Single Dose Study in Patients With Chronic Obstructive Pu... | NCT00640315

ID	Type	Description	Link
2007-003919-31	EudraCT Number

Label	Type	Description	Intervention Names
Riociguat (Adempas, BAY63-2521) 1.0 mg	Experimental	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.	Drug: Riociguat (Adempas, BAY63-2521) 1.0 mg
Riociguat (Adempas, BAY63-2521) 2.5 mg	Experimental	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.	Drug: Riociguat (Adempas, BAY63-2521) 2.5 mg

Name	Type	Description	Arm Group Labels	Other Names
Riociguat (Adempas, BAY63-2521) 1.0 mg	Drug	1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).

Measure	Description	Time Frame
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)	PAPmean was reported during right heart catheterization	From baseline up to 4 hours after administration
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)	PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output	From baseline up to 4 hours after administration
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat		Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat		Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kg Body Weight (AUCnorm) of Riociguat and Metabolite M1 After Single Dose of Riociguat		Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat		Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat

Measure	Description	Time Frame
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)	RAPmean was reported during right heart catheterization	From baseline up to 4 hours after administration
Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)

Measure	Description	Time Frame
Mean PR Duration (PRmean) - Change From Baseline to Day 3	PR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.	Baseline and day 3
Mean QRS Duration (QRSmean) - Change From Baseline to Day 3

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Heidelberg	Baden-Wurttemberg	69126	Germany

PubMed Identifier	Type	Citation	Retractions
	Result	H.-A. Ghofrani, G. Staehler, E. Gruenig, M. Halank, V. Mitrovic, S. Unger, W. Mueck, R. Frey, J. Behr. The Effect Of The Soluble Guanylate Cyclase Stimulator Riociguat On Hemodynamics In Patients With Pulmonary Hypertension Due To Chronic Obstructive Pulmonary Disease. D96 CLINICAL TRIALS AND OUTCOMES IN PULMONARY HYPERTENSION.

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.	View source

ID	Title	Description
FG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
FG001	Riociguat (Adempas, BAY63-2521) 2.5 mg

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)

PAPmean was reported during right heart catheterization

per-protocol population

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG00010 OG00112

Title

Denominators

Categories

Title	Measurements
	OG000-3.60± 3.41 OG001-4.83± 4.17

Primary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)

PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

(dyn*s*cm^-5)

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Primary

Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

µg*h/L

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Primary

Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

10^3*h/L

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Primary

Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kg Body Weight (AUCnorm) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

kg*h/L

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Primary

Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/L

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Primary

Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

10^3/L

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Primary

Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

kg/L

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)

RAPmean was reported during right heart catheterization

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)

PAPsyst was acquired during right heart catheterization

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)

PAPdiast was acquired during right heart catheterization

per-protocol population

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)

PCWP was acquired during right heart catheterization

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)

HR was acquired during right heart catheterization

per-protocol population

Posted

Mean

Standard Deviation

beats per minute

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)

Systolic arterial blood pressure was acquired during right heart catheterization.

per-protocol population

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)

Diastolic arterial blood pressure was acquired during right heart catheterization.

per-protocol population

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)

MAP was acquired during right heart catheterization

per-protocol population

Posted

Mean

Standard Deviation

mmHg

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)

CO was measured in triplicate by the thermodilution technique

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

L/min

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)

PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

dyn*s*cm^-5*m^2

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)

SVR was calculated as SVR = 80*(MAP-RAPmean)/CO

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

dyn*s*cm^-5

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)

SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

dyn*s*cm^-5*m^2

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index

Cardiac index was calculated as cardiac index = CO / body surface area.

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

L/min/m^2

From baseline up to 4 hours after administration

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)

Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)

Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)

Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)

Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)

Percent change was calculated as "100%*(value post dose - value at baseline)/ value at baseline".

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Expiratory Volume in 1 Second (FEV1)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC

The percent of predicted TLC was provided by investigator at site.

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 75% of Expiratory Vital Capacity (MEF75)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 50% of Expiratory Vital Capacity (MEF50)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 25% of Expiratory Vital Capacity (MEF25)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity at the Time When the DLCO is Measured (Alveolar Volume, VA)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 2 hours post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Ventilation (V)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

L/min

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Perfusion (Q)

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

L/min

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Dead Space Ventilation

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage of total ventilation

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Low V/Q Perfusion

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Normal V/Q Perfusion

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hours Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Perfusion

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

L/MIN

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Ventilation

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

L/MIN

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Intrapulmonary Shunt Flow

per-protocol population (subjects with data available for this outcome measure)

Posted

Mean

Standard Deviation

Percentage of total perfusion

Baseline and 1 hour post dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Median

Full Range

hour

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Half-life Associated With the Terminal Slope (t1/2) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

hour

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Mean Residence Time (MRT) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

hour

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration Verse Time Curve From Zero to the Last Data Point (AUC0-tn) of Riociguat and Metabolite M1 After Single Dose of Riociguat

per-protocol population

Posted

Geometric Mean

Geometric Coefficient of Variation

µg*h/L

Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Other Pre-specified

Mean PR Duration (PRmean) - Change From Baseline to Day 3

PR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.

All subjects who received at least one dose of the trial medication were included in the safety evaluation.

Posted

Mean

Standard Deviation

msec

Baseline and day 3

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Other Pre-specified

Mean QRS Duration (QRSmean) - Change From Baseline to Day 3

QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.

All subjects who received at least one dose of the trial medication were included in the safety evaluation.

Posted

Mean

Standard Deviation

msec

Baseline and day 3

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Other Pre-specified

Mean QT Duration (QTmean) - Change From Baseline to Day 3

QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.

All subjects who received at least one dose of the trial medication were included in the safety evaluation.

Posted

Mean

Standard Deviation

msec

Baseline and day 3

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Other Pre-specified

Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3

Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.

All subjects who received at least one dose of the trial medication were included in the safety evaluation.

Posted

Mean

Standard Deviation

msec

Baseline and day 3

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

Other Pre-specified

Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3

Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.

All subjects who received at least one dose of the trial medication were included in the safety evaluation.

Posted

Mean

Standard Deviation

msec

Baseline and day 3

ID	Title	Description
OG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
OG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.			0	10	4	10
EG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.			2	13	6	13

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment		EG0000 affected10 at risk EG0011 affected13 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (12.1)	Systematic Assessment		EG0000 affected10 at risk EG0011 affected13 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Palpitations	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Visual impairment	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
C-reactive protein increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected10 at risk EG0011 affected13 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk

ID	Term
D006976	Hypertension, Pulmonary
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D008173	Lung Diseases, Obstructive
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Riociguat (Adempas, BAY63-2521) 1.0 mg	Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
BG001	Riociguat (Adempas, BAY63-2521) 2.5 mg	Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
BG002	Total	Total of all reporting groups