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Trial Outcomes & Findings for Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (NCT NCT03904693)

NCT ID: NCT03904693

Last Updated: 2025-12-19

Results Overview

Change in PVR expressed as the ratio of geometric means of EDBT to baseline were reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

187 participants

Primary outcome timeframe

Baseline, EDBT (up to 16 weeks)

Results posted on

2025-12-19

Participant Flow

In open label period, safety was presented using the combination safety set. Combination safety set included all participants randomized to macitentan/tadalafil fixed-dose combination (M/T FDC) in DB period and who received at least 1 dose of M/T FDC in DB treatment and all participants who received at least 1 dose of M/T FDC treatment in OL period.

Participant milestones

Participant milestones
Measure
DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive and Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
OL: Treatment-naive and Prior ERA Strata: M/T FDC
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA and received macitentan monotherapy during DB phase entered open label (OL) phase. During the OL phase participants received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching tadalafil 20 mg, orally, once daily for first 7 days (Week 17, titration phase). Subsequently participants received two tablets of tadalafil 20 mg along with one tablet of macitentan 10 mg, orally, once daily for 7 days (Week 18, titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of PDE-5i and received tadalafil monotherapy during DB phase entered OL phase. During the OL phase participants received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for the first 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
DB Treatment Period (Week 1 to Week 16)
STARTED
35
44
108
0
0
0
DB Treatment Period (Week 1 to Week 16)
Treated (Safety Analysis Set)
35
44
107
0
0
0
DB Treatment Period (Week 1 to Week 16)
Treatment Naive and Prior ERA Strata: M/T FDC
0
0
71
0
0
0
DB Treatment Period (Week 1 to Week 16)
Treatment Naive and Prior PDE-5i Strata: M/T FDC
0
0
87
0
0
0
DB Treatment Period (Week 1 to Week 16)
COMPLETED
35
43
99
0
0
0
DB Treatment Period (Week 1 to Week 16)
NOT COMPLETED
0
1
9
0
0
0
OL Treatment Period (Week 17 to Week189)
STARTED
0
0
0
35
43
91
OL Treatment Period (Week 17 to Week189)
COMPLETED
0
0
0
30
38
76
OL Treatment Period (Week 17 to Week189)
NOT COMPLETED
0
0
0
5
5
15

Reasons for withdrawal

Reasons for withdrawal
Measure
DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive and Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
OL: Treatment-naive and Prior ERA Strata: M/T FDC
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA and received macitentan monotherapy during DB phase entered open label (OL) phase. During the OL phase participants received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching tadalafil 20 mg, orally, once daily for first 7 days (Week 17, titration phase). Subsequently participants received two tablets of tadalafil 20 mg along with one tablet of macitentan 10 mg, orally, once daily for 7 days (Week 18, titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of PDE-5i and received tadalafil monotherapy during DB phase entered OL phase. During the OL phase participants received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for the first 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
DB Treatment Period (Week 1 to Week 16)
Death
0
0
3
0
0
0
DB Treatment Period (Week 1 to Week 16)
Physician Decision
0
0
2
0
0
0
DB Treatment Period (Week 1 to Week 16)
Withdrawal by Subject
0
1
4
0
0
0
OL Treatment Period (Week 17 to Week189)
Withdrawal by Subject
0
0
0
2
4
7
OL Treatment Period (Week 17 to Week189)
Death
0
0
0
0
0
5
OL Treatment Period (Week 17 to Week189)
Adverse Event
0
0
0
2
0
0
OL Treatment Period (Week 17 to Week189)
Initiated prohibited medication
0
0
0
1
0
0
OL Treatment Period (Week 17 to Week189)
Lost to Follow-up
0
0
0
0
0
1
OL Treatment Period (Week 17 to Week189)
Non-compliance with study drug
0
0
0
0
1
0
OL Treatment Period (Week 17 to Week189)
Technical problems
0
0
0
0
0
1
OL Treatment Period (Week 17 to Week189)
Family problems
0
0
0
0
0
1

Baseline Characteristics

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=35 Participants
During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive and Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=44 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
n=107 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
Total
n=186 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=8 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Age, Categorical
Between 18 and 65 years
27 Participants
n=8 Participants
34 Participants
n=6 Participants
87 Participants
n=6 Participants
148 Participants
n=9 Participants
Age, Categorical
>=65 years
8 Participants
n=8 Participants
10 Participants
n=6 Participants
20 Participants
n=6 Participants
38 Participants
n=9 Participants
Age, Continuous
51.3 years
STANDARD_DEVIATION 15.85 • n=8 Participants
53.1 years
STANDARD_DEVIATION 13.66 • n=6 Participants
48.7 years
STANDARD_DEVIATION 15.78 • n=6 Participants
50.2 years
STANDARD_DEVIATION 15.36 • n=9 Participants
Sex: Female, Male
Female
29 Participants
n=8 Participants
34 Participants
n=6 Participants
82 Participants
n=6 Participants
145 Participants
n=9 Participants
Sex: Female, Male
Male
6 Participants
n=8 Participants
10 Participants
n=6 Participants
25 Participants
n=6 Participants
41 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=8 Participants
5 Participants
n=6 Participants
8 Participants
n=6 Participants
15 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
n=8 Participants
39 Participants
n=6 Participants
95 Participants
n=6 Participants
164 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=8 Participants
0 Participants
n=6 Participants
4 Participants
n=6 Participants
7 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=8 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
1 Participants
n=9 Participants
Race (NIH/OMB)
Asian
12 Participants
n=8 Participants
11 Participants
n=6 Participants
36 Participants
n=6 Participants
59 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=8 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=8 Participants
2 Participants
n=6 Participants
2 Participants
n=6 Participants
5 Participants
n=9 Participants
Race (NIH/OMB)
White
20 Participants
n=8 Participants
29 Participants
n=6 Participants
66 Participants
n=6 Participants
115 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=8 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=8 Participants
2 Participants
n=6 Participants
2 Participants
n=6 Participants
6 Participants
n=9 Participants
Region of Enrollment
BRAZIL
5 Participants
n=8 Participants
3 Participants
n=6 Participants
4 Participants
n=6 Participants
12 Participants
n=9 Participants
Region of Enrollment
BULGARIA
0 Participants
n=8 Participants
2 Participants
n=6 Participants
2 Participants
n=6 Participants
4 Participants
n=9 Participants
Region of Enrollment
CANADA
0 Participants
n=8 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
2 Participants
n=9 Participants
Region of Enrollment
CHINA
5 Participants
n=8 Participants
5 Participants
n=6 Participants
13 Participants
n=6 Participants
23 Participants
n=9 Participants
Region of Enrollment
GERMANY
2 Participants
n=8 Participants
4 Participants
n=6 Participants
7 Participants
n=6 Participants
13 Participants
n=9 Participants
Region of Enrollment
ITALY
1 Participants
n=8 Participants
1 Participants
n=6 Participants
4 Participants
n=6 Participants
6 Participants
n=9 Participants
Region of Enrollment
JAPAN
1 Participants
n=8 Participants
1 Participants
n=6 Participants
6 Participants
n=6 Participants
8 Participants
n=9 Participants
Region of Enrollment
MALAYSIA
1 Participants
n=8 Participants
2 Participants
n=6 Participants
10 Participants
n=6 Participants
13 Participants
n=9 Participants
Region of Enrollment
MEXICO
2 Participants
n=8 Participants
2 Participants
n=6 Participants
6 Participants
n=6 Participants
10 Participants
n=9 Participants
Region of Enrollment
POLAND
3 Participants
n=8 Participants
2 Participants
n=6 Participants
7 Participants
n=6 Participants
12 Participants
n=9 Participants
Region of Enrollment
RUSSIAN FEDERATION
1 Participants
n=8 Participants
0 Participants
n=6 Participants
10 Participants
n=6 Participants
11 Participants
n=9 Participants
Region of Enrollment
SOUTH AFRICA
3 Participants
n=8 Participants
2 Participants
n=6 Participants
1 Participants
n=6 Participants
6 Participants
n=9 Participants
Region of Enrollment
SPAIN
3 Participants
n=8 Participants
2 Participants
n=6 Participants
3 Participants
n=6 Participants
8 Participants
n=9 Participants
Region of Enrollment
TAIWAN
3 Participants
n=8 Participants
2 Participants
n=6 Participants
6 Participants
n=6 Participants
11 Participants
n=9 Participants
Region of Enrollment
TURKEY
1 Participants
n=8 Participants
2 Participants
n=6 Participants
14 Participants
n=6 Participants
17 Participants
n=9 Participants
Region of Enrollment
UNITED STATES
4 Participants
n=8 Participants
13 Participants
n=6 Participants
13 Participants
n=6 Participants
30 Participants
n=9 Participants

