Trial Outcomes & Findings for Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID) (NCT NCT02847260)
NCT ID: NCT02847260
Last Updated: 2017-10-17
Results Overview
Successful completion was defined as completion of the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
39 participants
Primary outcome timeframe
Baseline to week 16
Results posted on
2017-10-17
Participant Flow
Participant milestones
| Measure |
Remodulin
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Remodulin
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Clinical Deterioration
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)
Baseline characteristics by cohort
| Measure |
Remodulin
n=39 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 16Successful completion was defined as completion of the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.
Outcome measures
| Measure |
Remodulin
n=39 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Number of Participants With Successful Completion of the 16 Week Treatment Period.
|
32 participants
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.
The purpose of the six minute walk test (6MWT) was to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance \<500 meters suggests considerable exercise limitation; Distance 500 - 800 meters suggests moderate limitation; Distance \>800 meters (with no rests) suggests mild or no limitation.
Outcome measures
| Measure |
Remodulin
n=30 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Change From Baseline in Six Minute Walk Distance at Week 16.
|
11.5 meters
Interval -62.0 to 246.0
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.
The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the 6MWT. The Borg dyspnea score was assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).
Outcome measures
| Measure |
Remodulin
n=30 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 16
|
0.0 units on a scale
Interval -4.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline to week 16The level of this biomarker of the (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 16.
Outcome measures
| Measure |
Remodulin
n=32 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 16.
|
-182.0 pg/mL
Interval -18396.0 to 9629.0
|
SECONDARY outcome
Timeframe: Baseline to week 16The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.
Outcome measures
| Measure |
Remodulin
n=32 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
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Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.
II to II
|
4 Participants
|
|
Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.
II to III
|
1 Participants
|
|
Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.
III to II
|
8 Participants
|
|
Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.
III to III
|
18 Participants
|
|
Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.
III to IV
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Scores could not be tabulated for one subject due to missing responses to individual questions
The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, negative change scores indicate improvements.
Outcome measures
| Measure |
Remodulin
n=31 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 16.
CAMPHOR total score
|
-5.0 units on a scale
Interval -44.0 to 13.0
|
|
Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 16.
Quality of life
|
-1.0 units on a scale
Interval -13.0 to 7.0
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SECONDARY outcome
Timeframe: Baseline to week 16Population: Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.
Pulmonary hypertension, an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by Swan-Ganz right heart catheterization. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.
Outcome measures
| Measure |
Remodulin
n=29 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
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Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm).
RAPm (mmHg)
|
0.3 mmHG
Standard Deviation 5.6
|
|
Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm).
PAPm (mmHg)
|
-3.2 mmHG
Standard Deviation 10.5
|
|
Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm).
PCWPm (mmHg)
|
-0.3 mmHG
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.
Cardiac Index (CI) relates the cardiac output (CO) to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.
Outcome measures
| Measure |
Remodulin
n=29 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
|
Change From Baseline to Week 16 in Hemodynamic Parameters: Cardiac Index (CI) (L/Min/m^2)
|
0.4 L/min/m^2
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.
Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular load. The PVRI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization.
Outcome measures
| Measure |
Remodulin
n=29 Participants
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
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|---|---|
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Change From Baseline to Week 16 in HemodynamicParameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)
|
-3.5 mmHg*min*m^2/L
Standard Deviation 4.5
|
Adverse Events
Remodulin
Serious events: 11 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remodulin
n=39 participants at risk
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
|
|---|---|
|
Cardiac disorders
Right Ventricular Failure (RVF)
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Diarrhoea,
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Skin and subcutaneous tissue disorders
Infusion Site Pain
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Rib Fracture
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Fatigue
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Renal and urinary disorders
Renal Impairment
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Infections and infestations
Bronchitis
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Infections and infestations
Pneumonia, bacterial
|
2.6%
1/39 • Number of events 1 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
Other adverse events
| Measure |
Remodulin
n=39 participants at risk
Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively.
|
|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Cardiac disorders
Angina pectoris
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Cardiac disorders
Tachycardia
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Ear and labyrinth disorders
Vertigo
|
20.5%
8/39 • Number of events 8 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
71.8%
28/39 • Number of events 28 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
18/39 • Number of events 18 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
15/39 • Number of events 16 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Infusion Site Pain
|
92.3%
36/39 • Number of events 37 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Infusion Site Erythema
|
25.6%
10/39 • Number of events 10 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Oedema Peripheral
|
15.4%
6/39 • Number of events 6 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Infusion Site Haemorrhage
|
12.8%
5/39 • Number of events 6 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Fatigue
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Infusion Site Irritation
|
10.3%
4/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Infusion Site Swelling
|
10.3%
4/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Local swelling
|
7.7%
3/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Infections and infestations
Nasopharyngitis
|
15.4%
6/39 • Number of events 8 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Infections and infestations
Infusion Site Infection
|
10.3%
4/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.3%
4/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.3%
4/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
23.1%
9/39 • Number of events 9 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
17.9%
7/39 • Number of events 7 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
6/39 • Number of events 6 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
6/39 • Number of events 7 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Nervous system disorders
Headache
|
69.2%
27/39 • Number of events 28 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Nervous system disorders
Dizziness
|
17.9%
7/39 • Number of events 7 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.5%
8/39 • Number of events 8 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.3%
4/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Vascular disorders
Hypotension
|
7.7%
3/39 • Number of events 3 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Vascular disorders
Flushing
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Injection Site Inflammation
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
General disorders
Oedema
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Psychiatric disorders
Sleep disorder
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Nervous system disorders
Presyncope
|
5.1%
2/39 • Number of events 4 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
|
Infections and infestations
Infusion site abscess
|
5.1%
2/39 • Number of events 2 • Adverse events were recorded throughout the 16-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
|
Additional Information
Leigh Peterson, Director, Product Development, Product Development & Global Clinical Operations
United Therapeutics Corporation
Phone: 919-425-8165
Email: [email protected]
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