Trial Outcomes & Findings for Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® (NCT NCT01477333)
NCT ID: NCT01477333
Last Updated: 2023-12-27
Results Overview
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2023-12-27
Participant Flow
The recruitment period for this study was October 2011 to November 2013.
Participant milestones
| Measure |
UT-15C SR BID
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
UT-15C SR BID
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Clinical Deterioration
|
1
|
Baseline Characteristics
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
Baseline characteristics by cohort
| Measure |
UT-15C SR BID
n=18 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
|
Age, Continuous
|
51.3 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population with data available at Baseline and Week 24.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm).
Outcome measures
| Measure |
UT-15C SR BID
n=15 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Systolic systemic arterial pressure (mmHg)
|
-2.0 mmHg
Interval -22.0 to 21.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Diastolic systemic arterial pressure (mmHg)
|
0 mmHg
Interval -20.0 to 18.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Mean systemic arterial pressure (mmHg)
|
-1.0 mmHg
Interval -29.0 to 18.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Systolic pulmonary arterial pressure (mmHg)
|
3.0 mmHg
Interval -51.0 to 12.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Diastolic pulmonary arterial pressure (mmHg)
|
0 mmHg
Interval -16.0 to 10.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Mean pulmonary arterial pressure (mmHg)
|
0 mmHg
Interval -26.0 to 10.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Mean right atrial pressure (mmHg)
|
0 mmHg
Interval -9.0 to 6.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters From Baseline to Week 24.
Mean pulmonary capillary wedge pressure (mmHg)
|
-1.0 mmHg
Interval -15.0 to 8.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population with data available at Baseline and Week 24.
Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Outcome measures
| Measure |
UT-15C SR BID
n=15 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24.
|
4.00 beats/min
Interval -29.0 to 25.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population with data available at Baseline and Week 24.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2).
Outcome measures
| Measure |
UT-15C SR BID
n=15 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.
Arterial oxygen saturation (%)
|
1.0 percentage bound to hemoglobin
Interval -5.0 to 5.0
|
—
|
—
|
—
|
|
Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.
Mixed venous oxygen saturation (%)
|
0 percentage bound to hemoglobin
Interval -9.0 to 4.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population with data available at Baseline and Week 24.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Outcome measures
| Measure |
UT-15C SR BID
n=15 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24.
|
0 L/min
Interval -1.0 to 4.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population with data available at Baseline and Week 24.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included cardiac index (CI).
Outcome measures
| Measure |
UT-15C SR BID
n=15 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24.
|
0 L/min/m^2
Interval 0.0 to 1.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population with data available at Baseline and Week 24.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI).
Outcome measures
| Measure |
UT-15C SR BID
n=15 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24.
|
0.2 dyn*s/cm^5*m^2
Interval -10.0 to 7.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12, and 24Population: Intent-to-treat population with data available at Baseline and Week 24.
The 6MWT was conducted at Baseline, 2 to 4 hours after the last Tyvaso dose, and prior to first dose of UT-15C SR. The 6MWT was also performed at Weeks 4, 12, and 24, or at the time of premature termination of study drug if prior to the Week 24 visit.
Outcome measures
| Measure |
UT-15C SR BID
n=18 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.
Week 4
|
20.5 Meters
Interval -111.0 to 119.0
|
—
|
—
|
—
|
|
Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.
Week 12
|
12.4 Meters
Interval -70.0 to 101.0
|
—
|
—
|
—
|
|
Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.
Week 24
|
14.9 Meters
Interval -178.0 to 101.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Clinical worsening was assessed continuously from Baseline through each subject's last study visitPopulation: Intent-to-treat population with data available at Baseline and Week 24.
Clinical worsening was assessed continuously from Baseline through each subject's last study visit. Clinical worsening was defined as the occurrence of any one or more of the following: death (all causes), hospitalization as a result of worsening pulmonary arterial hypertension (PAH), and initiation of a parenteral prostacyclin.
