BAY63-2521:Long-term Extension Study in Patients With Pul... | NCT00863681

NCT00863681

ID	Type	Description	Link
2008-003610-94	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Riociguat (BAY63-2521)

Name	Type	Description	Arm Group Labels	Other Names
Riociguat (BAY63-2521)	Drug	BAY63-2521: 1mg tid -2.5 mg tid oral until end of study	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit)

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Measure	Description	Time Frame
Change of Systolic Blood Pressure (SBP)	SBP was measured after the participant had been at rest for 10 minutes in a supine position. Low SBP was defined as SBP <95 mmHg, normal SBP as SBP 95-140mmHg, and high SBP as SBP >140 mmHg. 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.	From baseline to termination visit, up to 10 years

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90073	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34848133	Background	Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.
35256218

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
FG001	Riociguat-Former Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 13, 2012	Sep 29, 2020

Arm/Group Information

ID	Title	Description
BG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
BG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
BG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00050.4± 16.4 BG00148.8± 15.9 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000186 BG00187 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000148 BG00166 BG002

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

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.

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Units	Counts
Participants	OG000231 OG001109 OG00256

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG000229 OG001108 OG00256

Any drug-related TEAE

Primary

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.

Posted

Count of Participants

Participants

From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit)

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Units	Counts

Secondary

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.

Participants in SAF with evaluable data for each visit, and for each parameter.

Posted

Number

Percentage of participants

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002

Secondary

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.

Participants in SAF with evaluable data for each visit, and for each parameter.

Posted

Number

Percentage of participants

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002

Secondary

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.

Participants in SAF with evaluable data for each visit, and for each parameter.

Posted

Number

Percentage of participants

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002

Secondary

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.

Participants in SAF with evaluable data for each visit, and for each parameter.

Posted

Number

Percentage of participants

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002

Other Pre-specified

Change of Systolic Blood Pressure (SBP)

SBP was measured after the participant had been at rest for 10 minutes in a supine position. Low SBP was defined as SBP <95 mmHg, normal SBP as SBP 95-140mmHg, and high SBP as SBP >140 mmHg.

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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

millimetre(s) of mercury (mmHg)

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of Diastolic Blood Pressure (DBP)

DBP was measured after the participants had been at rest for 10 minutes in a supine position.

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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

mmHg

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of Heart Rate

Heart rate was measured after the participant had been at rest for 10 minutes in a supine position.

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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

beats/minute (BPM)

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of Weight

Weight was evaluated for safety. 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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

kilogram (kg)

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of Oxygen Saturation (SaO2)

SaO2 is one parameters of blood gas. The sample was obtained with the participant resting in a sitting or supine position for at least 10 minutes.

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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

Percentage

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of Arterial Partial Oxygen Pressure (PaO2)

PaO2 is one parameter of blood gas. The sample was obtained with the participant resting in a sitting or supine position for at least 10 minutes.

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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

mmHg

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of Arterial Partial Pressure of Carbon Dioxide (PaCO2)

PaCO2 is one parameter of blood gas. The sample was obtained with the participant resting in a sitting or supine position for at least 10 minutes.

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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

mmHg

From baseline to termination visit, up to 10 years

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of RR Duration From Electrocardiogram (ECG)

Heart rate from ECG is derived from the RR duration, unless arrhythmias such as atrial fibrillation or ventricular extra beats require additional calculations. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.

Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

millisecond (msec)

From baseline to Month 48

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of PR Duration From ECG

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

Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

msec

From baseline to Month 48

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of QRS Duration From ECG

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

Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

msec

From baseline to Month 48

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change of QT Duration in ECG

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

Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

msec

From baseline to Month 48

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change in Six-minute Walking Distance (6MWD) Test

6MWD is exercise testing and is one of efficacy evaluation

Posted

Median

Full Range

meters

From baseline to End of study visit, up to 10 years and 5 months.

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Units	Counts
Participants

Other Pre-specified

Change in Pulmonary Vascular Resistance (PVR)

Pulmonary vascular resistance (PVR) was measured only if right-heart catheterization was performed as part of a regular diagnostic work-up.

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.

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

dyn*s*cm^-5

From baseline to Termination visit, up to 10 years 5 months

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)

NT-proBNP levels in the blood are used for diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

picograms/millilitre (pg/mL)

From baseline to End of study visit, up to 10 year and 5 months

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change in World Health Organization (WHO) Functional Class

WHO classification: I: Participants with PH. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope. II: Participants with PH are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope. III: Participants with PH are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope. IV: Participants with PH with inability to carry out any physical activity. They manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. For class change from baseline, minus indicates a participant's functional class decreased compared with baseline (e.g. "-1" indicates a participant changed from class IV to class III, or from class II to class I), plus indicates a participant's functional class increased compared with baseline (e.g. "+1" indicates a participant changed from class I to class II, or from class III to class IV).

Participants in SAF with evaluable data for each visit

Posted

Count of Participants

Participants

From baseline to End of study visit, up to 10 years and 5 months.

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo

Other Pre-specified

Number of Participants With Clinical Worsening

Time to clinical worsening was a parameter that combined death and events reflective of persistent clinical worsening of the participant's underlying diagnosis of pulmonary hypertension (PH)

Posted

Count of Participants

Participants

From baseline to End of study visit, up to 10 years and 5 months.

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Units	Counts

Other Pre-specified

Incidence of Clinical Worsening Events Per 100 Person Years

Time to clinical worsening was a parameter that combined death and events reflective of persistent clinical worsening of the participant's underlying diagnosis of pulmonary hypertension (PH)

Posted

Number

Percentage per 100 person-years

From baseline to End of study visit, up to 10 years and 5 months.

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Units	Counts

Other Pre-specified

Change From Baseline in Borg CR 10 Scale

The Borg CR10 Scale was measured in conjunction with the 6MWD test. The test was explained to the participant before starting the 6MWD test. Participants were asked to rank their exertion at the end of the 6MWD test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal")

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

Scores on a scale

From baseline to Week 12

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change in Score of EQ-5D Questionnaire

The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D is a self report questionnaire. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

Scores on a scale

From baseline to End of study visit, up to 10 years and 5 months.

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Other Pre-specified

Change in Score of Living With Pulmonary Hypertension (LPH) Questionnaire

The LPH questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH is a self-report questionnaire and was completed by the participant. The LPH total score can range from 0 (best) to 105 (worst).

Participants in SAF with evaluable data for each visit

Posted

Mean

Standard Deviation

Scores on a scale

From baseline to End of study visit, up to 10 years and 5 months.

ID	Title	Description
OG000	Riociguat-Former Riociguat 1.0-2.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 2.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.
OG001	Riociguat-Former Placebo	Participants were from the former placebo group of PATENT-1. The starting dose in PATENT-2 was 1.0 mg riociguat three times one day.
OG002	Riociguat-Former Riociguat 1.0-1.5 mg	Participants from the former riociguat (BAY 63-2521) 1.0 - 1.5 mg treatment group in PATENT-1 on the same dose as they received on the last day of PATENT-1.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Former Riociguat 1.0- 2.5 mg	Patients from the PATENT-1 1.0 - 2.5 mg Dose Arm will enter the extension trial (PATENT-2)with the same dose which they have received on the last day of PATENT-1 (Visit 6).	48	231	161	231	218	231
EG001	Former Riociguat 1.0 - 1.5 mg	Patients from the PATENT-1 1.0 - 1.5 mg Dose Arm will enter the extension trial (PATENT-2)with the same dose which they have received on the last day of PATENT-1 (Visit 6).	7	56	39	56	54	56
EG002	Former Placebo	Patients from the PATENT-1 Placebo Arm will enter the extension trial (PATENT-2)with the starting dose 1 mg Riociguat tid.	30	109	76	109	106	109

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events5 affected231 at risk EG0011 events1 affected56 at risk EG0027 events6 affected109 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Angina pectoris	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Arrhythmia	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0012 events2 affected56 at risk EG0022 events2 affected109 at risk
Atrial flutter	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events5 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Atrioventricular block	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cardiac failure	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG00013 events8 affected231 at risk EG0013 events1 affected56 at risk EG0028 events7 affected109 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cor pulmonale	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cor pulmonale chronic	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Palpitations	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pericardial effusion	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Right ventricular failure	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG00047 events26 affected231 at risk EG0019 events7 affected56 at risk EG0028 events6 affected109 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Tachycardia	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Cardiac dysfunction	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0022 events1 affected109 at risk
Heart disease congenital	Congenital, familial and genetic disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cataract	Eye disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0012 events1 affected56 at risk EG0020 events0 affected109 at risk
Retinal haemorrhage	Eye disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Choroidal neovascularisation	Eye disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Optic nerve disorder	Eye disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Ascites	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events1 affected231 at risk EG0011 events1 affected56 at risk EG0022 events1 affected109 at risk
Colitis	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Gastritis	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Ileus	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Melaena	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Toothache	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events2 affected231 at risk EG0010 events0 affected56 at risk EG0023 events3 affected109 at risk
Vomiting	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Subileus	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Asthenia	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Chest pain	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0022 events2 affected109 at risk
Death	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0023 events3 affected109 at risk
Injection site pain	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Malaise	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Oedema	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Oedema peripheral	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0023 events2 affected109 at risk
Sudden death	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Sudden cardiac death	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
General physical health deterioration	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Exercise tolerance decreased	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Drug intolerance	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Vascular stent stenosis	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Hepatic congestion	Hepatobiliary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Abscess	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0012 events1 affected56 at risk EG0020 events0 affected109 at risk
Acute sinusitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Appendicitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Bronchitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0005 events5 affected231 at risk EG0013 events2 affected56 at risk EG0024 events2 affected109 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cellulitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0013 events1 affected56 at risk EG0020 events0 affected109 at risk
Cervicitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Endometritis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Erysipelas	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0024 events3 affected109 at risk
Gastroenteritis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0007 events7 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Herpes zoster	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
Infected skin ulcer	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0012 events2 affected56 at risk EG0020 events0 affected109 at risk
Localised infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0012 events1 affected56 at risk EG0020 events0 affected109 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0012 events2 affected56 at risk EG0021 events1 affected109 at risk
Periodontitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pneumonia	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0004 events4 affected231 at risk EG0017 events6 affected56 at risk EG0029 events7 affected109 at risk
Pneumonia viral	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Pyelonephritis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Salmonellosis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Sepsis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0005 events4 affected231 at risk EG0012 events2 affected56 at risk EG0021 events1 affected109 at risk
Tonsillitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Tracheobronchitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Urinary tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Viral infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Urosepsis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Anal abscess	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0012 events1 affected56 at risk EG0020 events0 affected109 at risk
Appendiceal abscess	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Campylobacter infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Ureteritis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Haematoma infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Gastric infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Lung infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0013 events3 affected56 at risk EG0022 events2 affected109 at risk
Serratia infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Bronchitis bacterial	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Respiratory tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Bacterial colitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Systemic infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Vascular device infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0024 events2 affected109 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0013 events1 affected56 at risk EG0020 events0 affected109 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Snake bite	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Postoperative hypotension	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0012 events1 affected56 at risk EG0020 events0 affected109 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Biopsy	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Catheterisation cardiac	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG00024 events18 affected231 at risk EG0013 events3 affected56 at risk EG0024 events4 affected109 at risk
Chest X-ray abnormal	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Endoscopy	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0012 events2 affected56 at risk EG0020 events0 affected109 at risk
Endoscopy upper gastrointestinal tract	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Haemoglobin decreased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Intraocular pressure increased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Oxygen saturation decreased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Transplant evaluation	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Troponin increased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events2 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Gout	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Fracture delayed union	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events3 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events3 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Connective tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Systemic scleroderma	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Lymphatic system neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0003 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Cerebral infarction	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Coma hepatic	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Dizziness	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Epilepsy	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Facial paralysis	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Headache	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Presyncope	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Seizure	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Somnolence	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Syncope	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG00043 events26 affected231 at risk EG0015 events5 affected56 at risk EG00223 events15 affected109 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
Brain stem syndrome	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Central nervous system vasculitis	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Anxiety	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Completed suicide	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Delirium	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Depression	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Mental status changes	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Haematuria	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Proteinuria	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Renal colic	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Renal failure	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events4 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Renal impairment	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0012 events1 affected56 at risk EG0020 events0 affected109 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Endometrial dysplasia	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Diaphragm muscle weakness	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00012 events11 affected231 at risk EG0011 events1 affected56 at risk EG0022 events2 affected109 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00012 events8 affected231 at risk EG0012 events2 affected56 at risk EG0025 events4 affected109 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0011 events1 affected56 at risk EG0021 events1 affected109 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events3 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00021 events17 affected231 at risk EG0018 events6 affected56 at risk EG0028 events6 affected109 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pulmonary veno-occlusive disease	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0022 events2 affected109 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Nasal cavity mass	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00050 events31 affected231 at risk EG00113 events11 affected56 at risk EG00228 events14 affected109 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Hypersensitivity pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Fixed eruption	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Homicide	Social circumstances	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Abortion induced	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Atrial septal defect repair	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Gastric polypectomy	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Hysterectomy	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Lung transplant	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Osteotomy	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Prophylaxis	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Central venous catheterisation	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0021 events1 affected109 at risk
Swan ganz catheter placement	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0003 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Dental operation	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Varicose vein operation	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0010 events0 affected56 at risk EG0022 events1 affected109 at risk
Bladder polypectomy	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Cataract operation	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0002 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Balloon atrial septostomy	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0002 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Trapeziectomy	Surgical and medical procedures	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Circulatory collapse	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Haematoma	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Hypertensive crisis	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Hypotension	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events5 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Shock	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Vasculitis	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Lymphocele	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk
Device dislocation	Product Issues	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected231 at risk EG0011 events1 affected56 at risk EG0020 events0 affected109 at risk
Lead dislodgement	Product Issues	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0010 events0 affected56 at risk EG0020 events0 affected109 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG00035 events30 affected231 at risk EG0016 events6 affected56 at risk EG00229 events14 affected109 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected231 at risk EG0013 events3 affected56 at risk EG0023 events3 affected109 at risk
Cardiac failure	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0006 events6 affected231 at risk EG0014 events4 affected56 at risk EG0022 events2 affected109 at risk
Palpitations	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG00027 events22 affected231 at risk EG0019 events5 affected56 at risk EG00214 events14 affected109 at risk
Right ventricular failure	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG00010 events7 affected231 at risk EG0013 events3 affected56 at risk EG0026 events6 affected109 at risk
Tachycardia	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG00010 events9 affected231 at risk EG0017 events4 affected56 at risk EG0026 events4 affected109 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (22.0)	Non-systematic Assessment	EG0006 events6 affected231 at risk EG0011 events1 affected56 at risk EG0027 events6 affected109 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00020 events14 affected231 at risk EG0010 events0 affected56 at risk EG0027 events6 affected109 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00024 events17 affected231 at risk EG0014 events4 affected56 at risk EG00211 events9 affected109 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00019 events18 affected231 at risk EG0012 events2 affected56 at risk EG0028 events7 affected109 at risk
Constipation	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00026 events22 affected231 at risk EG0012 events2 affected56 at risk EG00211 events10 affected109 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00081 events50 affected231 at risk EG00122 events11 affected56 at risk EG00262 events34 affected109 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00068 events34 affected231 at risk EG0019 events8 affected56 at risk EG00222 events14 affected109 at risk
Gastritis	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0008 events7 affected231 at risk EG0013 events3 affected56 at risk EG00212 events10 affected109 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00019 events16 affected231 at risk EG0016 events6 affected56 at risk EG00216 events13 affected109 at risk
Nausea	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00063 events46 affected231 at risk EG00110 events8 affected56 at risk EG00241 events26 affected109 at risk
Vomiting	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00047 events36 affected231 at risk EG00119 events9 affected56 at risk EG00234 events23 affected109 at risk
Asthenia	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG00023 events17 affected231 at risk EG0014 events3 affected56 at risk EG0028 events6 affected109 at risk
Chest discomfort	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG00026 events15 affected231 at risk EG0017 events6 affected56 at risk EG0026 events6 affected109 at risk
Chest pain	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG00044 events32 affected231 at risk EG0017 events7 affected56 at risk EG00225 events16 affected109 at risk
Fatigue	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG00023 events20 affected231 at risk EG0016 events4 affected56 at risk EG00220 events12 affected109 at risk
Oedema	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG00011 events9 affected231 at risk EG0016 events4 affected56 at risk EG00211 events9 affected109 at risk
Oedema peripheral	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG000108 events64 affected231 at risk EG00126 events17 affected56 at risk EG00251 events31 affected109 at risk
Pyrexia	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG00045 events24 affected231 at risk EG0013 events3 affected56 at risk EG0028 events7 affected109 at risk
Peripheral swelling	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0007 events7 affected231 at risk EG0017 events5 affected56 at risk EG0025 events4 affected109 at risk
Bronchitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00035 events24 affected231 at risk EG00113 events11 affected56 at risk EG00219 events14 affected109 at risk
Conjunctivitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00010 events8 affected231 at risk EG0015 events3 affected56 at risk EG0024 events4 affected109 at risk
Gastroenteritis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00015 events14 affected231 at risk EG0016 events6 affected56 at risk EG0027 events6 affected109 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00011 events9 affected231 at risk EG0015 events3 affected56 at risk EG0023 events3 affected109 at risk
Influenza	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00021 events14 affected231 at risk EG0017 events7 affected56 at risk EG0025 events4 affected109 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00011 events8 affected231 at risk EG0015 events3 affected56 at risk EG00217 events6 affected109 at risk
Nasopharyngitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG000160 events76 affected231 at risk EG00144 events21 affected56 at risk EG00281 events31 affected109 at risk
Oral candidiasis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0013 events3 affected56 at risk EG0020 events0 affected109 at risk
Pharyngitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00013 events9 affected231 at risk EG0018 events4 affected56 at risk EG0024 events4 affected109 at risk
Pneumonia	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0009 events9 affected231 at risk EG0017 events7 affected56 at risk EG00210 events8 affected109 at risk
Sinusitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00025 events13 affected231 at risk EG0011 events1 affected56 at risk EG00211 events9 affected109 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00064 events39 affected231 at risk EG00120 events10 affected56 at risk EG00249 events24 affected109 at risk
Urinary tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00021 events12 affected231 at risk EG00112 events9 affected56 at risk EG00217 events12 affected109 at risk
Lung infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0005 events4 affected231 at risk EG0014 events3 affected56 at risk EG0024 events4 affected109 at risk
Respiratory tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG00053 events24 affected231 at risk EG00110 events5 affected56 at risk EG00219 events13 affected109 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG00013 events12 affected231 at risk EG0011 events1 affected56 at risk EG0023 events2 affected109 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG00024 events17 affected231 at risk EG0011 events1 affected56 at risk EG0024 events3 affected109 at risk
Blood potassium decreased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG00010 events8 affected231 at risk EG0013 events3 affected56 at risk EG0026 events4 affected109 at risk
International normalised ratio increased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG00011 events9 affected231 at risk EG0015 events4 affected56 at risk EG0024 events4 affected109 at risk
Weight decreased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0009 events8 affected231 at risk EG0010 events0 affected56 at risk EG0027 events6 affected109 at risk
Weight increased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0008 events6 affected231 at risk EG0017 events5 affected56 at risk EG0021 events1 affected109 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG00034 events26 affected231 at risk EG00114 events9 affected56 at risk EG00216 events12 affected109 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG00013 events11 affected231 at risk EG0014 events4 affected56 at risk EG0029 events7 affected109 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00034 events28 affected231 at risk EG0017 events6 affected56 at risk EG00215 events10 affected109 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected231 at risk EG0015 events4 affected56 at risk EG0024 events3 affected109 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00048 events36 affected231 at risk EG0017 events5 affected56 at risk EG00217 events11 affected109 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events4 affected231 at risk EG0014 events3 affected56 at risk EG0022 events2 affected109 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0008 events6 affected231 at risk EG0014 events3 affected56 at risk EG00211 events9 affected109 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00016 events10 affected231 at risk EG0014 events4 affected56 at risk EG0026 events6 affected109 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0006 events5 affected231 at risk EG0014 events4 affected56 at risk EG00210 events7 affected109 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00035 events27 affected231 at risk EG0017 events7 affected56 at risk EG00215 events12 affected109 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events4 affected231 at risk EG0014 events4 affected56 at risk EG0020 events0 affected109 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events5 affected231 at risk EG0013 events3 affected56 at risk EG0021 events1 affected109 at risk
Dizziness	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG000118 events67 affected231 at risk EG00122 events15 affected56 at risk EG00257 events31 affected109 at risk
Headache	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG000102 events46 affected231 at risk EG00114 events10 affected56 at risk EG00261 events34 affected109 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0009 events9 affected231 at risk EG0014 events4 affected56 at risk EG0023 events3 affected109 at risk
Presyncope	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events5 affected231 at risk EG0014 events2 affected56 at risk EG0029 events8 affected109 at risk
Anxiety	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG00010 events10 affected231 at risk EG0011 events1 affected56 at risk EG00214 events8 affected109 at risk
Depression	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG00013 events13 affected231 at risk EG0015 events3 affected56 at risk EG0027 events6 affected109 at risk
Insomnia	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG00024 events21 affected231 at risk EG0015 events5 affected56 at risk EG00213 events10 affected109 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00094 events66 affected231 at risk EG00120 events13 affected56 at risk EG00242 events28 affected109 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00054 events33 affected231 at risk EG00115 events12 affected56 at risk EG00221 events15 affected109 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00042 events30 affected231 at risk EG00118 events12 affected56 at risk EG00220 events16 affected109 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00046 events20 affected231 at risk EG0016 events2 affected56 at risk EG00210 events9 affected109 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0009 events8 affected231 at risk EG0014 events3 affected56 at risk EG0027 events6 affected109 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00016 events12 affected231 at risk EG0012 events2 affected56 at risk EG00210 events8 affected109 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0008 events6 affected231 at risk EG0014 events3 affected56 at risk EG0026 events4 affected109 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00020 events15 affected231 at risk EG0012 events2 affected56 at risk EG00220 events13 affected109 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events5 affected231 at risk EG0013 events3 affected56 at risk EG0024 events3 affected109 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected231 at risk EG0014 events4 affected56 at risk EG0020 events0 affected109 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events4 affected231 at risk EG0015 events4 affected56 at risk EG0021 events1 affected109 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00016 events10 affected231 at risk EG0013 events3 affected56 at risk EG0023 events3 affected109 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00018 events13 affected231 at risk EG0013 events3 affected56 at risk EG0024 events3 affected109 at risk
Haematoma	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0008 events7 affected231 at risk EG0013 events3 affected56 at risk EG0022 events2 affected109 at risk
Hypotension	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG00039 events32 affected231 at risk EG00113 events10 affected56 at risk EG00214 events10 affected109 at risk

ID	Term
D006976	Hypertension, Pulmonary
D000081029	Pulmonary Arterial Hypertension

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases