Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension (NCT NCT01028651)
NCT ID: NCT01028651
Last Updated: 2017-02-24
Results Overview
The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH).
Recruitment status
COMPLETED
Target enrollment
13 participants
Primary outcome timeframe
24 Weeks
Results posted on
2017-02-24
Participant Flow
Participant milestones
| Measure |
Treprostinil Injection
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treprostinil Injection
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
Baseline characteristics by cohort
| Measure |
Treprostinil Injection
n=13 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|
|
Age, Continuous
|
55.8 Years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
|
Gender
Female
|
8 Participants
n=5 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: The total number of subjects enrolled and analyzed.
The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH).
Outcome measures
| Measure |
Treprostinil Injection
n=13 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.
Primary endpoint achieved
|
1 participants
|
—
|
|
Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.
Primary endpoint not achieved
|
12 participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All subjects with data available at Baseline and Week 24
The change in hemodynamic parameters (including systolic pulmonary arterial pressure \[PAPs\], diastolic pulmonary arterial pressure \[PAPd\], mean pulmonary arterial pressure \[mPAP\], and transpulmonary gradient \[TPG\]) was evaluated at rest from Baseline to Week 24. The median change in hemodynamic parameters from Baseline to Week 24 via right-heart catheterization (RHC) is presented.
Outcome measures
| Measure |
Treprostinil Injection
n=13 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Mean pulmonary arterial pressure (mmHg)
|
-3.8 mmHg
Interval -26.0 to 1.0
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Systolic pulmonary arterial pressure (mmHg)
|
-2.0 mmHg
Interval -46.0 to 1.0
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Diastolic pulmonary arterial pressure (mmHg)
|
-4.0 mmHg
Interval -22.0 to 1.0
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Mean right arterial pressure (mmHg)
|
-2.0 mmHg
Interval -9.0 to 5.0
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Mean systemic arterial pressure (mmHg)
|
-0.7 mmHg
Interval -28.0 to 34.7
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Systolic systemic arterial pressure (mmHg)
|
7.0 mmHg
Interval -44.0 to 94.0
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Diastolic systemic arterial pressure
|
0 mmHg
Interval -20.0 to 35.0
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Mean pulmonary capillary wedge pressure (mmHg)
|
0 mmHg
Interval -3.0 to 8.0
|
—
|
|
Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
Transpulmonary gradient (mmHg)
|
-6.8 mmHg
Interval -24.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All subjects with data available at Baseline and Week 24
The change in heart rate was evaluated at rest from Baseline to Week 24.
Outcome measures
| Measure |
Treprostinil Injection
n=13 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Heart Rate at Rest From Baseline to Week 24
|
0.5 beats/min
Interval -10.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All subjects with data available at Baseline and Week 24
The change in cardiac output was evaluated at rest from Baseline to Week 24. The median change in cardiac output from Baseline to Week 24 is presented.
Outcome measures
| Measure |
Treprostinil Injection
n=13 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Cardiac Output at Rest From Baseline to Week 24
|
0.3 L/min
Interval -6.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All subjects with data available at Baseline and Week 24
The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24.
Outcome measures
| Measure |
Treprostinil Injection
n=13 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24
Mixed venous oxygen saturation (%)
|
-2.0 percentage bound to hemoglobin
Interval -7.0 to 14.0
|
—
|
|
Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24
Arterial oxygen saturation (%)
|
0.5 percentage bound to hemoglobin
Interval -2.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All subjects with data available at Baseline and Week 24
The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24.
Outcome measures
| Measure |
Treprostinil Injection
n=13 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24
|
-0.3 Wood Units
Interval -8.2 to 1.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: All subjects with data available at Baseline and Weeks 12 and 24
The 6-Minute Walk Test was conducted at Screening, Baseline prior to starting study drug and at least 24 hours after the Screening test, and during the Treatment Phase at Weeks 12 and 24.
Outcome measures
| Measure |
Treprostinil Injection
n=11 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.
Change from Baseline to Week 12
|
54.5 Meters
Interval -48.0 to 133.0
|
—
|
|
Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.
Change from Baseline to Week 24
|
12.0 Meters
Interval -18.0 to 90.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: All subjects with data available at Baseline and Weeks 12 and 24.
Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.
Outcome measures
| Measure |
Treprostinil Injection
n=8 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
n=7 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24
Right atrium area (cm2)
|
-0.1 cm2
Interval -7.7 to 3.7
|
-1.7 cm2
Interval -12.0 to 10.0
|
|
Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24
Right ventricle area (cm2)
|
-1.0 cm2
Interval -11.0 to 2.2
|
-7.4 cm2
Interval -12.0 to 19.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: All subjects with data available at Baseline and Weeks 12 and 24.
Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.
Outcome measures
| Measure |
Treprostinil Injection
n=8 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
n=7 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24
|
-5.0 mm
Interval -45.0 to 2.0
|
3.0 mm
Interval -10.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: All subjects with data available at Baseline and Weeks 12 and 24.
Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.
Outcome measures
| Measure |
Treprostinil Injection
n=8 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
n=7 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24
|
-12 mmHg
Interval -28.0 to 11.0
|
-5.0 mmHg
Interval -38.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: All subjects with data available at Baseline and Weeks 12 and 24.
Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.
Outcome measures
| Measure |
Treprostinil Injection
n=8 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
n=7 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24
|
0.5 cm
Interval -0.5 to 0.9
|
0.1 cm
Interval -0.6 to 0.8
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: All subjects with data available at Baseline and Weeks 12 and 24.
The 36-item Short Form Survey (SF-36) is a health related quality of life instrument, which measures dimensions of physical and social roles and functioning, mental health, vitality, and pain. Items are scored on a 0 to 100 range so that the lowest scores represent the highest disability. The quality of life assessment was conducted at Baseline and Weeks 12 and 24 and the change from Baseline to Weeks 12 and 24 is presented.
Outcome measures
| Measure |
Treprostinil Injection
n=11 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
n=9 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Physical functioning
|
5.7 units on a scale
Interval -1.9 to 19.1
|
10.5 units on a scale
Interval 3.8 to 21.1
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
General health
|
4.5 units on a scale
Interval -2.4 to 12.8
|
3.6 units on a scale
Interval -2.4 to 18.1
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Role-Emotional
|
13.9 units on a scale
Interval -24.0 to 24.4
|
10.4 units on a scale
Interval -10.0 to 17.4
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Mental health
|
2.6 units on a scale
Interval -13.0 to 20.9
|
0 units on a scale
Interval -5.2 to 26.2
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Mental component summary
|
7.0 units on a scale
Interval -21.0 to 17.8
|
2.6 units on a scale
Interval -13.0 to 23.9
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Role-Physical
|
7.9 units on a scale
Interval -2.3 to 20.2
|
9.0 units on a scale
Interval 4.5 to 27.0
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Bodily pain
|
3.6 units on a scale
Interval -4.0 to 12.5
|
6.0 units on a scale
Interval -0.8 to 10.5
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Vitality
|
5.9 units on a scale
Interval -18.0 to 11.9
|
7.4 units on a scale
Interval -21.0 to 20.8
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Social functioning
|
7.5 units on a scale
Interval -5.0 to 15.0
|
0 units on a scale
Interval 0.0 to 25.1
|
|
Change in Quality of Life From Baseline to Weeks 12 and 24
Physical component summary
|
9.8 units on a scale
Interval -2.4 to 14.3
|
8.2 units on a scale
Interval 5.6 to 22.0
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: All subjects with data available at Baseline and Weeks 12 and 24.
NT-proBNP was assessed at Baseline, Weeks 12 and 24.
Outcome measures
| Measure |
Treprostinil Injection
n=9 Participants
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
Treprostinil Injection-Baseline to Week 24
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|---|
|
Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24
Change from Baseline to Week 12
|
-628 pg/mL
Interval -3854.0 to -29.0
|
—
|
|
Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24
Change from Baseline to Week 24
|
-478 pg/mL
Interval -1298.0 to 81.0
|
—
|
Adverse Events
Treprostinil Injection
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treprostinil Injection
n=13 participants at risk
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|
|
Hepatobiliary disorders
Chronic hepatic failure
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Renal and urinary disorders
Renal failure acute
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Death
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Nervous system disorders
Hepatic encephalopathy
|
7.7%
1/13 • Number of events 3 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Infusion site cellulitis
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Infusion site pain
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Multi-organ failure
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Renal and urinary disorders
Renal failure
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
Other adverse events
| Measure |
Treprostinil Injection
n=13 participants at risk
Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
|
|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.8%
4/13 • Number of events 5 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
4/13 • Number of events 6 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Urinary tract infection
|
23.1%
3/13 • Number of events 8 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Infusion site infection
|
23.1%
3/13 • Number of events 4 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Renal and urinary disorders
Renal failure acute
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • Number of events 3 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Ascites
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Nausea
|
76.9%
10/13 • Number of events 10 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Nervous system disorders
Headache
|
61.5%
8/13 • Number of events 10 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
53.8%
7/13 • Number of events 7 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Vomiting
|
53.8%
7/13 • Number of events 9 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Infusion site pain
|
38.5%
5/13 • Number of events 7 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
46.2%
6/13 • Number of events 6 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Oedema peripheral
|
15.4%
2/13 • Number of events 4 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.4%
2/13 • Number of events 2 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Abdominal distention
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Asthenia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Investigations
Blood uric acide increased
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Cardiac disorders
Cardiac failure congestive
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Surgical and medical procedures
Cataract operation
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Eye disorders
Conjunctival haemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Conjunctivitis
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Device leakage
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Gingival bleeding
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Hepatobiliary disorders
Hepatic lesion
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Infusion site erythema
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Infusion site vesicles
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Nervous system disorders
Lethargy
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Psychiatric disorders
Mental status changes
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Nervous system disorders
Migraine
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Oedema
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Investigations
Oxygen saturation decreased
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Surgical and medical procedures
Tooth extraction
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
7.7%
1/13 • Number of events 1 • Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
|
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