Outcome measures
| Measure |
UT-15C SR BID
n=18 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
Time to Clinical Worsening Over the Treatment Period.
|
234 Days
Standard Deviation 200.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, and 24Population: Intent-to-treat population with data available at Baseline and Week 24.
The WHO functional classification for pulmonary hypertension was assessed at Baseline prior to starting UT-15C SR, Weeks 4, 8, 12, and 24, or at the time of premature termination if prior to Week 24. The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment).
Outcome measures
| Measure |
UT-15C SR BID
n=18 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
n=18 Participants
UT-15C SR BID
|
Class III to Class II
n=18 Participants
UT-15C SR BID
|
Class III to Class III
n=18 Participants
UT-15C SR BID
|
|---|---|---|---|---|
|
Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.
Week 4
|
8 participants
|
1 participants
|
0 participants
|
9 participants
|
|
Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.
Week 8
|
6 participants
|
3 participants
|
2 participants
|
7 participants
|
|
Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.
Week 12
|
9 participants
|
0 participants
|
1 participants
|
8 participants
|
|
Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.
Week 24
|
7 participants
|
1 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: Intent-to-treat population with data available at Baseline and Week 24.
NT-proBNP was assessed at Baseline prior to starting UT-15C SR, Weeks 12 and 24, or at the time of premature termination if prior to Week 24. Blood for NT-proBNP assessment was collected before the 6MWT was conducted.
Outcome measures
| Measure |
UT-15C SR BID
n=16 Participants
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
Class II to Class III
UT-15C SR BID
|
Class III to Class II
UT-15C SR BID
|
Class III to Class III
UT-15C SR BID
|
|---|---|---|---|---|
|
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period.
Week 12
|
-99 pg/mL
Standard Deviation 295
|
—
|
—
|
—
|
|
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period.
Week 24
|
144 pg/mL
Standard Deviation 464
|
—
|
—
|
—
|
Adverse Events
UT-15C SR BID
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UT-15C SR BID
n=18 participants at risk
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Renal and urinary disorders
Renal failure acute
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
Other adverse events
| Measure |
UT-15C SR BID
n=18 participants at risk
UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
61.1%
11/18 • Number of events 11 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Nervous system disorders
Headache
|
77.8%
14/18 • Number of events 14 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Nausea
|
66.7%
12/18 • Number of events 12 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Vascular disorders
Flushing
|
44.4%
8/18 • Number of events 8 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Fatigue
|
33.3%
6/18 • Number of events 6 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.8%
5/18 • Number of events 5 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
4/18 • Number of events 4 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Edema peripheral
|
22.2%
4/18 • Number of events 5 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
4/18 • Number of events 4 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
3/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Chest discomfort
|
16.7%
3/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Chest pain
|
16.7%
3/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Vascular disorders
Hypotension
|
16.7%
3/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
3/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
3/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Blood urea increased
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Bronchitis
|
11.1%
2/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Cardiac disorders
Palpitations
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Nervous system disorders
Presyncope
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Sinusitis
|
11.1%
2/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Nervous system disorders
Syncope
|
11.1%
2/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
2/18 • Number of events 3 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Cardiac disorders
Atrial fibrillatioin
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Atypical pneumonia
|
5.6%
1/18 • Number of events 2 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Blood pressure increased
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Duodenal polyp
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Nervous system disorders
Dysguesia
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea paroxysmal nocturnal
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Injury, poisoning and procedural complications
Eye burns
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Face edema
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Hematocrit decreased
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Renal and urinary disorders
Hematuria
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Hemoglobin decreased
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Local swelling
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Lower respiratory tract infection
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Edema
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Cardiac disorders
Pericarditis
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Red blood cell count decreased
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Renal and urinary disorders
Renal cyst
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Psychiatric disorders
Restlessness
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Cardiac disorders
Sinus bradycardia
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Weight decreased
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Investigations
Weight increased
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Psychiatric disorders
Affect lability
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Vascular disorders
Hot flush
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
|
Infections and infestations
Respiratory tract infection
|
5.6%
1/18 • Number of events 1 • Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed, except as provided below. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
- Publication restrictions are in place
Restriction type: OTHER