Trial Outcomes & Findings for ACT-293987 in Pulmonary Arterial Hypertension (NCT NCT01112306)
NCT ID: NCT01112306
Last Updated: 2025-03-30
Results Overview
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
709 participants
Primary outcome timeframe
Up to 3 days after study drug discontinuation (Up to 10.5 years)
Results posted on
2025-03-30
Participant Flow
Survival analysis was planned in subset of participants who received selexipag in main study (NCT01106014) and either entered or did not enter this open label (OL) study. Safety analysis including all-cause mortality was planned for OL safety set. Hence, all-cause mortality data is based on participants who received study drug (selexipag or placebo) in main study and entered this OL study. Participants who did not enter this OL study were not analyzed for all-cause mortality.
Participant milestones
| Measure |
Selexipag
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Overall Study
STARTED
|
709
|
|
Overall Study
COMPLETED
|
424
|
|
Overall Study
NOT COMPLETED
|
285
|
Reasons for withdrawal
| Measure |
Selexipag
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Overall Study
Death
|
175
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Withdrawal by Subject
|
31
|
|
Overall Study
Other
|
70
|
Baseline Characteristics
ACT-293987 in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Selexipag
n=709 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 15.19 • n=93 Participants
|
|
Sex: Female, Male
Female
|
590 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
171 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
15 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
HISPANIC
|
87 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
8 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
428 Participants
n=93 Participants
|
|
Region of Enrollment
ARGENTINA
|
20 Participants
n=93 Participants
|
|
Region of Enrollment
AUSTRALIA
|
37 Participants
n=93 Participants
|
|
Region of Enrollment
AUSTRIA
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
BELARUS
|
34 Participants
n=93 Participants
|
|
Region of Enrollment
BELGIUM
|
17 Participants
n=93 Participants
|
|
Region of Enrollment
CANADA
|
13 Participants
n=93 Participants
|
|
Region of Enrollment
CHILE
|
31 Participants
n=93 Participants
|
|
Region of Enrollment
CHINA
|
113 Participants
n=93 Participants
|
|
Region of Enrollment
COLOMBIA
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
11 Participants
n=93 Participants
|
|
Region of Enrollment
DENMARK
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
FRANCE
|
21 Participants
n=93 Participants
|
|
Region of Enrollment
GERMANY
|
35 Participants
n=93 Participants
|
|
Region of Enrollment
GREECE
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
HUNGARY
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
INDIA
|
15 Participants
n=93 Participants
|
|
Region of Enrollment
IRELAND
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
ISRAEL
|
11 Participants
n=93 Participants
|
|
Region of Enrollment
ITALY
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
MALAYSIA
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
MEXICO
|
20 Participants
n=93 Participants
|
|
Region of Enrollment
NETHERLANDS
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
PERU
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
POLAND
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
ROMANIA
|
9 Participants
n=93 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
72 Participants
n=93 Participants
|
|
Region of Enrollment
SERBIA
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
SINGAPORE
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
SLOVAKIA
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
11 Participants
n=93 Participants
|
|
Region of Enrollment
SPAIN
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
SWEDEN
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
SWITZERLAND
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
TAIWAN
|
11 Participants
n=93 Participants
|
|
Region of Enrollment
THAILAND
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
TURKEY
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
UKRAINE
|
35 Participants
n=93 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
9 Participants
n=93 Participants
|
|
Region of Enrollment
UNITED STATES
|
80 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 3 days after study drug discontinuation (Up to 10.5 years)Population: The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
Outcome measures
| Measure |
Selexipag
n=709 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation
|
684 Participants
|
PRIMARY outcome
Timeframe: Up to 3 days after study drug discontinuation (Up to 10.5 years)Population: The OL safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.
Outcome measures
| Measure |
Selexipag
n=709 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation
|
420 Participants
|
PRIMARY outcome
Timeframe: Up to 10.5 yearsPopulation: The OL safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
Outcome measures
| Measure |
Selexipag
n=709 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention
|
129 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120Population: Selexipag-treated set (STS): all participants who received at least 1 dose of selexipag in either main study (NCT01106014) or this OL study (NCT01112306). Survival analysis was planned in a subset of STS participants who received selexipag in main study, entered or did not enter this OL study. Here, "n" (number analyzed): participants at risk (alive and on study), analyzed at each specified timepoint.
Percentage of alive participants were analyzed using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Selexipag
n=574 Participants
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Percentage of Alive Participants
KM estimate at Baseline (Day 1)
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Alive Participants
KM estimate at Month 3
|
98.4 Percentage of participants
Interval 97.0 to 99.2
|
|
Percentage of Alive Participants
KM estimate at Month 6
|
96.3 Percentage of participants
Interval 94.4 to 97.6
|
|
Percentage of Alive Participants
KM estimate at Month 9
|
94.0 Percentage of participants
Interval 91.7 to 95.7
|
|
Percentage of Alive Participants
KM estimate at Month 12
|
92.0 Percentage of participants
Interval 89.4 to 94.0
|
|
Percentage of Alive Participants
KM estimate at Month 24
|
85.3 Percentage of participants
Interval 82.0 to 88.0
|
|
Percentage of Alive Participants
KM estimate at Month 36
|
79.3 Percentage of participants
Interval 75.4 to 82.6
|
|
Percentage of Alive Participants
KM estimate at Month 48
|
75.2 Percentage of participants
Interval 70.9 to 78.9
|
|
Percentage of Alive Participants
KM estimate at Month 60
|
71.2 Percentage of participants
Interval 66.5 to 75.3
|
|
Percentage of Alive Participants
KM estimate at Month 72
|
66.8 Percentage of participants
Interval 61.6 to 71.4
|
|
Percentage of Alive Participants
KM estimate at Month 84
|
63.3 Percentage of participants
Interval 57.8 to 68.3
|
|
Percentage of Alive Participants
KM estimate at Month 96
|
60.3 Percentage of participants
Interval 54.4 to 65.7
|
|
Percentage of Alive Participants
KM estimate at Month 108
|
56.9 Percentage of participants
Interval 50.3 to 62.9
|
|
Percentage of Alive Participants
KM estimate at Month 120
|
56.9 Percentage of participants
Interval 50.3 to 62.9
|
Adverse Events
Selexipag
Serious events: 420 serious events
Other events: 598 other events
Deaths: 186 deaths
Serious adverse events
| Measure |
Selexipag
n=709 participants at risk
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Infections and infestations
Pyelonephritis Acute
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Pyoderma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Rhinitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Sepsis
|
1.4%
10/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Septic Shock
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
9/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Anaemia Vitamin B12 Deficiency
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Immune Thrombocytopenic Purpura
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Lymphadenopathy Mediastinal
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Pseudolymphoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Acute Right Ventricular Failure
|
1.6%
11/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Angina Pectoris
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Arrhythmia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.4%
17/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Atrial Flutter
|
1.1%
8/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Atrial Tachycardia
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Atrioventricular Block
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiac Arrest
|
1.8%
13/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiac Failure
|
1.1%
8/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.71%
5/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiogenic Shock
|
1.3%
9/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
1.1%
8/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiorenal Syndrome
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Chronic Left Ventricular Failure
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Chronic Right Ventricular Failure
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cor Pulmonale
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Cor Pulmonale Acute
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Left Ventricular Failure
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Myocardial Infarction
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Pericardial Effusion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Right Ventricular Failure
|
13.1%
93/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Ventricular Tachyarrhythmia
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Congenital, familial and genetic disorders
Dermoid Cyst
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Congenital, familial and genetic disorders
Haemorrhagic Arteriovenous Malformation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Endocrine disorders
Adrenocortical Insufficiency Acute
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Endocrine disorders
Basedow's Disease
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Endocrine disorders
Hyperthyroidism
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Endocrine disorders
Thyroiditis Subacute
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Eye disorders
Astigmatism
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Eye disorders
Diabetic Retinopathy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Eye disorders
Glaucoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Ascites
|
0.85%
6/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Colitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
12/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.3%
9/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Haematemesis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Melaena
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Obstructive Pancreatitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Oesophageal Haemorrhage
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Catheter Site Erythema
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Catheter Site Thrombosis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Chest Discomfort
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Chest Pain
|
0.99%
7/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Death
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Drowning
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Drug Ineffective
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Drug Interaction
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Euthanasia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Fatigue
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Gait Disturbance
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Generalised Oedema
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
1.1%
8/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Oedema Peripheral
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Organ Failure
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Peripheral Swelling
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Pyrexia
|
0.71%
5/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Sudden Cardiac Death
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Sudden Death
|
2.0%
14/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Withdrawal Syndrome
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Cardiac Cirrhosis
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Cirrhosis Alcoholic
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Hepatobiliary disorders
Jaundice
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Immune system disorders
Amyloidosis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Abscess Bacterial
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Abscess Limb
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Actinomycotic Pulmonary Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Anal Abscess
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Appendicitis
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Appendicitis Perforated
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Atypical Pneumonia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Bacterial Abdominal Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Bacterial Sepsis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Bronchitis
|
1.6%
11/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Cellulitis
|
0.85%
6/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Colonic Abscess
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Complicated Appendicitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Corona Virus Infection
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Cystitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Dengue Fever
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Disseminated Tuberculosis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Empyema
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Endocarditis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Enterobacter Sepsis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Erysipelas
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Escherichia Sepsis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Gastroenteritis Clostridial
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Gastroenteritis Norovirus
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
H1n1 Influenza
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Haematoma Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Haemorrhagic Pneumonia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Herpes Zoster
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Infection
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Infective Tenosynovitis
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Influenza
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.1%
8/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Lung Infection
|
0.71%
5/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Osteomyelitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Otitis Media Bacterial
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Peritonitis
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Peritonitis Bacterial
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Pneumonia
|
7.1%
50/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Pneumonia Viral
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Pyelonephritis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Sialoadenitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Soft Tissue Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Tracheobronchitis
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Urinary Tract Infection
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Viral Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Wound Infection
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Accident
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Anaesthetic Complication
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
8/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Fractured Sacrum
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Reactive Gastropathy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Anticoagulation Drug Level above Therapeutic
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Biopsy Kidney
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Blood Uric Acid Increased
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Catheterisation Cardiac
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Haemoglobin Decreased
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
International Normalised Ratio Increased
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Investigation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
N-Terminal Prohormone Brain Natriuretic Peptide Increased
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Precancerous Cells Present
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Prothrombin Time Prolonged
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Transplant Evaluation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Investigations
Weight Decreased
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Fracture Malunion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Haematoma Muscle
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Mixed Connective Tissue Disease
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Still's Disease
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Systemic Scleroderma
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Salivary Gland Neoplasm
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Recurrent
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour of the Stomach
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Adenocarcinoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer Stage I
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to the Mediastinum
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodal Marginal Zone B-Cell Lymphoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Germ Cell Teratoma Benign
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Carotid Artery Occlusion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Cerebral Infarction
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Headache
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Intracranial Haematoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Presyncope
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Seizure
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Syncope
|
2.5%
18/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Missed
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.71%
5/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Psychiatric disorders
Acute Psychosis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Psychiatric disorders
Anxiety
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Psychiatric disorders
Drug Dependence
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Psychiatric disorders
Major Depression
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Psychiatric disorders
Suicide Attempt
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.85%
6/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Glomerulonephritis Chronic
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Haematuria
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Ischaemic Nephropathy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Lupus Nephritis
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Proteinuria
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Renal Failure
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Renal Haematoma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Renal Impairment
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Tubulointerstitial Nephritis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Renal and urinary disorders
Urinary Retention
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.71%
5/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
18/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
10/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity Pneumonitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Inflammation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus Pneumonitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Alveolar Haemorrhage
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
|
23.8%
169/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Artery Aneurysm
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Artery Dilatation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.1%
8/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.56%
4/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Balloon Atrial Septostomy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Benign Breast Lump Removal
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Breast Conserving Surgery
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Coronary Angioplasty
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Coronary Arterial Stent Insertion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Drug Therapy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Fasciotomy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Gastric Bypass
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Heart and Lung Transplant
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Knee Operation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Lung Transplant
|
0.71%
5/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Nephrectomy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Ovarian Cystectomy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Packed Red Blood Cell Transfusion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Rehabilitation Therapy
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Transfusion
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Varicose Vein Operation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Surgical and medical procedures
Vascular Operation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Circulatory Collapse
|
0.28%
2/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.42%
3/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Hypotension
|
0.85%
6/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Superior Vena Cava Perforation
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Vasculitis
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.14%
1/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
Other adverse events
| Measure |
Selexipag
n=709 participants at risk
Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms \[mcg\], twice daily \[bid\] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.2%
65/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Cardiac disorders
Palpitations
|
6.1%
43/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.5%
209/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
135/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
74/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Fatigue
|
6.2%
44/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
General disorders
Oedema Peripheral
|
12.7%
90/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Bronchitis
|
8.3%
59/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
12.4%
88/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.8%
84/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
42/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
44/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.2%
65/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.6%
68/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.0%
78/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
18.3%
130/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Dizziness
|
10.0%
71/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Nervous system disorders
Headache
|
46.3%
328/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
80/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.7%
76/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
|
9.6%
68/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Flushing
|
6.9%
49/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
|
Vascular disorders
Hypotension
|
5.4%
38/709 • Up to 10.5 years
The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.
|
Additional Information
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