Vascular Endothelial Growth Factor-B (VEGF-B) Blockade Wi... | NCT04419467

NCT04419467

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
CSL346 (low dose)	Experimental	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions	Biological: CSL346
CSL346 (high dose)	Experimental	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions	Biological: CSL346
Placebo	Placebo Comparator	Administered as a single IV loading dose followed by SC infusions	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CSL346	Biological	VEGF-B antagonist monoclonal antibody	CSL346 (high dose) CSL346 (low dose)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)	Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.	Baseline up to Week 16

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)		Up to 24 weeks
Percentage of Subjects With TEAEs		Up to 24 weeks
Number of Subjects With Adverse Events of Special Interest (AESIs)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Study Director	CSL Behring	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
California Kidney Specialists (CKS) - Citrus Office		Covina	California	91702	United States
Valley Research - Fresno

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39150859	Derived	Cooper M, Cherney DZI, Greene TH, Heerspink HJL, Jardine M, Lewis JB, Wong MG, Baquero E, Heise M, Jochems J, Lanchoney D, Liss C, Reiser D, Scotney P, Velkoska E, Dwyer JP. Vascular Endothelial Growth Factor-B Blockade with CSL346 in Diabetic Kidney Disease: A Phase 2A Randomized Controlled Trial. J Am Soc Nephrol. 2024 Nov 1;35(11):1546-1557. doi: 10.1681/ASN.0000000000000438. Epub 2024 Aug 16.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
FG001	CSL346 (High Dose)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 27, 2021	Oct 24, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions

CSL346: VEGF-B antagonist monoclonal antibody

Intent-to-Treat Analysis Set

Arm/Group Information

ID	Title	Description
BG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
BG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
BG002	Placebo	Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline
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

Median

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	BG00062.0(37 to 78) BG00161.0(39 to 84) BG00263.0(32 to 85) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG0017 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0008 BG0019 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

New Zealand

Title	Measurements
	BG0008 BG0015 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

Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)

Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.

Intent to Treat Analysis Set

Posted

Geometric Mean

80% Confidence Interval

Geometric Mean of Percent Change

Baseline up to Week 16

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG002	Placebo	Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline

Units	Counts
Participants	OG00028 OG00127 OG00248

Title

Denominators

Categories

Title	Measurements
	OG0003.2(-9.79 to 18.05) OG00117.7(2.54 to 35.18) OG0025.4(-3.24 to 14.91)

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		Mixed Models Repeated Measures Analysis		0.485	One-sided p-value	GM % treatment difference (80% CI)	-0.5			2-Sided	80	-14.8	16.3			Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean (GM), then expressed as percent treatment difference.		Superiority

Secondary

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

Safety Analysis Set

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG002	Placebo	Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With TEAEs

Safety Analysis Set

Posted

Number

Percentage of participants

Up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG002	Placebo	Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Adverse Events of Special Interest (AESIs)

Data are presented for treatment-emergent AESIs.

Safety Analysis Set

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG002	Placebo	Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline

Units	Counts
Participants

Secondary

Percentage of Subjects With AESIs

Data are presented for treatment-emergent AESIs.

Safety Analysis Set

Posted

Number

Percentage of participants

Up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody
OG002	Placebo	Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline

Units	Counts
Participants	OG000

Secondary

Observed Value and Mean Change From Baseline in Serum Creatinine

Intent-to-Treat Analysis Set

Posted

Mean

Standard Deviation

mg/dL

Baseline up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG001	CSL346 (Low Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.
OG002	CSL346 (High Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG003	CSL346 (High Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.

Secondary

Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Intent-to-Treat Analysis Set

Posted

Mean

Standard Deviation

mL/min/1.73 m^2

Baseline up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG001	CSL346 (Low Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.
OG002	CSL346 (High Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG003	CSL346 (High Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.

Secondary

Observed Value and Mean Change From Baseline in Systolic Blood Pressure

Intent-to-Treat Analysis Set

Posted

Mean

Standard Deviation

mmHg

Baseline up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG001	CSL346 (Low Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.
OG002	CSL346 (High Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG003	CSL346 (High Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.

Secondary

Observed Value and Mean Change From Baseline in Diastolic Blood Pressure

Intent-to-Treat Analysis Set

Posted

Mean

Standard Deviation

mmHg

Baseline up to 24 weeks

ID	Title	Description
OG000	CSL346 (Low Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG001	CSL346 (Low Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.
OG002	CSL346 (High Dose) - Observed	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Observed value.
OG003	CSL346 (High Dose) - Change	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.

Secondary

Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples

Pharmacokinetic (PK) Analysis Set

Posted

Mean

Standard Deviation

ug/mL

Up to 120 minutes after the IV loading dose for CSL346

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

Secondary

Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples

PK Analysis Set

Posted

Median

Full Range

Hours

Up to 120 minutes after the IV loading dose for CSL346

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

Secondary

Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples

PK Analysis Set

Posted

Mean

Standard Deviation

ug/mL

From Day 1 to Day 29

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

Secondary

Tmax After First SC Dose of CSL346 in Serum Samples

PK Analysis Set

Posted

Median

Full Range

Hours

From Day 1 to Day 29

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration-time Curve in First Dosing Interval

PK Analysis Set

Posted

Mean

Standard Deviation

Hours*ug/mL

From Day 1 to Day 29

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

Secondary

Trough Concentration After Each Dose

PK Analysis Set

Posted

Mean

Standard Deviation

ug/mL

29 days after each dose

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

Secondary

Number of Subjects Positive for Anti-drug Antibodies

Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.

Safety Analysis Set

Posted

Count of Participants

Participants

Weeks 4, 8, and 16

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Positive for Anti-drug Antibodies

Safety Analysis Set

Posted

Number

Percentage of participants

Weeks 4, 8, and 16

ID	Title	Description
OG000	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions. CSL346: VEGF-B antagonist monoclonal antibody
OG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody

Units	Counts
Participants	OG000

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	CSL346 (Low Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody	1	29	3	29	17	29
EG001	CSL346 (High Dose)	Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody	1	29	6	29	11	29
EG002	Placebo	Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline	0	54	5	54	18	54

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Campylobacter gastroenteritis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Subdural abscess	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Urinary tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Urosepsis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Paroxysmal atrioventricular block	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Vomiting	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Non-cardiac chest pain	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Brain natriuretic peptide increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Amnesia	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected54 at risk
Albuminuria	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0005 events5 affected29 at risk EG0013 events3 affected29 at risk EG0022 events2 affected54 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0022 events1 affected54 at risk
Tooth infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Blood creatinine increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0004 events3 affected29 at risk EG0011 events1 affected29 at risk EG0024 events3 affected54 at risk
C-reactive protein increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected54 at risk
Oedema peripheral	General disorders	MedDRA (25.0)	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Injection site pain	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0021 events1 affected54 at risk
Injection site swelling	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0025 events3 affected54 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0003 events3 affected29 at risk EG0013 events2 affected29 at risk EG0022 events1 affected54 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0024 events4 affected54 at risk
Albuminuria	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0005 events3 affected29 at risk EG0013 events2 affected29 at risk EG0023 events2 affected54 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected54 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0021 events1 affected54 at risk
Constipation	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk
Dizziness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected54 at risk

First MCP Posted Date

ID	Term
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases