A Study in Maintenance Kidney Transplant Recipients Follo... | NCT01820572

ID	Type	Description	Link
2012-001314-42	EudraCT Number

Status Module

Oversight 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
Belatacept	Experimental	Belatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months	Drug: Belatacept
CNI	Active Comparator	Tacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months	Drug: Tacrolimus Drug: Cyclosporine

Name	Type	Description	Arm Group Labels	Other Names
Belatacept	Drug		Belatacept	BMS 224818 Nulojix®
Tacrolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Survive With a Functional Graft at 24 Months	Percentage of participants who survive with a functional graft at 24 months post-randomization	at 24 Months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Survive With a Functional Graft at 12 Months	Percentage of participants who survive with a functional graft at 12 months post-randomization	at 12 Months
Number of Participants With a Biopsy Proven Acute Rejection (BPAR)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UAB Division of Nephrology		Birmingham	Alabama	35294	United States
Mayo Clinic Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34706967	Derived	Budde K, Prashar R, Haller H, Rial MC, Kamar N, Agarwal A, de Fijter JW, Rostaing L, Berger SP, Djamali A, Leca N, Allamassey L, Gao S, Polinsky M, Vincenti F. Conversion from Calcineurin Inhibitor- to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial. J Am Soc Nephrol. 2021 Dec 1;32(12):3252-3264. doi: 10.1681/ASN.2021050628. Epub 2021 Dec 1.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
FG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 18, 2018	Oct 22, 2020

Arm/Group Information

ID	Title	Description
BG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
BG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens
BG002	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

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00055.0± 11.3 BG00154.0± 11.7 BG00254.0± 11.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00073 BG00172 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG00115 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 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

Percentage of Participants Who Survive With a Functional Graft at 24 Months

Percentage of participants who survive with a functional graft at 24 months post-randomization

All Randomized Participants

Posted

Number

95% Confidence Interval

Percentage

at 24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000223 OG001223

Title

Denominators

Categories

Title	Measurements
	OG00098.2(95.5 to 99.5) OG00197.3(95.2 to 99.4)

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						Difference in proportions	0.9			2-Sided	95	-8.6	10.4					Superiority	difference between belatacept and CNI

Secondary

Percentage of Participants Who Survive With a Functional Graft at 12 Months

Percentage of participants who survive with a functional graft at 12 months post-randomization

All Randomized Participants

Posted

Number

95% Confidence Interval

Percentage

at 12 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Biopsy Proven Acute Rejection (BPAR)

The number of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization

includes participants with at least one cellular and/or humoral BPAR event.

All Randomized Participants

Posted

Count of Participants

Participants

at 12 and 24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Number of Participants With Varying Severity of BPAR

Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization

All Randomized Participants who had a BPAR

Posted

Count of Participants

Participants

at 12 and 24 months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change

Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change

All Randomized Participants

Posted

Mean

95% Confidence Interval

Percent Change

at 12 and 24 months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change

Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change

All Randomized Participants

Posted

Mean

95% Confidence Interval

mL/min/1.73m²

at 12 and 24 months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Mean Calculated Glomerular Filtration Rate (cGFR)

Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.

All Randomized Participants

Posted

Mean

95% Confidence Interval

mL/min/1.73m²

up to 24 months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Slope Analysis of cGFR

Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization

All Randomized Participants

Posted

Number

95% Confidence Interval

mL/min/1.73m²/month

at 12 and 24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Slope Analysis of 1/Serum Creatinine

Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization

All Randomized Participants

Posted

Number

95% Confidence Interval

mg/dL/month

at 12 and 24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR

Percentage of participants with > 5% and >10% improvement over baseline cGFR, at 12 and 24 months post-randomization

All Randomized Participants

Posted

Number

Percentage

at 12 and 24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Mean Urine Protein/ Creatinine Ratio (UPCR)

Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization

All Randomized Participants

Posted

Mean

95% Confidence Interval

mg/mmol

Up to 24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Systolic and Diastolic Blood Pressure

Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization

All Randomized Participants

Posted

Mean

90% Confidence Interval

mmHg

at 12 and 24 months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Number of Antihypertensive Medications Used to Control Hypertension

The total number of antihypertensive medications used to control hypertension

All Randomized Participants

Posted

Mean

Full Range

Number of medications

at baseline, 12 and 24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Number of Participants With Donor Specific Antibodies (DSA)

Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization

All Randomized Participants

Posted

Count of Participants

Participants

at baseline, 12 and 24 months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Mean Number of Symptom Occurrence and Symptom Distress

The frequency of symptom occurrence and symptom distress as measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSD-59R) at baseline, Week 6, and Months 3, 6, and 12 post-randomization.

Higher scores in the MTSOSD-59R indicate a greater symptom and symptom distress burden than lower scores.

All randomized and Treated Participants

Posted

Mean

Standard Deviation

Scores on a scale

up to 12 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Adverse Event of Special Interest

Number of participants with an adverse event of special interests. Adverse events of special interest include:

Serious Infections, Post-Transplant Lymphoproliferative Disorder (PTLD), Progressive multifocal leukoencephalopathy (PML), Malignancies (other than PTLD) including non-melanoma skin carcinomas, Tuberculosis Infections, CNS infections, Viral Infections and Infusion related reactions.

As Treated Population

Posted

Number

participants

24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Number of Participants With Marked Laboratory Abnormalities

Number of participants with Marked Laboratory Abnormalities

All Randomized and Treated Participants

Posted

Number

Participants

24 Months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Vital Signs: Heart Rate

The mean change from baseline in measured heart rate

All Randomized and Treated Participants

Posted

Mean

95% Confidence Interval

beats per minute (bpm)

at 12 and 24 months

ID	Title	Description
OG000	Belatacept	Participants who converted to belatacept treatment from CNI-Based
OG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens

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	Belatacept	Participants who converted to belatacept treatment from CNI-Based	4	221	107	221	174	221
EG001	CNI-Based Regimen	Participants who continued on CNI-Based regimens	5	222	95	222	168	222

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Monocytosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0011 affected222 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Angina unstable	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0011 affected222 at risk
Cardiac arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0013 affected222 at risk
Coronary artery disease	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0011 affected222 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0012 affected222 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Palpitations	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected221 at risk EG0010 affected222 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Angle closure glaucoma	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Retinal vein occlusion	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Dental caries	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0016 affected222 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0012 affected222 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Chronic fatigue syndrome	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Impaired healing	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Pneumatosis	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Sudden cardiac death	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Sudden death	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Chronic allograft nephropathy	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0012 affected222 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG00019 affected221 at risk EG0017 affected222 at risk
Renal transplant failure	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Anal abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
BK virus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0012 affected222 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected221 at risk EG0010 affected222 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0013 affected222 at risk
Chronic sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0012 affected222 at risk
Diverticulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Erysipelas	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Escherichia infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Escherichia sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Gangrene	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0016 affected222 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Hepatic cyst infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Herpes zoster	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Histoplasmosis disseminated	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Infected cyst	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Infected lymphocele	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0012 affected222 at risk
Localised infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Lung infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Necrotising soft tissue infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Oral candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Osteomyelitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected221 at risk EG0017 affected222 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Post procedural infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Pyelonephritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Renal cyst infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0012 affected222 at risk
Renal graft infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0011 affected222 at risk
Sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 affected221 at risk EG0012 affected222 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Systemic candida	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0007 affected221 at risk EG0017 affected222 at risk
Urosepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0006 affected221 at risk EG0013 affected222 at risk
Wound infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0012 affected222 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0012 affected222 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Shunt blood flow excessive	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0012 affected222 at risk
Donor specific antibody present	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Norovirus test positive	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0013 affected222 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0012 affected222 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG00011 affected221 at risk EG0015 affected222 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0003 affected221 at risk EG0015 affected222 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0004 affected221 at risk EG0011 affected222 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Cerebral artery stenosis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Hemiparesis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Loss of consciousness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0013 affected222 at risk
Confusional state	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Depressive delusion	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Suicide attempt	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected221 at risk EG0015 affected222 at risk
Bladder diverticulum	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Proteinuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Renal disorder	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Renal impairment	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Vesicoureteric reflux	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Vulvar dysplasia	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0012 affected222 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0011 affected222 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0011 affected222 at risk
Dry gangrene	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk
Extremity necrosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Haematoma	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected221 at risk EG0010 affected222 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0012 affected222 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected221 at risk EG0010 affected222 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected221 at risk EG0011 affected222 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00012 affected221 at risk EG00113 affected222 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00047 affected221 at risk EG00161 affected222 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00015 affected221 at risk EG00111 affected222 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00010 affected221 at risk EG00113 affected222 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG00022 affected221 at risk EG00115 affected222 at risk
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG00022 affected221 at risk EG00135 affected222 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG00020 affected221 at risk EG00117 affected222 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00023 affected221 at risk EG00118 affected222 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00044 affected221 at risk EG00150 affected222 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00017 affected221 at risk EG00118 affected222 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00037 affected221 at risk EG00133 affected222 at risk
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG00020 affected221 at risk EG00118 affected222 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00021 affected221 at risk EG00123 affected222 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00018 affected221 at risk EG00122 affected222 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected221 at risk EG00112 affected222 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00011 affected221 at risk EG00120 affected222 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00015 affected221 at risk EG0018 affected222 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00027 affected221 at risk EG00123 affected222 at risk
Tremor	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected221 at risk EG00112 affected222 at risk
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0009 affected221 at risk EG00112 affected222 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG00031 affected221 at risk EG00120 affected222 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG00010 affected221 at risk EG00112 affected222 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG00029 affected221 at risk EG00121 affected222 at risk

Ancestor Terms

ID	Term
D018796	Immunoconjugates
D000906	Antibodies
D007136	Immunoglobulins
D012712	Serum Globulins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D005916	Globulins
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides