Trial Outcomes & Findings for Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension (NCT NCT02471183)

Last Updated: 2018-01-23

Results Overview

A sustained treatment transition is considered if the 3 following criteria are met a) being on study treatment (selexipag) at Week 16, and b) not having a study treatment interruption(s) of a total of 8 days or more prior to Week 16, and c) absence of inhaled treprostinil or any prostanoid treatment after Week 8 up to Week 16. The percentage of subjects with a sustained treatment transition is calculated with 95% confidence interval (CI) using the Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

At Week 16

Results posted on

2018-01-23

Participant Flow

Thirty-seven patients were screened. Among them, thirty-four patients with pulmonary arterial hypertension (PAH) and treated with inhaled treprostinil for at least 90 days were enrolled at 12 sites in the USA.

Participant milestones

Participant milestones
Measure	Selexipag The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Main Treatment Period STARTED	34
Main Treatment Period COMPLETED	32
Main Treatment Period NOT COMPLETED	2
Extended Treatment Period STARTED	32
Extended Treatment Period COMPLETED	31
Extended Treatment Period NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Selexipag The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Main Treatment Period Adverse Event	1
Main Treatment Period Withdrawal by Subject	1
Extended Treatment Period Lack of Efficacy	1

Baseline Characteristics

Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Age, Customized Age categories as per protocol · <= 65 years	28 Participants n=5 Participants
Age, Customized Age categories as per protocol · >65 years and <75 years	5 Participants n=5 Participants
Age, Customized Age categories as per protocol · >= 75 years	1 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Race categories as per protocol · Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Race categories as per protocol · Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Race categories as per protocol · White	28 Participants n=5 Participants
Race/Ethnicity, Customized Race categories as per protocol · Other	1 Participants n=5 Participants
Etiology of pulmonary arterial hypertension (PAH) Idiopathic	19 Participants n=5 Participants
Etiology of pulmonary arterial hypertension (PAH) Heritable	0 Participants n=5 Participants
Etiology of pulmonary arterial hypertension (PAH) Drug or toxin induced	5 Participants n=5 Participants
Etiology of pulmonary arterial hypertension (PAH) Associated PAH	10 Participants n=5 Participants
World Health Organization Functional class (WHO FC) FC I	0 Participants n=5 Participants
World Health Organization Functional class (WHO FC) FC II	25 Participants n=5 Participants
World Health Organization Functional class (WHO FC) FC III	9 Participants n=5 Participants
World Health Organization Functional class (WHO FC) FC IV	0 Participants n=5 Participants
Time since initial inhaled treprostinil	37.8 Months n=5 Participants
Treprostinil stable dose < 54 mcg q.i.d.	2 Participants n=5 Participants
Treprostinil stable dose 54 mcg q.i.d.	20 Participants n=5 Participants
Treprostinil stable dose > 54 mcg q.i.d.	12 Participants n=5 Participants
PAH-specific therapy at baseline PDE5-inhibitors alone	7 Participants n=5 Participants
PAH-specific therapy at baseline ERAs alone	4 Participants n=5 Participants
PAH-specific therapy at baseline ERAs and PDE-5	19 Participants n=5 Participants
PAH-specific therapy at baseline ERAs and sCG stimulator	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: All subjects who took at least one dose of selexipag were included in the safety analyses

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Percentage of Subjects With Sustained Treatment Transition	82.4 Percentage of participants Interval 65.5 to 93.2

PRIMARY outcome

Timeframe: 26 weeks on average (from the first dose of selexipag up to 30 days after the last dose of selexipag)

Population: All subjects who took at least one dose of selexipag were included in the safety analyses

Percentage of subjects with treatment-emergent AEs (serious and non serious), regardless of relationship to selexipag

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Percentage of Subjects With Treatment-emergent Adverse Events (AEs),	97.1 Percentage of participants

PRIMARY outcome

Timeframe: Up to 22 weeks on average

Population: All subjects who took at least one dose of selexipag were included in the safety analyses

Number of subjects with adverse events leading to premature discontinuation of selexipag is determined from the first dose of selexipag up to the last dose of selexipag

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Number of Subjects With Adverse Events Leading to Premature Discontinuation of Selexipag	3 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 16

Population: All subjects who took at least one dose of selexipag were included in the safety analyses

Both systolic(SBP) and diastolic (DBP) arterial blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points. Median change from baseline to pre-specified post-baseline visits are calculated

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Absolute Change From Baseline Over Time in Blood Pressure SBP change from baseline at week 12	-3.00 mmHg Interval -28.0 to 35.0
Absolute Change From Baseline Over Time in Blood Pressure SBP change from baseline at week 4	1.00 mmHg Interval -32.0 to 59.0
Absolute Change From Baseline Over Time in Blood Pressure SBP change from baseline at week 16	-4.00 mmHg Interval -24.0 to 25.0
Absolute Change From Baseline Over Time in Blood Pressure DBP change from baseline at week 4	-3.00 mmHg Interval -26.0 to 34.0
Absolute Change From Baseline Over Time in Blood Pressure DBP change from baseline at week 12	-4.00 mmHg Interval -30.0 to 48.0
Absolute Change From Baseline Over Time in Blood Pressure DBP change from baseline at week 16	-6.00 mmHg Interval -21.0 to 15.0

PRIMARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 16

Population: All subjects who took at least one dose of selexipag were included in the safety analyses

Pulse rate is measured after at least 5 minutes of rest in a sitting position. Median change from baseline to pre-specified post-baseline visits are calculated.

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Absolute Change From Baseline Over Time in Heart Rate (HR) HR change from baseline at week 4	4.00 beats per minute (bpm) Interval -23.0 to 22.0
Absolute Change From Baseline Over Time in Heart Rate (HR) HR change from baseline at week 12	6.00 beats per minute (bpm) Interval -34.0 to 33.0
Absolute Change From Baseline Over Time in Heart Rate (HR) HR change from baseline at week 16	3.00 beats per minute (bpm) Interval -35.0 to 23.0

PRIMARY outcome

Timeframe: At Week 12, in subjects still on selexipag at Week 16

Population: Sensitivity analysis: only patients being on selexipag at week 16 are considered.

This is the individual maximal tolerated dose (MTD) observed at Week 12 in the subjects still on selexipag at Week 16. MTD is defined as the dose of selexipag reached with the last dose change up to Week 12

Outcome measures

Outcome measures
Measure	Selexipag n=32 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Maximal Tolerated Dose	1200 mcg Interval 400.0 to 1600.0

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: All subjects who took at least one dose of selexipag were included in the safety analyses

Median time from baseline (Day1) to the end of down-titration of inhaled treprostinil is calculated

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Time to Discontinuation of Inhaled Treprostinil.	6.21 weeks Interval 1.0 to 14.9

SECONDARY outcome

Timeframe: Baseline and Week 16

The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension: Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class III (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms. Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined.

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Percentage of Subjects With WHO Functional Class (FC) Change From Baseline % subjects with WHO FC improvement	26.5 percentage of participants
Percentage of Subjects With WHO Functional Class (FC) Change From Baseline % subjects with WHO FC worsening	5.9 percentage of participants
Percentage of Subjects With WHO Functional Class (FC) Change From Baseline % subjects with WHO FC unchanged	67.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

The 6MWT is a non-encouraged test, which measures the distance (in meters) covered by the subject during a 6-minute walk. It is performed in a 30-meters long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Absolute change from baseline to Week 16 in 6MWD is measured at trough levels of inhaled treprostinil and/or selexipag. The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWT at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWT at Visit 5 (Week 16).

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Absolute Change in 6-minute Walk Distance (6MWD) at Trough	-10.25 meters Interval -25.6 to 8.8

SECONDARY outcome

Timeframe: Baseline and Week 16

Percentage of patients with an increase (\> 8% of baseline), maintenance (+/- 8% of baseline), or decrease (\< -8% of baseline) in their 6MWD (at trough) from baseline to Week 16. The ± 8% boundaries for change in 6MWD reflect the approximately 8% coefficient of variation in the reproducibility of the 6MWD. The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWD test at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWD test at Visit 5 (Week 16).

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Percentage of Patients With Change in 6-minute Walk Distance (6MWD) 6MWD decreased	26.5 Percentage of participants
Percentage of Patients With Change in 6-minute Walk Distance (6MWD) 6MWD maintained	55.9 Percentage of participants
Percentage of Patients With Change in 6-minute Walk Distance (6MWD) 6MWD increased	17.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Changes in NT-proBNP levels in plasma are expressed by the geometric mean of the ratio of Week 16 to baseline

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Geometric Mean of the Ratio in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) of Week 16 to Baseline	1.1 Geometric mean of the ratio Interval 0.82 to 1.62

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 16

The Treatment Satisfaction Questionnaire for Medication, Version II (TSQM II) is a validated tool that evaluate the subject's satisfaction with the study treatment. It includes a total of 11 questions related to satisfaction with treatment effectiveness, side effects,convenience, and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment.

Outcome measures

Outcome measures
Measure	Selexipag n=34 Participants The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Change From Baseline to Week 16 in the Treatment Satisfaction Questionnaire for Medication Questionnaire (TSQM II) Effectiveness (change from baseline)	0.00 Units on a scale Interval -8.3 to 8.3
Change From Baseline to Week 16 in the Treatment Satisfaction Questionnaire for Medication Questionnaire (TSQM II) Side effects (change from baseline)	0.00 Units on a scale Interval -16.7 to 0.0
Change From Baseline to Week 16 in the Treatment Satisfaction Questionnaire for Medication Questionnaire (TSQM II) Convenience (change from baseline)	44.44 Units on a scale Interval 27.8 to 61.1
Change From Baseline to Week 16 in the Treatment Satisfaction Questionnaire for Medication Questionnaire (TSQM II) Global satisfaction (change from baseline)	8.33 Units on a scale Interval 0.0 to 25.0

Adverse Events

Selexipag

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Selexipag n=34 participants at risk All subjects who take at least one dose of selexipag. The mean duration of exposure to selexipag was 21.6 weeks
Nervous system disorders Generalised tonic-clonic seizure	2.9% 1/34 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation
Musculoskeletal and connective tissue disorders Muscle haemorrhage	2.9% 1/34 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Nausea	2.9% 1/34 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation
Nervous system disorders Syncope	2.9% 1/34 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Vomiting	2.9% 1/34 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation

Other adverse events

Other adverse events
Measure	Selexipag n=34 participants at risk All subjects who take at least one dose of selexipag. The mean duration of exposure to selexipag was 21.6 weeks
Gastrointestinal disorders Abdominal discomfort	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Abdominal distension	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Abdominal pain	14.7% 5/34 • Number of events 5 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Abdominal pain upper	8.8% 3/34 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 4/34 • Number of events 6 • From study treatment initiation up to 30 days after study treatment discontinuation
Investigations Brain natriuretic peptide increased	8.8% 3/34 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation
General disorders Chest pain	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
General disorders Chills	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Respiratory, thoracic and mediastinal disorders Cough	8.8% 3/34 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation
Metabolism and nutrition disorders Decreased appetite	11.8% 4/34 • Number of events 4 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Diarrhoea	70.6% 24/34 • Number of events 32 • From study treatment initiation up to 30 days after study treatment discontinuation
Nervous system disorders Dizziness	20.6% 7/34 • Number of events 10 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Dyspepsia	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Respiratory, thoracic and mediastinal disorders Dyspnoea	32.4% 11/34 • Number of events 14 • From study treatment initiation up to 30 days after study treatment discontinuation
General disorders Fatigue	23.5% 8/34 • Number of events 10 • From study treatment initiation up to 30 days after study treatment discontinuation
Vascular disorders Flushing	23.5% 8/34 • Number of events 11 • From study treatment initiation up to 30 days after study treatment discontinuation
Nervous system disorders Headache	79.4% 27/34 • Number of events 40 • From study treatment initiation up to 30 days after study treatment discontinuation
Skin and subcutaneous tissue disorders Hyperhidrosis	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Vascular disorders Hypotension	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Musculoskeletal and connective tissue disorders Myalgia	26.5% 9/34 • Number of events 11 • From study treatment initiation up to 30 days after study treatment discontinuation
Investigations N-terminal prohormone brain natriuretic peptide increased	11.8% 4/34 • Number of events 4 • From study treatment initiation up to 30 days after study treatment discontinuation
Infections and infestations Nasopharyngitis	8.8% 3/34 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation
Gastrointestinal disorders Nausea	20.6% 7/34 • Number of events 7 • From study treatment initiation up to 30 days after study treatment discontinuation
General disorders Oedema peripheral	14.7% 5/34 • Number of events 6 • From study treatment initiation up to 30 days after study treatment discontinuation
General disorders Pain	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Musculoskeletal and connective tissue disorders Pain in extremity	20.6% 7/34 • Number of events 8 • From study treatment initiation up to 30 days after study treatment discontinuation
Musculoskeletal and connective tissue disorders Pain in jaw	47.1% 16/34 • Number of events 18 • From study treatment initiation up to 30 days after study treatment discontinuation
Nervous system disorders Paraesthesia	8.8% 3/34 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation
Renal and urinary disorders Pollakiuria	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Nervous system disorders Presyncope	8.8% 3/34 • Number of events 4 • From study treatment initiation up to 30 days after study treatment discontinuation
General disorders Pyrexia	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Nervous system disorders Syncope	5.9% 2/34 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation
Infections and infestations Upper respiratory tract infection	8.8% 3/34 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation

Additional Information

Global Post approval studies Director

Actelion Pharmaceuticals Ltd

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation. Upon review, Actelion may provide comments, and may also request changes for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.
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