PRIMARY outcome

Timeframe: Baseline, EDBT (up to 16 weeks)

Population: The full analysis set (FAS) included all randomized participants who received at least one dose of study treatment (for participants on FDC, at least one dose of either macitentan or tadalafil). Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) are counted twice as per planned analysis.

Change in PVR expressed as the ratio of geometric means of EDBT to baseline were reported.

Outcome measures

Outcome measures
Measure
DB: Treatment-naive And Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=35 Participants
During double-blind (BD) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior ERA Strata: M/T FDC
n=70 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=44 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC
n=86 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
Change in Pulmonary Vascular Resistance (PVR) Expressed as the Ratio of Geometric Means of End of Double-blind Treatment (EDBT) to Baseline
0.77 Ratio
Interval 0.69 to 0.87
0.55 Ratio
Interval 0.5 to 0.6
0.78 Ratio
Interval 0.72 to 0.84
0.56 Ratio
Interval 0.52 to 0.6

SECONDARY outcome

Timeframe: Baseline, EDBT (Week 16)

Population: The FAS included all randomized participants who received at least one dose of study treatment (for participants on FDC, at least one dose of either macitentan or tadalafil). Treatment-naive participants randomized to both macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC) arms (ERA and PDE-5i strata) are counted twice as per planned analysis.

Change from baseline to EDBT in 6MWD were reported. 6MWD was measured by 6-minute walk test (6MWT). The test measured the distance an individual was able to walk over a total of six minutes on a hard, flat surface with no obstacles. The goal was for the individual to walk as far as possible in 6 minutes.

Outcome measures

Outcome measures
Measure
DB: Treatment-naive And Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=35 Participants
During double-blind (BD) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior ERA Strata: M/T FDC
n=70 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=44 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC
n=86 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
Change From Baseline to EDBT in 6-minutes Walking Distance (6MWD)
38.5 Meters
Standard Deviation 70.42
52.9 Meters
Standard Deviation 88.23
15.9 Meters
Standard Deviation 45.04
43.4 Meters
Standard Deviation 78.03

SECONDARY outcome

Timeframe: Baseline, EDBT (Week 16)

Population: The PAH-SYMPACT symptoms analysis set included all participants included in the FAS for whom at least one baseline value of symptoms domain was provided. Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) were counted twice as per planned analysis.

Change from baseline in PAH-SYMPACT in cardiopulmonary symptom domain scores to EDBT were reported. PAH-SYMPACT was a pulmonary arterial hypertension (PAH)-specific patient-reported outcomes questionnaire that consists of 11 symptoms items, 11 impacts items and 1 item on oxygen use. The symptom items were divided into cardiopulmonary and cardiovascular domains, and the impact items were divided into physical and emotional/cognitive domains. Cardiopulmonary symptoms contain 6 items; shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area, and cough. Scores for the individual items were reported on a 5-point Likert scale, ranging from 0 (no symptom at all) to 4 (very severe symptoms), with higher scores indicated greater symptom severity.

Outcome measures

Outcome measures
Measure
DB: Treatment-naive And Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=33 Participants
During double-blind (BD) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior ERA Strata: M/T FDC
n=66 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=42 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC
n=81 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiopulmonary Symptom Domain Scores to EDBT
-0.14 Score on a scale
Standard Deviation 0.478
-0.20 Score on a scale
Standard Deviation 0.394
-0.13 Score on a scale
Standard Deviation 0.554
-0.15 Score on a scale
Standard Deviation 0.404

SECONDARY outcome

Timeframe: Baseline, EDBT (Week 16)

Population: The PAH-SYMPACT symptoms analysis set included all participants included in the FAS for whom at least one baseline value of symptoms domain was provided. Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) were counted twice as per planned analysis.

Change from baseline in PAH-SYMPACT in cardiovascular symptom domain scores to EDBT were reported. PAH-SYMPACT is a PAH-specific patient-reported outcomes questionnaire that consists of 11 symptoms items, 11 impacts items and 1 item on oxygen use. The symptom items were divided into cardiopulmonary and cardiovascular domains, and the impact items were divided into physical and emotional/cognitive domains. Cardiovascular symptoms contain 5 items; heart palpitations (heart fluttering), rapid heartbeat, chest pain, chest tightness, and lightheadedness. Scores for the individual items were reported on a 5-point Likert scale, ranging from 0 (no symptom at all) to 4 (very severe symptom), with higher scores indicated greater symptom severity.

Outcome measures

Outcome measures
Measure
DB: Treatment-naive And Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=33 Participants
During double-blind (BD) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior ERA Strata: M/T FDC
n=66 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=42 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC
n=81 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiovascular Symptom Domain Scores to EDBT
-0.14 Score on a scale
Standard Deviation 0.473
-0.15 Score on a scale
Standard Deviation 0.349
-0.18 Score on a scale
Standard Deviation 0.612
-0.10 Score on a scale
Standard Deviation 0.318

SECONDARY outcome

Timeframe: At Week 16 (EDBT)

Population: The FAS included all randomized participants who received at least one dose of study treatment (for participants on FDC, at least one dose of either macitentan or tadalafil). Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) are counted twice as per planned analysis. Here, 'N' overall (number of participants analyzed) signifies the number of participants evaluable, "n" (number analyzed) =number of participants evaluable for specified category.

Percentage of participants with absence of worsening in FC from baseline to EDBT were reported. The study was adaptive with two stages: Stage 1 and Stage 2. WHO functional classification (FC), PAH range from Class I (no limitation in physical activity, no dyspnea or fatigue, chest pain, or near syncope with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity), Class IV (cannot perform a physical activity without any symptoms, dyspnea and/or fatigue at rest).

Outcome measures

Outcome measures
Measure
DB: Treatment-naive And Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=18 Participants
During double-blind (BD) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior ERA Strata: M/T FDC
n=38 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=22 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC
n=47 Participants
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 1 : Class II
55.6 Percentage of participants
57.9 Percentage of participants
63.6 Percentage of participants
59.6 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 1 : Class III
38.9 Percentage of participants
23.7 Percentage of participants
31.8 Percentage of participants
25.5 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 1 : Missing
0 Percentage of participants
13.2 Percentage of participants
0 Percentage of participants
2.1 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 2: Class III
35.3 Percentage of participants
15.6 Percentage of participants
36.4 Percentage of participants
25.6 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 2 : Class IV
0 Percentage of participants
0 Percentage of participants
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 1 : Class IV
0 Percentage of participants
0 Percentage of participants
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 1 : Class I
5.6 Percentage of participants
Interval 0.59 to
5.3 Percentage of participants
Interval 0.561 to
4.5 Percentage of participants
Interval 0.522 to
12.8 Percentage of participants
Interval 0.546 to
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 2 : Class I
11.8 Percentage of participants
9.4 Percentage of participants
9.1 Percentage of participants
7.7 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 2 : Class II
52.9 Percentage of participants
75.0 Percentage of participants
54.5 Percentage of participants
61.5 Percentage of participants
Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT
Stage: 2 : Missing
0 Percentage of participants
0 Percentage of participants
0 Percentage of participants
5.1 Percentage of participants

Adverse Events

DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)

Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths

DB: Treatment-naive And Prior ERA Strata: M/T FDC

Serious events: 11 serious events
Other events: 49 other events
Deaths: 2 deaths

DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)

Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths

DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC

Serious events: 12 serious events
Other events: 58 other events
Deaths: 2 deaths

DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC

Serious events: 15 serious events
Other events: 72 other events
Deaths: 3 deaths

OL: Treatment-naive and Prior ERA Strata: M/T FDC

Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths

OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC

Serious events: 13 serious events
Other events: 38 other events
Deaths: 2 deaths

DB + OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC

Serious events: 39 serious events
Other events: 89 other events
Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure
DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=35 participants at risk
During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior ERA Strata: M/T FDC
n=70 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=44 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC
n=86 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
n=107 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
OL: Treatment-naive and Prior ERA Strata: M/T FDC
n=35 participants at risk
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA and received macitentan monotherapy during DB phase entered open label (OL) phase. During the OL phase participants received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching tadalafil 20 mg, orally, once daily for first 7 days (Week 17, titration phase). Subsequently participants received two tablets of tadalafil 20 mg along with one tablet of macitentan 10 mg, orally, once daily for 7 days (Week 18, titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC
n=43 participants at risk
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of PDE-5i and received tadalafil monotherapy during DB phase entered OL phase. During the OL phase participants received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for the first 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
DB + OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
n=107 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received macitentan 10 mg along with tadalafil 20 mg and placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
Blood and lymphatic system disorders
Anaemia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Blood and lymphatic system disorders
Normochromic Anaemia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Angina Pectoris
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Atrial Fibrillation
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Atrial Flutter
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Cardiac Failure
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Cor Pulmonale
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Coronary Artery Disease
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Left Ventricular Failure
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Palpitations
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Right Ventricular Failure
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Sinus Node Dysfunction
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Supraventricular Tachycardia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Eye disorders
Retinal Vein Occlusion
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Colitis Ischaemic
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Gastritis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Hiatus Hernia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Large Intestine Polyp
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Oesophageal Ulcer
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Subileus
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Tongue Cyst
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Varices Oesophageal
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Chest Pain
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Fatigue
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Peripheral Swelling
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Swelling Face
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Hepatobiliary disorders
Hepatic Cirrhosis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Hepatobiliary disorders
Portal Hypertension
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Abscess Bacterial
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Bronchitis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Cellulitis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Covid-19
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
5/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Covid-19 Pneumonia
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Diverticulitis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Gastroenteritis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Gastroenteritis Clostridial
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Influenza
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Parainfluenzae Virus Infection
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Pneumonia
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Pneumonia Viral
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Rhinovirus Infection
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Staphylococcal Bacteraemia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Viral Upper Respiratory Tract Infection
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Injury, poisoning and procedural complications
Femur Fracture
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Injury, poisoning and procedural complications
Humerus Fracture
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Injury, poisoning and procedural complications
Jaw Fracture
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Injury, poisoning and procedural complications
Overdose
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Injury, poisoning and procedural complications
Patella Fracture
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Injury, poisoning and procedural complications
Subdural Haematoma
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Greater Trochanteric Pain Syndrome
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Osteonecrosis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Systemic Scleroderma
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous Cystadenocarcinoma Ovary
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Nervous system disorders
Cerebral Infarction
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Nervous system disorders
Epilepsy
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Nervous system disorders
Hemiparesis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Nervous system disorders
Horner's Syndrome
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Nervous system disorders
Migraine
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Renal and urinary disorders
Glomerulonephritis Membranous
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Renal and urinary disorders
Renal Impairment
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Reproductive system and breast disorders
Endometrial Hyperplasia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Reproductive system and breast disorders
Endometriosis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Reproductive system and breast disorders
Intermenstrual Bleeding
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Reproductive system and breast disorders
Ovarian Cyst Ruptured
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Reproductive system and breast disorders
Uterine Polyp
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Asthma
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Autoimmune Lung Disease
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Pulmonary Veno-Occlusive Disease
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Vascular disorders
Hypotension
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.

Other adverse events

Other adverse events
Measure
DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)
n=35 participants at risk
During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior ERA Strata: M/T FDC
n=70 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)
n=44 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.
DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC
n=86 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
n=107 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.
OL: Treatment-naive and Prior ERA Strata: M/T FDC
n=35 participants at risk
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA and received macitentan monotherapy during DB phase entered open label (OL) phase. During the OL phase participants received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching tadalafil 20 mg, orally, once daily for first 7 days (Week 17, titration phase). Subsequently participants received two tablets of tadalafil 20 mg along with one tablet of macitentan 10 mg, orally, once daily for 7 days (Week 18, titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC
n=43 participants at risk
After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of PDE-5i and received tadalafil monotherapy during DB phase entered OL phase. During the OL phase participants received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for the first 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
DB + OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC
n=107 participants at risk
During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received macitentan 10 mg along with tadalafil 20 mg and placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.
Blood and lymphatic system disorders
Anaemia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.6%
6/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.0%
6/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.5%
8/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
11.4%
4/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
11.6%
5/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
12.1%
13/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Blood and lymphatic system disorders
Iron Deficiency Anaemia
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Cardiac disorders
Palpitations
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.5%
2/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.0%
3/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Diarrhoea
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
4/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
13.6%
6/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.8%
5/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
5/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Dyspepsia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
4/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.8%
3/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Gastritis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.6%
3/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.6%
3/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Nausea
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.1%
5/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.8%
3/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.5%
8/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Gastrointestinal disorders
Vomiting
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.3%
3/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.5%
2/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.4%
9/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Fatigue
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Non-Cardiac Chest Pain
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.8%
3/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Oedema Peripheral
11.4%
4/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
12.9%
9/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
11.4%
5/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
14.0%
12/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
13.1%
14/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
11.6%
5/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
15.0%
16/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Peripheral Swelling
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.6%
6/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.0%
6/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
General disorders
Pyrexia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
11.6%
5/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Covid-19
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.5%
2/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
20.0%
7/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
23.3%
10/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
23.4%
25/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Nasopharyngitis
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.5%
3/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Sinusitis
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Suspected Covid-19
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Upper Respiratory Tract Infection
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.2%
1/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
14.3%
5/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
14.0%
6/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
5/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Infections and infestations
Urinary Tract Infection
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
9.3%
4/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Investigations
Blood Glucose Increased
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Investigations
Haemoglobin Decreased
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.3%
3/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
9.3%
8/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.5%
8/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
11.4%
4/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
12.1%
13/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Metabolism and nutrition disorders
Hyperuricaemia
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
4/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.6%
3/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Arthralgia
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
9.1%
4/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.6%
3/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.0%
3/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.5%
8/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Back Pain
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.1%
5/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
9.1%
4/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.5%
3/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
5/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.93%
1/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.1%
5/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.5%
2/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
14.3%
5/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Musculoskeletal and connective tissue disorders
Pain in Extremity
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
9.1%
4/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Nervous system disorders
Dizziness
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
2/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.5%
3/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Nervous system disorders
Headache
17.1%
6/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
17.1%
12/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
13.6%
6/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
16.3%
14/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
16.8%
18/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.6%
3/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
21.5%
23/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Psychiatric disorders
Insomnia
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Cough
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.1%
5/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.5%
2/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.0%
6/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
11.6%
5/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
10.3%
11/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.4%
1/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.5%
2/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
2/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
1.9%
2/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
16.3%
7/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
5/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.3%
3/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.5%
3/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
2/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
5.6%
6/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Vascular disorders
Flushing
5.7%
2/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.3%
3/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.5%
3/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.8%
3/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
3.7%
4/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Vascular disorders
Hypotension
0.00%
0/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
7.1%
5/70 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
0.00%
0/44 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
4.7%
4/86 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
6.5%
7/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.9%
1/35 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
2.3%
1/43 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
8.4%
9/107 • DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.

Additional Information

Clinical Scientific Leader

Actelion Pharmaceuticals Ltd.

Phone: 844-434-4210

Results disclosure agreements

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