Trial Outcomes & Findings for Rapid Switch From Flolan to Remodulin in the Outpatient Clinic (NCT NCT00643604)

NCT ID: NCT00643604

Last Updated: 2024-01-03

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: Baseline and Week 8
• Results posted on: 2024-01-03

Participant Flow

The first subject was enrolled in March 2008. Given the limited availability of eligible subjects at the investigative center (stable PH patients on stable epoprostenol therapy) and competition for enrollment by other studies, after an extended recruitment period during which no new subjects were enrolled, the study was subsequently closed.

Participant milestones

Measure	Treprostinil Sodium treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treprostinil Sodium treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Study Death	1

Baseline Characteristics

Rapid Switch From Flolan to Remodulin in the Outpatient Clinic

Baseline characteristics by cohort

Measure	Treprostinil Sodium n=7 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.6 years FULL_RANGE 32-58 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Pulmonary Arterial Hypertension (PAH) etiology Idiopathic PAH	5 participants n=5 Participants
Pulmonary Arterial Hypertension (PAH) etiology Collagen Vascular Disease	1 participants n=5 Participants
Pulmonary Arterial Hypertension (PAH) etiology Portal Hypertension	1 participants n=5 Participants
World Health Organization (WHO) functional Class at time of transition Class II	5 participants n=5 Participants
World Health Organization (WHO) functional Class at time of transition Class III	2 participants n=5 Participants
Baseline 6 Minute Walk Distance (6MWD)	466.6 meters n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Six Minute Walk Distance	-14 meter Standard Deviation 63.7

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.

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	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in WHO Functional Classification Improved	0 participants
Change in WHO Functional Classification No change	5 participants
Change in WHO Functional Classification Worsened	1 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.

The Borg Dyspnea Score is a 10-point scale rating the maximum level of dyspnea experienced after the Six-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Borg Dyspnea Score Immediately After Six Minute Walk	0.67 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Two subjects with a Week 8 visit outside of the visit window are included in the summary. One subject died prior to completing the Week 8 visit. One subject had an incomplete Baseline questionnaire and the CAMPHOR Activity component could not be calculated, therefore N=5 Activity and Total Score Components, and N=6 for Symptom and Quality of Life.

The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning 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, lower scores indicate improvements.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Activitity Score	-0.8 units on a scale Standard Deviation 2.6
Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Symptom Score	-2.5 units on a scale Standard Deviation 2.0
Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life Score	-4.4 units on a scale Standard Deviation 6.7
Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Total Score	-8.0 units on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.

The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua(e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Score on Treatment Satisfaction Questionnaire for Medication Effectiveness Score	-9.3 units on a scale Standard Deviation 13.0
Change in Score on Treatment Satisfaction Questionnaire for Medication Side-Effects Score	19.8 units on a scale Standard Deviation 28.9
Change in Score on Treatment Satisfaction Questionnaire for Medication Convenience Score	22.2 units on a scale Standard Deviation 12.2
Change in Score on Treatment Satisfaction Questionnaire for Medication Global Satisfaction Score	-1.2 units on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Two subjects did not have Week 8 Drug Administration Activity Diaries completed. Connect Drug and Total Time Components: N=4; One subject did not have data recorded for Connect drug activities. Total time could not be calculated for this subject.

A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin. Drug Administration Activities Diary results are reported as average time per week spent on drug administration activities

Outcome measures

Measure	Treprostinil Sodium n=5 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol Gather/Set-up	-2.6 minutes Standard Deviation 4.0
Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol Prepare Drug	-39.4 minutes Standard Deviation 12.8
Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol Connect Drug	-5.0 minutes Standard Deviation 11.3
Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol Change Dressing	0.0 minutes Standard Deviation 10.6
Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol Total Time	-44.0 minutes Standard Deviation 25.2

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.

The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in PAH Signs and Symptoms- Fatigue Improved	0 participants
Change in PAH Signs and Symptoms- Fatigue No Change	4 participants
Change in PAH Signs and Symptoms- Fatigue Worsened	2 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change From in Signs and Symptoms of PAH- Edema Improved	0 participants
Change From in Signs and Symptoms of PAH- Edema No Change	3 participants
Change From in Signs and Symptoms of PAH- Edema Worsened	3 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Signs and Symptoms of PAH- Dyspnea Improved	1 participants
Change in Signs and Symptoms of PAH- Dyspnea No Change	3 participants
Change in Signs and Symptoms of PAH- Dyspnea Worsened	2 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Signs and Symptoms of PAH- Orthopnea No Change	4 participants
Change in Signs and Symptoms of PAH- Orthopnea Improved	0 participants
Change in Signs and Symptoms of PAH- Orthopnea Worsened	2 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Signs and Symptoms of PAH- Dizziness Improved	0 participants
Change in Signs and Symptoms of PAH- Dizziness No Change	5 participants
Change in Signs and Symptoms of PAH- Dizziness Worsened	1 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Signs and Symptoms of PAH- Syncope Improved	0 participants
Change in Signs and Symptoms of PAH- Syncope No Change	6 participants
Change in Signs and Symptoms of PAH- Syncope Worsened	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Change in Signs and Symptoms of PAH- Chest Pain Improved	0 participants
Change in Signs and Symptoms of PAH- Chest Pain No Change	5 participants
Change in Signs and Symptoms of PAH- Chest Pain Worsened	1 participants

SECONDARY outcome

Timeframe: Week 8

Population: Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.

A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.

Outcome measures

Measure	Treprostinil Sodium n=6 Participants treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Patient Impression of Change Questionnaire Symptoms- Much Better	0 participants
Patient Impression of Change Questionnaire Symptoms-Somewhat Better	2 participants
Patient Impression of Change Questionnaire Symptoms- About the Same	3 participants
Patient Impression of Change Questionnaire Symptoms- Somewhat Worse	1 participants
Patient Impression of Change Questionnaire Symptoms-Much Worse	0 participants
Patient Impression of Change Questionnaire Time Spent- Much Less	3 participants
Patient Impression of Change Questionnaire Time Spent- Somewhat Less	3 participants
Patient Impression of Change Questionnaire Time Spent- About the Same	0 participants
Patient Impression of Change Questionnaire Time Spent- Somewhat More	0 participants
Patient Impression of Change Questionnaire Time Spent- Much More	0 participants
Patient Impression of Change Questionnaire Satisfaction- Much More Satisfied	1 participants
Patient Impression of Change Questionnaire Satisfaction- More Satisfied	3 participants
Patient Impression of Change Questionnaire Satisfaction- About the Same	1 participants
Patient Impression of Change Questionnaire Satisfaction- Less Satisfied	1 participants
Patient Impression of Change Questionnaire Satisfaction- Much Less Satisfied	0 participants

Adverse Events

Treprostinil Sodium

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treprostinil Sodium n=7 participants at risk treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Infections and infestations Bacteraemia	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Metabolism and nutrition disorders Dehydration	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.

Other adverse events

Measure	Treprostinil Sodium n=7 participants at risk treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Nervous system disorders Headache	71.4% 5/7 • Number of events 6 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Gastrointestinal disorders Nausea	42.9% 3/7 • Number of events 3 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 3 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Gastrointestinal disorders Diarrhoea	42.9% 3/7 • Number of events 4 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Musculoskeletal and connective tissue disorders Pain in Extremity	42.9% 3/7 • Number of events 3 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Psychiatric disorders Anxiety	28.6% 2/7 • Number of events 2 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Psychiatric disorders Insomnia	28.6% 2/7 • Number of events 2 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Musculoskeletal and connective tissue disorders Back Pain	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Vascular disorders Flushing	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Musculoskeletal and connective tissue disorders Pain in Jaw	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
General disorders Pyrexia	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Nervous system disorders Sinus headache	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Nervous system disorders Tremor	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
General disorders Infusion site reaction	14.3% 1/7 • Number of events 1 • Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8) Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.

Additional Information

Remodulin Program Leader

United Therapeutics Corporation

Phone: 919-485-8350

Email: clinicalrecordsmanagement@unither.com

Results disclosure agreements

• Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the Principal Investigator's rights to discuss or publish trial results after the trial is completed. Any publication of the results of this trial must be consistent with the United Therapeutics publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the Investigator contract.
• Publication restrictions are in place

Restriction type: OTHER