Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
396
BAY63-2521: 1mg tid -2.5 mg tid oral until end of study
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
Time frame: From administration of first dose of study medication in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.
Number of Participant With Death
Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.
Time frame: From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit)
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation
Percentage of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation
Percentage of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
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Unnamed facility
Los Angeles, California, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
Unnamed facility
Omaha, Nebraska, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
Unnamed facility
Fairfield, Ohio, United States
Unnamed facility
Dallas, Texas, United States
...and 89 more locations
Time frame: From baseline to termination visit, up to 10 years
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
Percentage of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
Percentage of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to termination visit, up to 10 years