Study to Investigate the Safety of a Drug Called Osocimab... | NCT04523220

NCT04523220

ID	Type	Description	Link
2019-003957-27	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BAY1213790 low dose	Experimental	Participants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period.	Drug: BAY1213790 (Osocimab)
Placebo low dose	Placebo Comparator	Placebo will be administered subcutaneously in the same manner as Osocimab.	Drug: Placebo
BAY1213790 high dose	Experimental	Participants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period.	Drug: BAY1213790 (Osocimab)
Placebo high dose	Experimental	Placebo will be administered subcutaneously in the same manner as Osocimab.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BAY1213790 (Osocimab)	Drug	Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.	BAY1213790 high dose BAY1213790 low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)	Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events [in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.	From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)	Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.	From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.	The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). aPTT was measured via the kaolin-trigger method (clotting assay).	At 6 months (Visit 19 / Day 30 of the 6th month)

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
North America Research Institute - Azusa		Azusa	California	91702	United States
Fresenius Kidney Care - Brawley

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38365952	Derived	Weitz JI, Tanko LB, Floege J, Fox KAA, Bhatt DL, Thadhani R, Hung J, Pap AF, Kubitza D, Winkelmayer WC; CONVERT Investigators. Anticoagulation with osocimab in patients with kidney failure undergoing hemodialysis: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):435-442. doi: 10.1038/s41591-023-02794-7. Epub 2024 Feb 16.

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	Higher-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.

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	Mar 16, 2020	May 5, 2023

Arm/Group Information

ID	Title	Description
BG000	Higher-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
BG001	Lower-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
BG002	Placebo	Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.
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, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000234 ParticipantsBG001235 ParticipantsBG002235 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000234 ParticipantsBG001235 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000234 ParticipantsBG001235 ParticipantsBG002

Activated partial thromboplastin time (aPTT) value at baseline

aPTT was measured via the kaolin-trigger method (clotting assay). Furthermore, the aPTT assay was conducted after in vitro- neutralization of heparin in order to separate potential heparin effects from the PD effect of osocimab.

Participants in PDS with evaluable assessment for this measurement.

Geometric Mean

Standard Deviation

seconds

Title	Denominators	Categories
	ParticipantsBG000209 ParticipantsBG001213 Participants

Factor XI (FXI) activity at baseline

Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma. Furthermore, the assay was conducted after in vitro-neutralization of heparin in order to separate potential heparin effects from the PD effect of osocimab.

Participants in PDS with evaluable assessment for this measurement.

Geometric Mean

Standard Deviation

percent

Title	Denominators	Categories
	ParticipantsBG000208 ParticipantsBG001212 Participants

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

Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)

Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table.

Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis.

Descriptive time to composite of treatment emergent major and CRNMB events [in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.

SAF (Safety analysis set): All participants randomly assigned to study intervention who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.

Posted

Number

90% Confidence Interval

Percentage of participants

From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months

ID	Title	Description
OG000	Higher-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
OG001	Lower-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
OG002	Placebo	Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.

Units	Counts
Participants	OG000224 OG001232 OG002230

Title

Denominators

Categories

Title	Measurements
	OG0003.57(1.91 to 6.04) OG0014.32(2.48 to 6.91) OG0026.09(3.84 to 9.04)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.	Log Rank		= 0.222	Due to the explorative nature of these analyses, no multiplicity adjustment was done.	Cox Proportional Hazard	0.59			2-Sided	90	0.28	1.21					Other
OG001 OG002

Primary

Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)

Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table.

Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis.

An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.

SAF (Safety analysis set)

Posted

Number

90% Confidence Interval

Percentage of participants

From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months

ID	Title	Description
OG000	Higher-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
OG001	Lower-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.

Secondary

Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.

The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).

aPTT was measured via the kaolin-trigger method (clotting assay).

PDS (Pharmacodynamic analysis set): All participants with at least 1 PD sample in accordance with the PD sampling schedule and without deviation from the protocol that would have interfered with the evaluation of the PD data were included in the PD analysis. Participants in PDS with data available for this outcome measure

Posted

Geometric Mean

Standard Deviation

Ratio

At 6 months (Visit 19 / Day 30 of the 6th month)

ID	Title	Description
OG000	Higher-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
OG001	Lower-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.

Secondary

Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline

The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).

Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.

PDS (Pharmacodynamic analysis set). Participants in PDS with data available for this outcome measure

Posted

Geometric Mean

Standard Deviation

Ratio

At 6 months (Visit 19 / Day 30 of the 6th month)

ID	Title	Description
OG000	Higher-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.
OG001	Lower-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.

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	Higher-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.	19	224	61	224	90	224
EG001	Lower-dose Osocimab	Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase. Participants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.	24	232	67	232	85	232
EG002	Placebo	Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.	15	230	63	230	88	230

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected232 at risk EG0022 events2 affected230 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected232 at risk EG0022 events2 affected230 at risk
Angina pectoris	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Angina unstable	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Bradycardia	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Cardiac arrest	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Cardiac failure	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected232 at risk EG0020 events0 affected230 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Dressler's syndrome	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Myocardial infarction	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0023 events3 affected230 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0003 events2 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Mitral valve disease	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Cataract	Eye disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0022 events2 affected230 at risk
Diabetic retinopathy	Eye disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Retinal detachment	Eye disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Enteritis	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Ileus	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Tongue haematoma	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Gastrointestinal wall thickening	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Asthenia	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Chest pain	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected232 at risk EG0021 events1 affected230 at risk
Sudden death	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
General physical health deterioration	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Cardiac death	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Bacteraemia	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Cellulitis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected232 at risk EG0021 events1 affected230 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Gangrene	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Localised infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Osteomyelitis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Peritonitis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Pneumonia	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0010 events0 affected232 at risk EG0024 events4 affected230 at risk
Pneumonia viral	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Postoperative wound infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Sepsis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected232 at risk EG0022 events2 affected230 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Urinary tract infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Urosepsis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Abscess limb	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Coronavirus infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected232 at risk EG0022 events2 affected230 at risk
Febrile infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0002 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Perirectal abscess	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Renal cyst infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Diabetic foot infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Device related infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Vascular access site infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
COVID-19	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0007 events7 affected224 at risk EG0018 events8 affected232 at risk EG0025 events5 affected230 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0019 events9 affected232 at risk EG0028 events8 affected230 at risk
Device related bacteraemia	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0002 events1 affected224 at risk EG0011 events1 affected232 at risk EG0023 events3 affected230 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0022 events1 affected230 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events1 affected232 at risk EG0020 events0 affected230 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Shunt aneurysm	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0021 events1 affected230 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0002 events1 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Unintentional medical device removal	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Vascular access site inflammation	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Angiocardiogram	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected232 at risk EG0021 events1 affected230 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected232 at risk EG0020 events0 affected230 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Syncope	Nervous system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0021 events1 affected230 at risk
Lacunar infarction	Nervous system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0022 events1 affected230 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0022 events1 affected230 at risk
Mental status changes	Psychiatric disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Haematuria	Renal and urinary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected232 at risk EG0020 events0 affected230 at risk
Nephrosclerosis	Renal and urinary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Renal haematoma	Renal and urinary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Renal mass	Renal and urinary disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected232 at risk EG0021 events1 affected230 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Parathyroidectomy	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Renal transplant	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0013 events3 affected232 at risk EG0025 events5 affected230 at risk
Toe amputation	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Central venous catheterisation	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Intervertebral disc operation	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Dialysis device insertion	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Arteriovenous graft	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Bladder neoplasm surgery	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Peritoneal catheter insertion	Surgical and medical procedures	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Aortic dissection	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Aortic stenosis	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Hypertension	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Hypotension	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0022 events1 affected230 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Iliac artery dissection	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected232 at risk EG0020 events0 affected230 at risk
Hypertensive emergency	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events1 affected232 at risk EG0021 events1 affected230 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected232 at risk EG0021 events1 affected230 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0022 events1 affected230 at risk
Peripheral vein occlusion	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected232 at risk EG0020 events0 affected230 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Non-systematic Assessment	EG00010 events10 affected224 at risk EG00112 events12 affected232 at risk EG00213 events12 affected230 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG00016 events13 affected224 at risk EG0016 events6 affected232 at risk EG00218 events16 affected230 at risk
Vomiting	Gastrointestinal disorders	MedDRA (25.0)	Non-systematic Assessment	EG0007 events7 affected224 at risk EG00110 events8 affected232 at risk EG00216 events12 affected230 at risk
Pyrexia	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG00015 events14 affected224 at risk EG00112 events9 affected232 at risk EG00217 events14 affected230 at risk
COVID-19	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG00011 events11 affected224 at risk EG00114 events14 affected232 at risk EG00212 events12 affected230 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Non-systematic Assessment	EG00020 events12 affected224 at risk EG00117 events9 affected232 at risk EG00223 events15 affected230 at risk
Headache	Nervous system disorders	MedDRA (25.0)	Non-systematic Assessment	EG00021 events19 affected224 at risk EG00126 events23 affected232 at risk EG00215 events14 affected230 at risk
Hypertension	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG00020 events18 affected224 at risk EG00124 events18 affected232 at risk EG00217 events16 affected230 at risk
Hypotension	Vascular disorders	MedDRA (25.0)	Non-systematic Assessment	EG00022 events15 affected224 at risk EG00127 events13 affected232 at risk EG00228 events18 affected230 at risk

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms