Safety and Efficacy Study of BCD-066 Compared to Aranesp®... | NCT02506868

NCT02506868

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
BCD-066	Experimental	Patients in this arm will receive weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks	Drug: Darbepoetin alfa
Aranesp	Active Comparator	Patients in this arm will receive weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks	Drug: Darbepoetin alfa

Name	Type	Description	Arm Group Labels	Other Names
Darbepoetin alfa	Drug	Weekly sc administration of darbepoetin alfa	Aranesp BCD-066

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period		Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 24

Secondary Outcomes

Measure	Description	Time Frame
Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period	Hb concentration between 100 and 120 g/l will be considered as target	Weeks 21 to 24
Mean Darbepoetin Alfa Dose During Evaluation Period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Age between 18 and 75 years
End-stage kidney disease
Need for dialysis for at least 3 months before enrollment
Need for at least 12 hours on standard dialysis procedure weekly
Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3 times a week (stable dose, stable frequency) for at least 3 months before enrollment
Target hemoglobin level (100-120 g/l) for at least 3 months before enrollment
Effective dialysis (Kt/v≥1,2)
TSAT ≥20%, Serum ferritin >200 ng/ml
Patients and their sexual partners with childbearing potential must implement reliable contraceptive measures during all the study treatment, starting 4 weeks prior to the administration of the first dose of investigational product until 4 weeks after the last dose of investigational product. This requirement does not apply to participants who have undergone surgical sterilization. Reliable contraceptive measures include two methods of contraception, including one barrier method
Patients should be able to follow the Protocol procedures (according to Investigator's assessment)

Exclusion Criteria:

Any other causes of anemia except for renal anemia, including folate and B12 deficiency, chronic blood loss, aluminium intoxication, sickle-cell anemia, chronic disease anemia (CRP above 20 mg/l), refractory anemia with blast cells in peripheral blood
Lupus nephritis of kidney disease due to systemic vasculitis
Platelet count below 100х10^9 cells/l
Hemoglobin above 120 g/l or below 100 g/l
Scheduled kidney transplant during study participation period
Binding/neutralizing antibodies against erythropoetin/darbepoetin
History of severe allergic reactions
Vaccination less than 8 weeks before enrollment
Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis
HIV infection, active HBV, HCV
ALT, AST level above 3x ULN
Bone marrow fibrosis
Congestive heart failure (Grade IV NYHA)
Resistant arterial hypertension
Unstable angina
Hemoglobinopathy, MDS, hematologic malignancy
PRCA
Severe secondary hyperparathyroidism (PTH > 9x ULN)
GI bleeding history
Thrombotic events history (myocardial infarction, stroke, TIA, DVT, PATE) less than 6 months before enrollment
Acute hemolysis history
Seizures, including epilepsy
Major surgery in less than 1 month before enrollment
Blood transfusions in less than 3 months before enrollment
Acute inflammatory diseases or exacerbations of chronic inflammation including septic of aseptic inflammation foci
Severe psychiatric disorders
History of malignancy, excluding appropriately treated basal cell carcinoma or cervical carcinoma in situ
Alcohol or drug abuse
Hypersensitivity to darbepoetin alfa of any components of study drugs
Simultaneous participation in other trials or in less than 3 months before enrollment
Pregnancy of breast-feeding

Contacts/Locations Module

Name	Affiliation	Role
Andrey Biryulin, MD	Biocad	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
St. Josaphat Belgorod Regional Clinical Hospital		Belgorod			Russia
Alyans Biomedical - Ural'skaya gruppa

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
FG001	Aranesp

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The outcome includes the mean weekly dose of Darbepoetin Alfa which was administered to the patients during the period from week 21 to week 24 (last 4 weeks of the main period of the study)

FG00098 subjects
FG00198 subjects

The analysis included all patients who received at least one injection of BCD-066 or Aranesp. One patient from Aranesp group was excluded prior to the first administration.

Arm/Group Information

ID	Title	Description
BG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Darbepoetin alfa: weekly sc administration of darbepoetin alfa
BG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Darbepoetin alfa: weekly sc administration of darbepoetin alfa
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

two population: mITT and Per protocol

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	OG0004.695± 10.941 OG0014.641± 8.987

Secondary

Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period

Hb concentration between 100 and 120 g/l will be considered as target

Posted

Count of Participants

Participants

Weeks 21 to 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Mean Darbepoetin Alfa Dose During Evaluation Period

The outcome includes the mean weekly dose of Darbepoetin Alfa which was administered to the patients during the period from week 21 to week 24 (last 4 weeks of the main period of the study)

Posted

Mean

Standard Deviation

micrograms

Week 21 to Week 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Number or Percentage of Patients With Need for Blood Transfusions

Posted

Count of Participants

Participants

Weeks 1 to 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study

Posted

Count of Participants

Participants

Weeks 1 to 20

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Mean Hemoglobin Level During Evaluation Period

The outcome includes the mean hemoglobin level which was registered in the patients during the last 4 weeks of the main period of the study (period from week 21 to week 24)

Posted

Mean

Standard Deviation

gram per liter

Week 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l

Posted

Count of Participants

Participants

Weeks 21 to 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Hemoglobin Level Dynamics

Posted

Mean

Standard Deviation

gram per liter

Weeks 1 to 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Mean Darbepoetin Alfa Dose During the Whole Study

The outcome includes the mean Darbepoetin Alfa Dose During the Whole Study

Posted

Mean

Standard Deviation

micrograms

Week 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Mean Hemoglobin Level During the Whole Study (24 Week)

The outcome includes the measuere of Mean Hemoglobin Level During the Whole Study (during the study period from week 1 to week 24 week)

Posted

Mean

Standard Deviation

gram per liter

Week 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Mean Hematocrit Level During the Whole Study

Posted

Mean

Standard Deviation

percentage of hematocrit (%)

Week 24

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Number of Patients With AE/SAE (AE/SAE Incidence)

The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.

One patient from Aranesp group was excluded prior to the first administration.

Posted

Count of Participants

Participants

Weeks 1 to 52

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) or 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Number of Participants With Grade 3-4 AE/SAE

The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.

One patient from Aranesp group was excluded prior to the first administration.

Posted

Count of Participants

Participants

Weeks 1 to 52

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) or 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Withdrew From Study Due to AE/SAE

The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.

One patient from Aranesp group was excluded prior to the first administration.

Posted

Count of Participants

Participants

Weeks 1 to 52

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) or 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants

Secondary

Number of Participants With Arterial and Venous Thrombotic Events

The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.

One patient from Aranesp group was excluded prior to the first administration.

Posted

Count of Participants

Participants

Weeks 1 to 52

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) or 24 weeks of main period and 28 week of additional period Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

Units	Counts
Participants

Secondary

Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa

The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.

One patient from Aranesp group was excluded prior to the first administration.

Posted

Count of Participants

Participants

Weeks 1 to 52

ID	Title	Description
OG000	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa
OG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa

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	BCD-066	Patients in this arm received weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa	5	98	19	98	84	98
EG001	Aranesp	Patients in this arm received weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Darbepoetin alfa: Weekly sc administration of darbepoetin alfa	4	97	13	97	84	97

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
pneumonia	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
acute gangrenous cholecystitis	Hepatobiliary disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
Chronic circulatory failure	Vascular disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
Sudden cardiac death	Cardiac disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0002 affected98 at risk EG0012 affected97 at risk
Paroxysmal atrial fibrillation	Cardiac disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0011 affected97 at risk
Increased blood pressure	Vascular disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected98 at risk EG0011 affected97 at risk
sepsis	Infections and infestations	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
Vascular access site thrombosis	Injury, poisoning and procedural complications	CTCAE (Unspecified)	Non-systematic Assessment	EG0003 affected98 at risk EG0013 affected97 at risk
Acute myocardial infarction. Relapse of myocardial infarction	Cardiac disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
peptic ulcer aggaravation	Gastrointestinal disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
breast cancer	Reproductive system and breast disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
chronic cholecystitis aggravation	Hepatobiliary disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
cataract	Eye disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
Paget-Schroetter syndrome	Vascular disorders	CTCAE (Unspecified)	Systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
pneumothorax	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
acute gastoentrocolitis	Gastrointestinal disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected97 at risk
Prepatellar hematoma of the left knee	General disorders	CTCAE (Unspecified)	Systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk
cerebrovascular accident	Nervous system disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk
peritonitis	Gastrointestinal disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk
steal syndrome	Vascular disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk
chronic pancreatitis aggravation	Gastrointestinal disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk
diabetic foot	Metabolism and nutrition disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk
pulmonary thromboembolism	Vascular disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk
Dyscirculatory encephalopathy	Nervous system disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected97 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
hyperkalemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG00051 affected98 at risk EG00147 affected97 at risk
lymphopenia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment	EG00011 affected98 at risk EG00112 affected97 at risk
Increased blood pressure	Vascular disorders	CTCAE (Unspecified)	Systematic Assessment	EG00042 affected98 at risk EG00136 affected97 at risk
C-reactive protein increased	Investigations	CTCAE (Unspecified)	Systematic Assessment	EG0008 affected98 at risk EG0014 affected97 at risk
acute respiratory infection	Respiratory, thoracic and mediastinal disorders	CTCAE (Unspecified)	Non-systematic Assessment	EG0006 affected98 at risk EG0015 affected97 at risk
hyperglycemia	Metabolism and nutrition disorders	CTCAE (Unspecified)	Systematic Assessment	EG0008 affected98 at risk EG0019 affected97 at risk
neutropenia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0005 affected98 at risk EG0015 affected97 at risk
leukopenia	Blood and lymphatic system disorders	CTCAE (Unspecified)	Systematic Assessment	EG0005 affected98 at risk EG0014 affected97 at risk

ID	Term
D051436	Renal Insufficiency, Chronic
D000740	Anemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D000068256	Darbepoetin alfa

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins