Trial Outcomes & Findings for A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment (NCT NCT03689244)
NCT ID: NCT03689244
Last Updated: 2024-06-21
Results Overview
Change from baseline in PVR at Week 20 was reported. PVR was measured by accessing the vessel either from right heart catheterization or left heart catheterization, if required. Change from baseline in PVR was measured as percent ratio of post treatment value (Week 20) to pre-treatment value (baseline).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
128 participants
Primary outcome timeframe
Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20
Results posted on
2024-06-21
Participant Flow
A total of 321 participants were screened, of which 128 were randomly assigned and received study intervention.
Participant milestones
| Measure |
Double-blind Period: Placebo
Participants received a single oral tablet of placebo matching to selexipag 200 micrograms (mcg) in the evening of Day 1 and continued the same dose (200 mcg) twice daily (BID) on Day 2. Upon first dose toleration, placebo dose was up-titrated with weekly increments of 200 mcg until reaching the individual maximum tolerated dose (iMTD) in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of DB treatment (EDBT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 24.6 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate Cytochrome P-450 2C8 (CYP2C8) inhibitor, the dosing frequency was to be once daily (QD).
|
Double-blind Period: Selexipag
Participants received a single oral tablet of selexipag 200 mcg in the evening of Day 1 and continued the same dose (200 mcg) BID on Day 2. Upon first dose toleration, selexipag dose was up-titrated with weekly increments of 200 mcg until reaching the iMTD in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EDBT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 27.7 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate CYP2C8 inhibitor, the dosing frequency was to be QD.
|
Open Label Period: Selexipag (Ex-Placebo)
All participants (received placebo in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of OL treatment (EOLT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 20.8 months).
|
Open Label Period: Selexipag (Ex-Selexipag)
All participants (received selexipag in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EOLT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 19.8 months).
|
|---|---|---|---|---|
|
Double Blind Period (Up to 27.7 Months)
STARTED
|
64
|
64
|
0
|
0
|
|
Double Blind Period (Up to 27.7 Months)
COMPLETED
|
9
|
6
|
0
|
0
|
|
Double Blind Period (Up to 27.7 Months)
NOT COMPLETED
|
55
|
58
|
0
|
0
|
|
Open Label Period (Up to 20.8 Months)
STARTED
|
0
|
0
|
9
|
6
|
|
Open Label Period (Up to 20.8 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open Label Period (Up to 20.8 Months)
NOT COMPLETED
|
0
|
0
|
9
|
6
|
Reasons for withdrawal
| Measure |
Double-blind Period: Placebo
Participants received a single oral tablet of placebo matching to selexipag 200 micrograms (mcg) in the evening of Day 1 and continued the same dose (200 mcg) twice daily (BID) on Day 2. Upon first dose toleration, placebo dose was up-titrated with weekly increments of 200 mcg until reaching the individual maximum tolerated dose (iMTD) in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of DB treatment (EDBT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 24.6 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate Cytochrome P-450 2C8 (CYP2C8) inhibitor, the dosing frequency was to be once daily (QD).
|
Double-blind Period: Selexipag
Participants received a single oral tablet of selexipag 200 mcg in the evening of Day 1 and continued the same dose (200 mcg) BID on Day 2. Upon first dose toleration, selexipag dose was up-titrated with weekly increments of 200 mcg until reaching the iMTD in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EDBT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 27.7 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate CYP2C8 inhibitor, the dosing frequency was to be QD.
|
Open Label Period: Selexipag (Ex-Placebo)
All participants (received placebo in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of OL treatment (EOLT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 20.8 months).
|
Open Label Period: Selexipag (Ex-Selexipag)
All participants (received selexipag in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EOLT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 19.8 months).
