A Safety, Pharmacokinetics and Efficacy Study of MAU868 f... | NCT04294472

NCT04294472

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
Cohort 1	Experimental	Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses	Drug: MAU868
Cohort 2	Experimental	Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses	Drug: MAU868
Cohort 3	Experimental	Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses	Drug: MAU868
Placebo Cohort 1, 2, 3	Placebo Comparator	5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MAU868	Drug	MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log	The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.	Study Week 1 - Study Week 36
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)	The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.	Study Week 1 - Study Week 36

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-0111	United States
Cedars-Sinai Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39382091	Derived	Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
39352862	Derived	Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo: 5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
FG001	Active Arm (Cohort 1)	MAU868 1350 mg every 28 days for a total of 4 doses

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	Apr 15, 2020	Feb 9, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. Overall Number of Baseline Participants was based on 28 randomized and treated participants.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo: 5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
BG001	Active Arm (Cohort 1)	MAU868 1350 mg every 28 days for a total of 4 doses
BG002	Active Arm (Cohort 2)	MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0008 BG00110 BG00210 BG00328

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
	BG00052.5± 16.85 BG00160.1± 13.52 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG0000 BG0011 BG002

eGFR (CK-EPI)(mL/min/ 1.73m^2)

Mean

Standard Deviation

mL/min/ 1.73m^2

Title

Denominators

Categories

Title	Measurements
	BG00059.5± 21.23 BG00154.1± 22.93 BG002

Time from Kidney Transplant (days)

Mean

Standard Deviation

Days

Title

Denominators

Categories

Title	Measurements
	BG000174.6± 82.57 BG001175.6± 93.53 BG002

Baseline Plasma Viral Load (copies/mL) based on central lab

Mean

Standard Deviation

copies/mL

Title

Denominators

Categories

Title	Measurements
	BG000315100.0± 620601.58 BG00185100.0± 152159.91 BG002

Duration of BK Viremia (days)

Mean

Standard Deviation

Days

Title

Denominators

Categories

Title	Measurements
	BG00058.4± 23.11 BG00156.6± 39.33 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

Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log

The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.

Posted

Mean

Standard Deviation

Weeks

Study Week 1 - Study Week 36

ID	Title	Description
OG000	Placebo	Placebo: 5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
OG001	Active Arm (Cohort 1)	MAU868 1350 mg every 28 days for a total of 4 doses
OG002	Active Arm (Cohort 2)	MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses

Units	Counts
Participants	OG0008 OG00110 OG00210

Title

Denominators

Categories

Title	Measurements
	OG00019.61± 11.75 OG00110.80± 11.50 OG00218.25± 16.28

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 OG001		Log Rank		0.1866														Superiority	Cohort 1 vs Placebo
OG000 OG002		Log Rank		0.2627

Primary

Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)

The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.

Posted

Mean

Standard Deviation

Weeks

Study Week 1 - Study Week 36

ID	Title	Description
OG000	Placebo	Placebo: 5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
OG001	Active Arm (Cohort 1)	MAU868 1350 mg every 28 days for a total of 4 doses
OG002	Active Arm (Cohort 2)	MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses

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	Placebo	Placebo: 5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses	0	8	2	8	8	8
EG001	Active Arm (Cohort 1)	MAU868 1350 mg every 28 days for a total of 4 doses	1	10	6	10	9	10
EG002	Active Arm (Cohort 2)	MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses	1	10	6	10	9	10

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bone marrow failure	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Hernia	General disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Transplant rejection	Immune system disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Corona virus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected10 at risk
Oesophageal candidiasis	Infections and infestations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Pneumonia viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0022 events1 affected10 at risk
Postoperative wound infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Renal graft infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Urosepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected10 at risk EG0021 events1 affected10 at risk
Incision site haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Transaminases increased	Investigations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected10 at risk EG0021 events1 affected10 at risk
Hypercalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected10 at risk EG0020 events0 affected10 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected8 at risk EG0012 events1 affected10 at risk EG0020 events0 affected10 at risk
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Supraventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Melaena	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected10 at risk EG0020 events0 affected10 at risk
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Cyst	General disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Fatigue	General disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Infusion site extravasation	General disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Injection site swelling	General disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Pain	General disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Pyrexia	General disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Chronic allograft nephropathy	Immune system disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Kidney transplant rejection	Immune system disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Transplant rejection	Immune system disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Aspergillus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
BK virus infection	Infections and infestations	Systematic Assessment	EG0003 events2 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Cellulitis of male external genital organ	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Clostridium difficile infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Cytomegalovirus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Cytomegalovirus viraemia	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected10 at risk
Eye infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Helicobacter infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Herpes zoster	Infections and infestations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Prostate infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Tooth infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected10 at risk EG0020 events0 affected10 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected8 at risk EG0013 events2 affected10 at risk EG0021 events1 affected10 at risk
Urinary tract infection bacterial	Infections and infestations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Concussion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Post procedural swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Tooth fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Vascular access complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0025 events1 affected10 at risk
Wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Wrist fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Blood bicarbonate decreased	Investigations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Blood creatine phosphokinase increased	Investigations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Blood creatinine increased	Investigations	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0023 events3 affected10 at risk
Gamma-glutamyltransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Hepatic enzyme increased	Investigations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Vitamin D decreased	Investigations	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected10 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Metabolic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected10 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events1 affected10 at risk EG0020 events0 affected10 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0022 events1 affected10 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events2 affected10 at risk EG0020 events0 affected10 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected10 at risk
Chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Hydronephrosis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Microalbuminuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Prostatic obstruction	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected10 at risk EG0020 events0 affected10 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0003 events3 affected8 at risk EG0011 events1 affected10 at risk EG0023 events1 affected10 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk

First MCP Posted Date

BG003129239.3± 350731.32