Trial Outcomes & Findings for Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP) (NCT NCT02138825)
NCT ID: NCT02138825
Last Updated: 2017-12-04
Results Overview
The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Baseline to 26 weeks
Results posted on
2017-12-04
Participant Flow
Overall, 229 participants were enrolled into the study centers in 19 countries worldwide, from 04-Jun-2014 (first patient first visit) to 14-Sep-2016 (last patient last visit).
A total of 147 participants were randomized and entered the main study phase, of whom 73 were assigned to riociguat and 74 to placebo.
Participant milestones
| Measure |
Riociguat (Adempas, BAY63-2521)
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
|---|---|---|
|
Main Study Treatment
STARTED
|
73
|
74
|
|
Main Study Treatment
COMPLETED
|
33
|
39
|
|
Main Study Treatment
NOT COMPLETED
|
40
|
35
|
|
Long-term Extension
STARTED
|
32
|
38
|
|
Long-term Extension
COMPLETED
|
0
|
0
|
|
Long-term Extension
NOT COMPLETED
|
32
|
38
|
|
Safety Follow-up
STARTED
|
72
|
64
|
|
Safety Follow-up
COMPLETED
|
50
|
47
|
|
Safety Follow-up
NOT COMPLETED
|
22
|
17
|
Reasons for withdrawal
| Measure |
Riociguat (Adempas, BAY63-2521)
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
|---|---|---|
|
Main Study Treatment
Adverse Event
|
11
|
3
|
|
Main Study Treatment
Death
|
1
|
2
|
|
Main Study Treatment
Protocol Violation
|
2
|
2
|
|
Main Study Treatment
Sponsor decision
|
12
|
18
|
|
Main Study Treatment
Study terminated by sponsor
|
10
|
9
|
|
Main Study Treatment
Withdrawal by Subject
|
3
|
1
|
|
Main Study Treatment
Medical decision
|
1
|
0
|
|
Long-term Extension
Study termination by sponsor
|
32
|
38
|
|
Safety Follow-up
Adverse Event
|
4
|
3
|
|
Safety Follow-up
Death
|
11
|
5
|
|
Safety Follow-up
Withdrawal by Subject
|
5
|
3
|
|
Safety Follow-up
clinic worsening
|
1
|
0
|
|
Safety Follow-up
withdrawal by PI
|
1
|
0
|
|
Safety Follow-up
logistical difficulties
|
0
|
1
|
|
Safety Follow-up
progressive disease
|
0
|
2
|
|
Safety Follow-up
too unwell to attend the visit
|
0
|
1
|
|
Safety Follow-up
treatment unblinded
|
0
|
1
|
|
Safety Follow-up
withdrawn due to lung transplant
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)
Baseline characteristics by cohort
| Measure |
Riociguat (Adempas, BAY63-2521)
n=73 Participants
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
n=74 Participants
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Customized
>=65 - <75 years
|
35 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Pulmonary hypertension (PH) subtype (Nice Clinical Classification)
PH owing to respiratory disease and /or hypoxia
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Pulmonary hypertension (PH) subtype (Nice Clinical Classification)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Classification of Idiopathic Interstitial Pneumonia
Idiopathic pulmonary fibrosis
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Classification of Idiopathic Interstitial Pneumonia
Idiopathic nonspecific interstitial pneumonia
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Classification of Idiopathic Interstitial Pneumonia
Resp. bronchiolitis-interstitial lung disease
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Classification of Idiopathic Interstitial Pneumonia
Cryptogenic organizing pneumonia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Classification of Idiopathic Interstitial Pneumonia
Acute interstitial pneumonia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Classification of Idiopathic Interstitial Pneumonia
Idiopathic lymphoid interstitial pneumonia
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Classification of Idiopathic Interstitial Pneumonia
Unclassifiable idiopathic interstitial pneumonias
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
World Health Organization (WHO) functional class
Class II
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
World Health Organization (WHO) functional class
Class III
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
World Health Organization (WHO) functional class
Class IV
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
6 minute walking distance (6MWD) category
< 320 m
|
43 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
6 minute walking distance (6MWD) category
>= 320 m and <380m
|
12 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
6 minute walking distance (6MWD) category
>= 380 m
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 26 weeksPopulation: Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.
The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=73 Participants
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
n=74 Participants
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
|---|---|---|
|
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26
|
3.63 Meter
Standard Deviation 60.80
|
-15.94 Meter
Standard Deviation 63.70
|
SECONDARY outcome
Timeframe: From baseline to week 26Population: Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); \>15% decrease in the 6MWD test; worsening of WHO functional class.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=73 Participants
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
n=74 Participants
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
|---|---|---|
|
Number of Participants With Clinical Worsening
No clinical event
|
39 Participants
|
38 Participants
|
|
Number of Participants With Clinical Worsening
>15% decrease in 6MWD
|
9 Participants
|
17 Participants
|
|
Number of Participants With Clinical Worsening
All-cause mortality
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Worsening
Hospitalization due to worsening CP status
|
15 Participants
|
7 Participants
|
|
Number of Participants With Clinical Worsening
Worsening of WHO functional class
|
9 Participants
|
12 Participants
|
POST_HOC outcome
Timeframe: From start of treatment to end of studyPopulation: Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.
In the main study treatment phase participants received Riociguat until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants continued with Riociguat treatment. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=73 Participants
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
|---|---|---|
|
Number of Deaths Per Study Phase for Riociguat Group
Main study treatment
|
8 Participants
|
—
|
|
Number of Deaths Per Study Phase for Riociguat Group
Long-term extension
|
1 Participants
|
—
|
|
Number of Deaths Per Study Phase for Riociguat Group
Safety follow-up
|
3 Participants
|
—
|
POST_HOC outcome
Timeframe: From start of treatment to end of studyPopulation: Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.
In the main study treatment phase participants received Placebo until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants were treated with Riociguat. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=74 Participants
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
|---|---|---|
|
Number of Deaths Per Study Phase for Placebo Group
Main study treatment
|
3 Participants
|
—
|
|
Number of Deaths Per Study Phase for Placebo Group
Long-term extension: received Riociguat
|
8 Participants
|
—
|
|
Number of Deaths Per Study Phase for Placebo Group
Safety follow-up: only treated with Placebo
|
3 Participants
|
—
|
|
Number of Deaths Per Study Phase for Placebo Group
Safety follow-up: received Riociguat in LTE
|
1 Participants
|
—
|
POST_HOC outcome
Timeframe: From start of safety follow-up phase until end of studyPopulation: Safety analysis set: participants randomized and received at least one dose of study medication.
At the time of study termination, all participants entered safety follow-up phase regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=73 Participants
In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
Placebo
n=74 Participants
In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
|
|---|---|---|
|
Number of Serious Adverse Events During Safety Follow-up Phase
|
18 Participants
|
14 Participants
|
Adverse Events
Riociguat up to 2.5 mg Tid
Serious events: 27 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo
Serious events: 17 serious events
Other events: 52 other events
Deaths: 0 deaths
Riociguat-Riociguat Transition
Serious events: 12 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo-Riociguat Transition
Serious events: 21 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Riociguat up to 2.5 mg Tid
n=73 participants at risk
Reporting group 1 (RG 1): All participants randomized to Riociguat treatment in Main study treatment phase (data until week 26); participants received Riociguat titrated to optimal dose within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Riociguat Arm of Period 1 in Participant Flow section.
|
Placebo
n=74 participants at risk
Reporting group 2 (RG 2): All participants randomized to Placebo treatment in Main study treatment phase (data until week 26); participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Placebo Arm of Period 1 in Participant Flow section.
|
Riociguat-Riociguat Transition
n=32 participants at risk
Reporting group 3 (RG 3): All participants that were initially randomized to Riociguat treatment in Main study treatment phase and later entered Long-term extension (LTE) phase (data starting from week 26 to study termination); participants received a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Riociguat Arm of Period 2 in Participant Flow section.
|
Placebo-Riociguat Transition
n=38 participants at risk
Reporting group 4 (RG 4): All participants that were initially randomized to Placebo treatment in Main study treatment phase and later entered LTE phase (data starting from week 26 to study termination); participants received a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Placebo Arm of Period 2 in Participant Flow section.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Surgical and medical procedures
Lung transplant
|
2.7%
2/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Vascular disorders
Hypotension
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.5%
4/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
2.7%
2/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Angina unstable
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Atrial tachycardia
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Nodal rhythm
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Right ventricular failure
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
General disorders
Chest pain
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
General disorders
Oedema
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
General disorders
Oedema peripheral
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Bronchitis
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Herpes zoster
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Influenza
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Pneumonia
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.5%
4/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Pneumonia moraxella
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Lung infection
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Cerebral artery thrombosis
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Loss of consciousness
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
4.1%
3/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.4%
3/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
Other adverse events
| Measure |
Riociguat up to 2.5 mg Tid
n=73 participants at risk
Reporting group 1 (RG 1): All participants randomized to Riociguat treatment in Main study treatment phase (data until week 26); participants received Riociguat titrated to optimal dose within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Riociguat Arm of Period 1 in Participant Flow section.
|
Placebo
n=74 participants at risk
Reporting group 2 (RG 2): All participants randomized to Placebo treatment in Main study treatment phase (data until week 26); participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Placebo Arm of Period 1 in Participant Flow section.
|
Riociguat-Riociguat Transition
n=32 participants at risk
Reporting group 3 (RG 3): All participants that were initially randomized to Riociguat treatment in Main study treatment phase and later entered Long-term extension (LTE) phase (data starting from week 26 to study termination); participants received a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Riociguat Arm of Period 2 in Participant Flow section.
|
Placebo-Riociguat Transition
n=38 participants at risk
Reporting group 4 (RG 4): All participants that were initially randomized to Placebo treatment in Main study treatment phase and later entered LTE phase (data starting from week 26 to study termination); participants received a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Placebo Arm of Period 2 in Participant Flow section.
|
|---|---|---|---|---|
|
Cardiac disorders
Right ventricular failure
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Constipation
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.1%
11/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.5%
7/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
12.5%
4/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
13.2%
5/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Nausea
|
13.7%
10/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
12.2%
9/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
12.5%
4/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
13.2%
5/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Vomiting
|
11.0%
8/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.4%
3/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.5%
4/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
General disorders
Chest pain
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.8%
5/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
General disorders
Fatigue
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.5%
7/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.4%
3/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
General disorders
Oedema peripheral
|
20.5%
15/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.5%
7/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
15.6%
5/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
13.2%
5/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Bronchitis
|
2.7%
2/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
4.1%
3/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Influenza
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
5/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.4%
4/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.4%
4/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Urinary tract infection
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Respiratory tract infection
|
8.2%
6/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
8.1%
6/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Investigations
Blood glucose increased
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.5%
4/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.5%
7/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.5%
4/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
4.1%
3/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Dizziness
|
9.6%
7/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.8%
8/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
15.6%
5/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
13.2%
5/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Headache
|
11.0%
8/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
12.2%
9/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Presyncope
|
2.7%
2/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Syncope
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.5%
4/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Psychiatric disorders
Insomnia
|
2.7%
2/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
10.5%
4/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.4%
3/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.0%
8/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
13.5%
10/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.0%
8/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.5%
7/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
18.8%
6/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
28.9%
11/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
5/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.5%
7/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.7%
2/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
2.7%
2/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.4%
3/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.4%
4/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Vascular disorders
Hypotension
|
5.5%
4/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
9.4%
3/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
18.4%
7/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
7.9%
3/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
3.1%
1/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.1%
3/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
0.00%
0/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
5.3%
2/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/73 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
1.4%
1/74 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
6.2%
2/32 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
2.6%
1/38 • Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Written consent must be obtained from Bayer prior to any information being submitted for publication. Material proposed for publication or presentation must be provided to Bayer prior to submission. All reasonable comments made by the Sponsor in relation to a proposed publication by the Investigator will be incorporated by the Investigator into the publication.
- Publication restrictions are in place
Restriction type: OTHER