|
|---|---|---|---|---|
|
Double Blind Period (Up to 27.7 Months)
Withdrawal by Subject
|
7
|
8
|
0
|
0
|
|
Double Blind Period (Up to 27.7 Months)
Other
|
1
|
1
|
0
|
0
|
|
Double Blind Period (Up to 27.7 Months)
Sponsor decision
|
44
|
47
|
0
|
0
|
|
Double Blind Period (Up to 27.7 Months)
Death
|
1
|
0
|
0
|
0
|
|
Double Blind Period (Up to 27.7 Months)
Physician Decision
|
2
|
2
|
0
|
0
|
|
Open Label Period (Up to 20.8 Months)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Open Label Period (Up to 20.8 Months)
Physician Decision
|
0
|
0
|
1
|
0
|
|
Open Label Period (Up to 20.8 Months)
Sponsor Decision
|
0
|
0
|
7
|
6
|
Baseline Characteristics
A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment
Baseline characteristics by cohort
| Measure |
Double-blind Period: Placebo
n=64 Participants
Participants received a single oral tablet of placebo matching to selexipag 200 micrograms (mcg) in the evening of Day 1 and continued the same dose (200 mcg) twice daily (BID) on Day 2. Upon first dose toleration, placebo dose was up-titrated with weekly increments of 200 mcg until reaching the individual maximum tolerated dose (iMTD) in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of DB treatment (EDBT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 24.6 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate Cytochrome P-450 2C8 (CYP2C8) inhibitor, the dosing frequency was to be once daily (QD).
|
Double-blind Period: Selexipag
n=64 Participants
Participants received a single oral tablet of selexipag 200 mcg in the evening of Day 1 and continued the same dose (200 mcg) BID on Day 2. Upon first dose toleration, selexipag dose was up-titrated with weekly increments of 200 mcg until reaching the iMTD in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EDBT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 27.7 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate CYP2C8 inhibitor, the dosing frequency was to be QD.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 13.22 • n=5 Participants
|
62 years
STANDARD_DEVIATION 14.38 • n=7 Participants
|
63 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
ARGENTINA
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
AUSTRALIA
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
BELGIUM
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
BRAZIL
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
BULGARIA
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
CANADA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
CHINA
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
DENMARK
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
GERMANY
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
HUNGARY
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
ISRAEL
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
ITALY
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
MEXICO
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
PORTUGAL
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
SLOVAKIA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
SPAIN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
SWEDEN
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
TAIWAN
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
THAILAND
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
TURKEY
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
UKRAINE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20Population: Hemodynamic set (HES) included all assigned participants in the hemodynamic cohort.
Change from baseline in PVR at Week 20 was reported. PVR was measured by accessing the vessel either from right heart catheterization or left heart catheterization, if required. Change from baseline in PVR was measured as percent ratio of post treatment value (Week 20) to pre-treatment value (baseline).
Outcome measures
| Measure |
Double-blind Period: Placebo
n=44 Participants
Participants received a single oral tablet of placebo matching to selexipag 200 micrograms (mcg) in the evening of Day 1 and continued the same dose (200 mcg) twice daily (BID) on Day 2. Upon first dose toleration, placebo dose was up-titrated with weekly increments of 200 mcg until reaching the individual maximum tolerated dose (iMTD) in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of DB treatment (EDBT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 24.6 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate Cytochrome P-450 2C8 (CYP2C8) inhibitor, the dosing frequency was to be once daily (QD).
|
Double-blind Period: Selexipag
n=47 Participants
Participants received a single oral tablet of selexipag 200 mcg in the evening of Day 1 and continued the same dose (200 mcg) BID on Day 2. Upon first dose toleration, selexipag dose was up-titrated with weekly increments of 200 mcg until reaching the iMTD in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EDBT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 27.7 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate CYP2C8 inhibitor, the dosing frequency was to be QD.
|
|---|---|---|
|
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20
|
89.52 Percent ratio
Interval 81.78 to 97.99
|
85.15 Percent ratio
Interval 77.97 to 92.99
|
Adverse Events
Double-blind Period: Placebo
Serious events: 16 serious events
Other events: 45 other events
Deaths: 2 deaths
Double-blind Period: Selexipag
Serious events: 9 serious events
Other events: 60 other events
Deaths: 3 deaths
Open Label Period: Selexipag (Ex-Placebo)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Open Label Period: Selexipag (Ex-Selexipag)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind Period: Placebo
n=64 participants at risk
Participants received a single oral tablet of placebo matching to selexipag 200 micrograms (mcg) in the evening of Day 1 and continued the same dose (200 mcg) twice daily (BID) on Day 2. Upon first dose toleration, placebo dose was up-titrated with weekly increments of 200 mcg until reaching the individual maximum tolerated dose (iMTD) in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of DB treatment (EDBT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 24.6 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate Cytochrome P-450 2C8 (CYP2C8) inhibitor, the dosing frequency was to be once daily (QD).
|
Double-blind Period: Selexipag
n=64 participants at risk
Participants received a single oral tablet of selexipag 200 mcg in the evening of Day 1 and continued the same dose (200 mcg) BID on Day 2. Upon first dose toleration, selexipag dose was up-titrated with weekly increments of 200 mcg until reaching the iMTD in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EDBT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 27.7 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate CYP2C8 inhibitor, the dosing frequency was to be QD.
|
Open Label Period: Selexipag (Ex-Placebo)
n=9 participants at risk
All participants (received placebo in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of OL treatment (EOLT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 20.8 months).
|
Open Label Period: Selexipag (Ex-Selexipag)
n=6 participants at risk
All participants (received selexipag in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EOLT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 19.8 months).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial Flutter
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Right Ventricular Failure
|
4.7%
3/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Discoloured Vomit
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Catheter Site Haematoma
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Death
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis Acute
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Covid-19 Pneumonia
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Bacterial
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic Shock
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tonsillitis
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral Cancer
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Double-blind Period: Placebo
n=64 participants at risk
Participants received a single oral tablet of placebo matching to selexipag 200 micrograms (mcg) in the evening of Day 1 and continued the same dose (200 mcg) twice daily (BID) on Day 2. Upon first dose toleration, placebo dose was up-titrated with weekly increments of 200 mcg until reaching the individual maximum tolerated dose (iMTD) in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of DB treatment (EDBT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 24.6 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate Cytochrome P-450 2C8 (CYP2C8) inhibitor, the dosing frequency was to be once daily (QD).
|
Double-blind Period: Selexipag
n=64 participants at risk
Participants received a single oral tablet of selexipag 200 mcg in the evening of Day 1 and continued the same dose (200 mcg) BID on Day 2. Upon first dose toleration, selexipag dose was up-titrated with weekly increments of 200 mcg until reaching the iMTD in the range of 200 to 1600 mcg BID. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EDBT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 27.7 months). For participants with moderate hepatic impairment (Child-Pugh B) or who were concomitantly taking a moderate CYP2C8 inhibitor, the dosing frequency was to be QD.
|
Open Label Period: Selexipag (Ex-Placebo)
n=9 participants at risk
All participants (received placebo in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to end of OL treatment (EOLT) period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 20.8 months).
|
Open Label Period: Selexipag (Ex-Selexipag)
n=6 participants at risk
All participants (received selexipag in DB period) who completed DB treatment period, entered OL extension period and received the first dose (selexipag 200 mcg) of OL period in the evening of the EDBT and then selexipag 200 mcg BID on the day after. Participants with moderate hepatic impairment (Child-Pugh B) or who had taken concomitantly moderate CYP2C8 inhibitor(s) started one tablet of OL selexipag 200 mcg in the morning of the day after EDBT visit. Dose up-titration was done as like DB treatment till iMTD was reached. The up-titration up to Week 12 was followed by a stable maintenance treatment period with the iMTD (reached at Week 12) until Week 26. After Week 26 up to EOLT period, further up-titration was done but not above 1600 mcg, BID (maximum duration: 19.8 months).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
4.7%
3/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
9.4%
6/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.1%
9/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
59.4%
38/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
55.6%
5/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
26.6%
17/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
33.3%
3/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
17.2%
11/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
33.3%
3/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
4.7%
3/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Chest Pain
|
4.7%
3/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
9.4%
6/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
4.7%
3/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema Peripheral
|
12.5%
8/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Covid-19
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
22.2%
2/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
9.4%
6/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Steroid Diabetes
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
21.9%
14/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
33.3%
3/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
5/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
10.9%
7/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
44.4%
4/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
20.3%
13/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
25.0%
16/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
22.2%
2/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
10.9%
7/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
12.5%
8/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
22.2%
2/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
21.9%
14/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
56.2%
36/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
66.7%
6/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
33.3%
2/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.1%
9/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
4.7%
3/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.6%
1/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Flushing
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
11.1%
1/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
16.7%
1/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
6.2%
4/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
3.1%
2/64 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/9 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
0.00%
0/6 • For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months)
Safety analysis set (SAF) included all participants who received at least one dose of study treatment.
|
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 30 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 to allow for filling of a patent application.
- Publication restrictions are in place
Restriction type: OTHER