Trial Outcomes & Findings for A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study (NCT NCT04565990)
NCT ID: NCT04565990
Last Updated: 2025-05-01
Results Overview
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days. Data includes all TEAEs irrespective of whether they were serious or non-serious.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Results posted on
2025-05-01
Participant Flow
Participant milestones
| Measure |
Selexipag
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Selexipag
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study
Baseline characteristics by cohort
| Measure |
Selexipag
n=43 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
37 Participants
n=5 Participants
|
|
Age, Customized
From 65 to 84 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
>=85 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
BELARUS
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
INDIA
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
ROMANIA
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
TAIWAN
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
UKRAINE
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention in this study..
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days. Data includes all TEAEs irrespective of whether they were serious or non-serious.
Outcome measures
| Measure |
Selexipag
n=43 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
22 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention in this study.
Number of participants with TEAEs leading to premature discontinuation of selexipag were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days.
Outcome measures
| Measure |
Selexipag
n=43 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Number of Participants With TEAEs Leading to Premature Discontinuation of Selexipag
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention in this study.
Number of participants with TESAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TESAEs were defined as TSAEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days.
Outcome measures
| Measure |
Selexipag
n=43 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
|
7 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention in this study.
Number of participants with treatment-emergent deaths during the study were reported.
Outcome measures
| Measure |
Selexipag
n=43 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Number of Participants With Treatment-emergent Deaths
|
5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 30 days after last dose of drug (up to 29 months)Population: Safety analysis set included all participants who received at least 1 dose of study intervention in this study. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Number of pregnant females with maternal exposure to selexipag were reported.
Outcome measures
| Measure |
Selexipag
n=36 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Number of Pregnant Females With Maternal Exposure to Selexipag
|
0 Participants
|
Adverse Events
Selexipag
Serious events: 7 serious events
Other events: 20 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Selexipag
n=43 participants at risk
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Cardiac disorders
Cardiac Failure Acute
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Covid-19 Pneumonia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Subacute Endocarditis
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Syphilis
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Musculoskeletal and connective tissue disorders
Systemic Scleroderma
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
|
7.0%
3/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
Other adverse events
| Measure |
Selexipag
n=43 participants at risk
Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms \[mcg\] selexipag tablet orally twice daily \[bid\]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Cardiac disorders
Pericardial Effusion
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Endocrine disorders
Goitre
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Gastrointestinal disorders
Chronic Gastritis
|
4.7%
2/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Gastrointestinal disorders
Gastric Mucosa Erythema
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
General disorders
Pain
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
General disorders
Pyrexia
|
4.7%
2/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Hepatobiliary disorders
Non-Alcoholic Fatty Liver
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Hepatobiliary disorders
Steatohepatitis
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Influenza
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Otitis Media Acute
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Respiratory Tract Infection
|
4.7%
2/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Urinary Tract Infection
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Infections and infestations
Covid-19
|
9.3%
4/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Investigations
Complement Factor C3 Decreased
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Investigations
Complement Factor C4 Decreased
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Investigations
Double Stranded Dna Antibody Positive
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Biliary Neoplasm
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of Liver
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
|
Vascular disorders
Hypertension
|
2.3%
1/43 • All cause mortality: From Day 1 up to 30 days after last dose of drug (up to 29 months), Other AEs and SAEs: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention in this study.
|
Additional Information
Executive Medical Director CP
Actelion Pharmaceuticals Ltd
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER