Trial Outcomes & Findings for Telotristat Etiprate for Carcinoid Syndrome Therapy (NCT NCT02063659)
NCT ID: NCT02063659
Last Updated: 2018-02-26
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
76 participants
Primary outcome timeframe
First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)
Results posted on
2018-02-26
Participant Flow
Participants took part in the study at 31 investigative sites in Australia, Belgium, Canada, France, Germany, Israel, Netherlands, Spain, Sweden, United Kingdom, and the United States from 11 Mar 2014 to 29 Mar 2016.
Participants with Carcinoid Syndrome not adequately controlled by somatostatin analog (SSA) therapy were randomly assigned in a 1:1:1 ratio to receive placebo, 250 mg or 500 mg telotristat etiprate (LX1606) in the double-blind treatment period and were eligible to receive 500 mg telotristat etiprate in the open-label extension period.
Participant milestones
| Measure |
Placebo
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
Telotristat Etiprate Open-Label Extension
Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
|
|---|---|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
26
|
25
|
25
|
0
|
|
Double-Blind Treatment Period
COMPLETED
|
24
|
22
|
22
|
0
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
2
|
3
|
3
|
0
|
|
Open-Label Extension Period (OLE)
STARTED
|
0
|
0
|
0
|
67
|
|
Open-Label Extension Period (OLE)
COMPLETED
|
0
|
0
|
0
|
47
|
|
Open-Label Extension Period (OLE)
NOT COMPLETED
|
0
|
0
|
0
|
20
|
Reasons for withdrawal
| Measure |
Placebo
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
Telotristat Etiprate Open-Label Extension
Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
|
|---|---|---|---|---|
|
Double-Blind Treatment Period
Adverse Event
|
1
|
2
|
0
|
0
|
|
Double-Blind Treatment Period
Physician Decision
|
1
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Withdrawal of consent
|
0
|
1
|
3
|
0
|
|
Open-Label Extension Period (OLE)
Physician Decision
|
0
|
0
|
0
|
1
|
|
Open-Label Extension Period (OLE)
Withdrawal of Consent
|
0
|
0
|
0
|
9
|
|
Open-Label Extension Period (OLE)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Open-Label Extension Period (OLE)
Adverse Event
|
0
|
0
|
0
|
7
|
|
Open-Label Extension Period (OLE)
Reason not Specified
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Telotristat Etiprate for Carcinoid Syndrome Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=26 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 10.32 • n=99 Participants
|
63.6 years
STANDARD_DEVIATION 12.62 • n=107 Participants
|
62.7 years
STANDARD_DEVIATION 11.97 • n=206 Participants
|
62.8 years
STANDARD_DEVIATION 11.52 • n=7 Participants
|
|
Age, Customized
< 65 years
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Age, Customized
≥ 65 years
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
73 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Region of Enrollment
Israel
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Somatostatin Analog (SSA) Therapy Schedule at Study Entry
3-Week
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Somatostatin Analog (SSA) Therapy Schedule at Study Entry
4-Week
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Somatostatin Analog (SSA) Therapy Schedule at Study Entry
Not on SSA
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
SSA Therapy Name at Study Entry
Octreotide
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
SSA Therapy Name at Study Entry
Lanreotide
|
14 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
SSA Therapy Name at Study Entry
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
SSA Therapy Name at Study Entry
Not Applicable
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Childbearing Potential
Yes
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Childbearing Potential
No
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Childbearing Potential
Not Applicable
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Urinary 5-Hydroxyindoleacetic acid (5-HIAA) at Randomization
≤ ULN
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Urinary 5-Hydroxyindoleacetic acid (5-HIAA) at Randomization
> ULN
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Urinary 5-Hydroxyindoleacetic acid (5-HIAA) at Randomization
Unknown
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region
North America
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Region
Europe
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Region
Rest of the World
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Weight
|
76.38 kg
STANDARD_DEVIATION 16.959 • n=99 Participants
|
74.74 kg
STANDARD_DEVIATION 17.839 • n=107 Participants
|
76.69 kg
STANDARD_DEVIATION 26.188 • n=206 Participants
|
75.94 kg
STANDARD_DEVIATION 20.442 • n=7 Participants
|
|
Height
|
169.48 cm
STANDARD_DEVIATION 9.765 • n=99 Participants
|
169.74 cm
STANDARD_DEVIATION 10.025 • n=107 Participants
|
170.08 cm
STANDARD_DEVIATION 8.525 • n=206 Participants
|
169.76 cm
STANDARD_DEVIATION 9.327 • n=7 Participants
|
|
Baseline Body Mass Index (BMI)
|
26.28 kg/m^2
STANDARD_DEVIATION 4.364 • n=99 Participants
|
25.96 kg/m^2
STANDARD_DEVIATION 5.258 • n=107 Participants
|
26.21 kg/m^2
STANDARD_DEVIATION 9.213 • n=206 Participants
|
26.16 kg/m^2
STANDARD_DEVIATION 6.521 • n=7 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)Population: Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Outcome measures
| Measure |
Placebo
n=26 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
|
21 Participants
|
25 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.
u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=22 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=17 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=19 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
|
97.721 percentage change of mg/24 hours
Standard Deviation 397.0107
|
-33.164 percentage change of mg/24 hours
Standard Deviation 58.4754
|
-76.466 percentage change of mg/24 hours
Standard Deviation 17.3714
|
PRIMARY outcome
Timeframe: First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks)Population: Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
Outcome measures
| Measure |
Placebo
n=67 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period
|
61 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
|
0.050 counts/day
Standard Deviation 0.3263
|
-0.452 counts/day
Standard Deviation 0.6940
|
-0.595 counts/day
Standard Deviation 0.7240
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.
Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.
Outcome measures
| Measure |
Placebo
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points
|
0.006 score on a scale
Standard Deviation 0.4127
|
-0.196 score on a scale
Standard Deviation 0.7012
|
-0.597 score on a scale
Standard Deviation 0.8605
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.
Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
|
-0.333 counts/day
Standard Deviation 1.2203
|
-0.061 counts/day
Standard Deviation 0.9754
|
0.114 counts/day
Standard Deviation 2.0992
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.
Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
|
-0.063 score on a scale
Standard Deviation 0.7823
|
-0.234 score on a scale
Standard Deviation 0.9697
|
0.025 score on a scale
Standard Deviation 0.7744
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.
The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.
Outcome measures
| Measure |
Placebo
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points
|
-0.013 counts/day
Standard Deviation 0.1359
|
-0.065 counts/day
Standard Deviation 0.3542
|
0.006 counts/day
Standard Deviation 0.1030
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.The Placebo arm is not included because all participants in the Placebo arm were receiving SSA therapy at Baseline.
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=3 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=5 Participants
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
|---|---|---|---|
|
Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline
|
-0.906 counts/day
Standard Deviation 0.5925
|
-0.98 counts/day
Standard Deviation 1.154
|
—
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
250 mg Telotristat Etiprate
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
500 mg Telotristat Etiprate
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Telotristat Etiprate Open-Label Extension
Serious events: 17 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=26 participants at risk
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 participants at risk
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 participants at risk
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
Telotristat Etiprate Open-Label Extension
n=67 participants at risk
Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.8%
1/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
3.8%
1/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
3.8%
1/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Surgical and medical procedures
Urethral stent insertion
|
3.8%
1/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Cardiac disorders
Mitral valve incompetence
|
3.8%
1/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Investigations
Diagnostic procedure
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Surgical and medical procedures
Hepatectomy
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
3.0%
2/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Surgical and medical procedures
Small intestinal resection
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
3.0%
2/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Surgical and medical procedures
Antibiotic prophylaxis
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Surgical and medical procedures
Therapeutic embolisation
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Nervous system disorders
Syncope
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.5%
3/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.5%
3/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
1.5%
1/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
Other adverse events
| Measure |
Placebo
n=26 participants at risk
Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
250 mg Telotristat Etiprate
n=25 participants at risk
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
|
500 mg Telotristat Etiprate
n=25 participants at risk
Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.
|
Telotristat Etiprate Open-Label Extension
n=67 participants at risk
Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
4/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
32.0%
8/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
17.9%
12/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.2%
5/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
16.0%
4/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
13.4%
9/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
12.0%
3/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
20.9%
14/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
16.0%
4/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
12.0%
3/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
11.9%
8/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.5%
3/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
7.5%
5/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
12.0%
3/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
6.0%
4/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
General disorders
Fatigue
|
7.7%
2/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
12.0%
3/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
10.4%
7/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
General disorders
Asthenia
|
7.7%
2/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
10.4%
7/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
General disorders
Oedema peripheral
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
7.5%
5/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
12.0%
3/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
9.0%
6/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
12.0%
3/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Infections and infestations
Influenzae
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
9.0%
6/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Psychiatric disorders
Depressed mood
|
7.7%
2/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
8.0%
2/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Vascular disorders
Flushing
|
7.7%
2/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
12.0%
3/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
13.4%
9/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
2/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
4.0%
1/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
6.0%
4/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
6.0%
4/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
6.0%
4/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Investigations
Weight decreased
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
6.0%
4/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
6.0%
4/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
7.5%
5/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
7.5%
5/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
11.9%
8/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
10.4%
7/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
7.5%
5/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
6.0%
4/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
0.00%
0/25 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
7.5%
5/67 • First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any Confidential Information, proprietary information or patentable subject matter.
- Publication restrictions are in place
Restriction type: OTHER