca 600 µg buccal film
|
Treatment C: Belbuca 900 µg and Oral Placebo
n=17 participants at risk
Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Belbuca 900 µg: Belbuca 900 µg buccal film
|
Treatment D: Oxycodone 30 mg and Buccal Placebo
n=15 participants at risk
Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 30 mg: Oxycodone 30 mg capsule
|
Treatment E: Oxycodone 60 mg and Buccal Placebo
n=16 participants at risk
Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Oxycodone 60 mg: Oxycodone 60 mg capsule
|
Treatment F: Oral Placebo and Buccal Placebo
n=16 participants at risk
Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.
Placebo: placebo buccal film and oral placebo
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Eye disorders
Visual Impairment
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
25.0%
4/16 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
23.5%
4/17 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
13.3%
2/15 • Number of events 2 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
31.2%
5/16 • Number of events 5 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
23.5%
4/17 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
13.3%
2/15 • Number of events 2 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
37.5%
6/16 • Number of events 6 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.7%
1/15 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
General disorders
Peripheral swelling
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
General disorders
Feeling of relaxation
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
General disorders
Feeling hot
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.7%
1/15 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Investigations
Lipase increased
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
25.0%
4/16 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
23.5%
4/17 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
20.0%
3/15 • Number of events 3 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
43.8%
7/16 • Number of events 7 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
25.0%
4/16 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
11.8%
2/17 • Number of events 2 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.7%
1/15 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
12.5%
2/16 • Number of events 2 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.7%
1/15 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Psychiatric disorders
Euphoric Mood
|
18.8%
3/16 • Number of events 3 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
18.8%
3/16 • Number of events 3 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
23.5%
4/17 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
26.7%
4/15 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
25.0%
4/16 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Psychiatric disorders
Irritability
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Pruritus
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
23.5%
4/17 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
26.7%
4/15 • Number of events 4 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
56.2%
9/16 • Number of events 9 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
12.5%
2/16 • Number of events 2 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
5.9%
1/17 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
6.2%
1/16 • Number of events 1 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/17 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/15 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
0.00%
0/16 • 44 days
N=19 subjects received at least one dose of study medication and included in the Safety Set, 4 subjects discontinued: 1 subject completed Treatment C - period 1 1 subject completed Treatment B-period 1 1 subject completed Treatment C-period 1 1 subject completed Treatments E, F, and A-periods 1, 2, and 3 Of the N=19 subjects in the safety set, N=15 completed all 6 treatments for completers There were N=16 in the Partial Completers Set (subjects who completed at least 2 treatments).
|
Additional Information
Todd Kunkel, PharmD Director, Scientific Communications
BioDelivery Sciences
Phone: 913-940-1789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place