Trial Outcomes & Findings for Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis (NCT NCT02283762)
NCT ID: NCT02283762
Last Updated: 2020-02-05
Results Overview
The mRSS is a validated physical examination method for estimating skin thickness. It correlates with biopsy measures of collagen in the dermis and reflects prognosis and visceral involvement, especially in early disease. It is scored on 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 (higher score means worse situation) and is used to categorize severity of SSc. A decrease in the mean change of mRSS shows mRSS improved.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Baseline to week 52
Results posted on
2020-02-05
Participant Flow
The study was conducted between 15 January 2015 (first patient first visit) and 28 March 2019 (last patient last visit). The Main Treatment Phase has been conducted between 15 Jan 2015 (first subject first visit) and 03 Jan 2018 (last subject last visit for the main treatment phase).
139 patients were screened in 60 study centers in 15 countries worldwide. 121 patients of 139 patients were randomized and treated with at least one dose of study medication. 88 of the 121 randomized patients completed the treatment phase, of whom 87 entered the long term extension (LTE) phase.
Participant milestones
| Measure |
Riociguat (Adempas, BAY63-2521)
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
Main Treatment Phase (MT)
STARTED
|
60
|
61
|
|
Main Treatment Phase (MT)
COMPLETED
|
42
|
46
|
|
Main Treatment Phase (MT)
NOT COMPLETED
|
18
|
15
|
|
Long-term Extension Phase (LTE)
STARTED
|
42
|
45
|
|
Long-term Extension Phase (LTE)
COMPLETED
|
32
|
31
|
|
Long-term Extension Phase (LTE)
NOT COMPLETED
|
10
|
14
|
Reasons for withdrawal
| Measure |
Riociguat (Adempas, BAY63-2521)
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
Main Treatment Phase (MT)
Adverse Event
|
9
|
9
|
|
Main Treatment Phase (MT)
Lack of Efficacy
|
1
|
0
|
|
Main Treatment Phase (MT)
Physician Decision
|
1
|
1
|
|
Main Treatment Phase (MT)
Pregnancy
|
0
|
1
|
|
Main Treatment Phase (MT)
Withdrawal by Subject
|
7
|
4
|
|
Long-term Extension Phase (LTE)
Adverse Event
|
2
|
6
|
|
Long-term Extension Phase (LTE)
Lack of Efficacy
|
1
|
1
|
|
Long-term Extension Phase (LTE)
Study terminated at site
|
1
|
0
|
|
Long-term Extension Phase (LTE)
Withdrawal by Subject
|
4
|
3
|
|
Long-term Extension Phase (LTE)
Protocol Violation
|
1
|
1
|
|
Long-term Extension Phase (LTE)
Lost to Follow-up
|
0
|
1
|
|
Long-term Extension Phase (LTE)
Physician Decision
|
1
|
2
|
Baseline Characteristics
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
Baseline characteristics by cohort
| Measure |
Riociguat (Adempas, BAY63-2521)
n=60 Participants
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
n=61 Participants
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
49.5 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
50.7 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
59 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Modified Rodnan skin score (mRSS)
|
16.9 score on a scale
STANDARD_DEVIATION 3.4 • n=99 Participants
|
16.7 score on a scale
STANDARD_DEVIATION 4.1 • n=107 Participants
|
16.8 score on a scale
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Forced vital capacity (FVC) percent predicted
|
90.743 FVC percent predicted
STANDARD_DEVIATION 18.523 • n=99 Participants
|
94.823 FVC percent predicted
STANDARD_DEVIATION 17.034 • n=107 Participants
|
92.800 FVC percent predicted
STANDARD_DEVIATION 17.832 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 52Population: Full analysis set (FAS: all participants randomized and treated with study medication) with evaluable data for this outcome measure.
The mRSS is a validated physical examination method for estimating skin thickness. It correlates with biopsy measures of collagen in the dermis and reflects prognosis and visceral involvement, especially in early disease. It is scored on 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 (higher score means worse situation) and is used to categorize severity of SSc. A decrease in the mean change of mRSS shows mRSS improved.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=57 Participants
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
n=52 Participants
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52
|
-2.088 score on a scale
Standard Deviation 5.658
|
-0.769 score on a scale
Standard Deviation 8.243
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set (FAS)
CRISS forms a composite response index consisting of SSc-related organ involvement and the following five variables: mRSS, FVC percent predicted, physician's and patient's global assessments, and HAQ-DI score (from SHAQ patient-reported outcome). The resulting index is a 2-step process that captures clinically meaningful worsening of internal organ involvement and the core variables that show change. Patients for whom the predicted CRISS probability was ≥ 0.60 were considered improved, while patients for whom the predicted probability was \< 0.60 were considered not improved.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=60 Participants
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
n=61 Participants
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52
CRISS probability < 0.60
|
49 Participants
|
50 Participants
|
|
CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52
CRISS probability ≥ 0.60
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: FAS with evaluable data for this outcome measure.
The HAQ-DI is a composite measure from which a 'Standard Disability Index' score can be computed to assess a patient's disability level. Generally, a score of 0-1 represents mild to moderate difficulty, 1-2 moderate to severe disability and 2-3 severe to very severe disability. The HAQ-DI comprises 20 items that assess patient abilities across 8 functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item is rated on a 4-point scale: 0=Without ANY difficulty, 1=With SOME difficulty, 2=With MUCH difficulty, 3=UNABLE to do. The 8 scores of the 8 sections are summed and divided by 8. In the event that one section is not completed by a subject then the summed score would be divided by 7. The final overall HAQ-DI score ranges from 0 to 3 and positive change indicates worse health-related quality of life (HRQoL).
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=60 Participants
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
n=61 Participants
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52
Baseline
|
0.888 score on a scale
Standard Deviation 0.665
|
0.693 score on a scale
Standard Deviation 0.688
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52
Change from baseline
|
0.054 score on a scale
Standard Deviation 0.381
|
0.127 score on a scale
Standard Deviation 0.418
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: FAS with evaluable data for this outcome measure.
The patient's global assessments (a self-report) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the patient's global assessments score indicates worsening.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=60 Participants
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
n=61 Participants
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
Change From Baseline in Patient's Global Assessment Score to Week 52
Baseline
|
3.933 score on a scale
Standard Deviation 2.497
|
3.770 score on a scale
Standard Deviation 2.341
|
|
Change From Baseline in Patient's Global Assessment Score to Week 52
Change from baseline
|
0.689 score on a scale
Standard Deviation 2.745
|
-0.022 score on a scale
Standard Deviation 2.226
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: FAS with evaluable data for this outcome measure.
The physician's global assessments (reported by the physician) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the physician's global assessments score indicates worsening.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=60 Participants
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
n=61 Participants
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
Change From Baseline in Physician's Global Assessment Score to Week 52
Baseline
|
4.333 score on a scale
Standard Deviation 2.105
|
4.016 score on a scale
Standard Deviation 2.004
|
|
Change From Baseline in Physician's Global Assessment Score to Week 52
Change from baseline
|
-0.067 score on a scale
Standard Deviation 2.157
|
-0.745 score on a scale
Standard Deviation 2.090
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: FAS with evaluable data for this outcome measure.
Negative change in FVC percent predicted indicates worsening.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=55 Participants
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo
n=51 Participants
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52
|
-2.376 FVC percent predicted
Standard Deviation 7.515
|
-2.945 FVC percent predicted
Standard Deviation 9.727
|
Adverse Events
Riociguat-Riociguat (LTE Phase)
Serious events: 10 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo-Riociguat (LTE Phase)
Serious events: 11 serious events
Other events: 39 other events
Deaths: 0 deaths
Riociguat (Main Treatment Phase)
Serious events: 9 serious events
Other events: 55 other events
Deaths: 1 deaths
Placebo (Main Treatment Phase)
Serious events: 15 serious events
Other events: 49 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Riociguat-Riociguat (LTE Phase)
n=42 participants at risk
Main treatment phase: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting from Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo-Riociguat (LTE Phase)
n=45 participants at risk
Main treatment phase: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting from Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Riociguat (Main Treatment Phase)
n=60 participants at risk
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo (Main Treatment Phase)
n=61 participants at risk
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
General disorders
Inflammation
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Lung infection
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Renal and urinary disorders
Scleroderma renal crisis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Surgical and medical procedures
Prophylaxis
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Extrasystoles
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Haematemesis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.4%
1/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Appendicitis
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Localised infection
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Salpingitis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Sepsis
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Staphylococcal infection
|
2.4%
1/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Bursitis infective
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Device related sepsis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Medical device site joint infection
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Investigations
Ultrasound kidney abnormal
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Systemic scleroderma
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Surgical and medical procedures
Rhinoplasty
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
Other adverse events
| Measure |
Riociguat-Riociguat (LTE Phase)
n=42 participants at risk
Main treatment phase: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting from Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo-Riociguat (LTE Phase)
n=45 participants at risk
Main treatment phase: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting from Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Riociguat (Main Treatment Phase)
n=60 participants at risk
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
Placebo (Main Treatment Phase)
n=61 participants at risk
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham-titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
|
|---|---|---|---|---|
|
General disorders
Peripheral swelling
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.3%
5/60 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.2%
5/61 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Bronchitis
|
11.9%
5/42 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Nasopharyngitis
|
26.2%
11/42 • Number of events 13 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
22.2%
10/45 • Number of events 10 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.3%
5/60 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.2%
5/61 • Number of events 8 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Cardiac disorders
Palpitations
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.3%
8/60 • Number of events 8 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.9%
3/61 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.9%
4/45 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.2%
5/61 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Constipation
|
9.5%
4/42 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.6%
4/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
5/42 • Number of events 11 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
17.8%
8/45 • Number of events 23 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
16.7%
10/60 • Number of events 15 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.1%
8/61 • Number of events 11 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.7%
7/60 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
10.0%
6/60 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
7/42 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
17.8%
8/45 • Number of events 8 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
25.0%
15/60 • Number of events 16 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.5%
7/61 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.3%
6/45 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.7%
7/60 • Number of events 9 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
9.8%
6/61 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
7/42 • Number of events 11 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.9%
4/45 • Number of events 14 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.3%
8/60 • Number of events 14 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
9.8%
6/61 • Number of events 8 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
General disorders
Asthenia
|
4.8%
2/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.9%
3/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
General disorders
Fatigue
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.9%
4/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.7%
7/60 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
9.8%
6/61 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
General disorders
Oedema peripheral
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
10.0%
6/60 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
General disorders
Pain
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
General disorders
Pyrexia
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.6%
4/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
7/42 • Number of events 10 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.3%
6/45 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.1%
8/61 • Number of events 10 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
4/42 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.3%
6/45 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
20.0%
12/60 • Number of events 14 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.1%
8/61 • Number of events 9 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
2/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.6%
4/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
2/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
4/42 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.3%
6/45 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
21.7%
13/60 • Number of events 21 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.5%
7/61 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.9%
4/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
18.3%
11/60 • Number of events 12 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
19.7%
12/61 • Number of events 16 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.6%
4/61 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Psychiatric disorders
Insomnia
|
4.8%
2/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
6/42 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
15.0%
9/60 • Number of events 9 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.2%
5/61 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
13.3%
8/60 • Number of events 9 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.2%
5/61 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
2/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
2.2%
1/45 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
11.9%
5/42 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.1%
5/45 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.8%
2/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.6%
4/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.3%
5/60 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.2%
5/61 • Number of events 9 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
5.0%
3/60 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
14.3%
6/42 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.9%
4/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
4/60 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.5%
7/61 • Number of events 9 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.6%
4/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Vascular disorders
Hypotension
|
11.9%
5/42 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
15.6%
7/45 • Number of events 9 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.7%
7/60 • Number of events 7 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.6%
4/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.9%
4/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.9%
3/61 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.1%
3/42 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Gastroenteritis
|
4.8%
2/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
11.1%
5/45 • Number of events 6 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Influenza
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
8.9%
4/45 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Infections and infestations
Pneumonia
|
7.1%
3/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/45 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
2/42 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/60 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.6%
1/61 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.8%
2/42 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
4/42 • Number of events 5 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.4%
2/45 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
1.7%
1/60 • Number of events 1 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
4.9%
3/61 • Number of events 3 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/42 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
6.7%
3/45 • Number of events 4 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
3.3%
2/60 • Number of events 2 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
0.00%
0/61 • From first application of study drug up to 2 days after end of treatment with study drug, up to 4 years.
All 42 patients who completed the main treatment phase from the riociguat group entered the LTE phase and continued to receive riociguat. This group is referred in the LTE phase to "riociguat-riociguat group". One of the 46 patients from the placebo group did not enter the LTE phase. This group is referred to "placebo-riociguat group".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any proposed publications should be sent to Bayer for review at least 40 days before forwarding to any person that is not bound by the confidentially obligations. Bayer may request delay of publication for no more than 120 days to allow for filing Patent Applications (if applicable). No publication of single center data should be done prior to publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER