PROCRIT Extended Dosing For Maintenance of Hemoglobin in... | NCT00440466

NCT00440466

ID	Type	Description	Link
EPOAKD3002

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

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
001	Experimental	epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks	Drug: epoetin alfa
003	Experimental	epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk	Drug: epoetin alfa
002	Experimental	epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks	Drug: epoetin alfa

Name	Type	Description	Arm Group Labels	Other Names
epoetin alfa	Drug	Continue pre-study once weekly dose of epoetin alfa for 36 weeks	001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment		from baseline (Week 1) to the last 12 weeks of treatment

Measure	Description	Time Frame
Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)		Weeks 13-37

Other Outcomes

Measure	Description	Time Frame
Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)		36 weeks of treatment
Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)		36 weeks of treatment

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

References Module

Label	URL
A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, with Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects with Chronic Kidney Disease	View source

ID	Title	Description
FG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
FG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00070.3± 13.04 BG00171.7± 10.63 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00068 BG00173 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

Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment

Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.

Posted

Mean

Standard Deviation

g/dL

from baseline (Week 1) to the last 12 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000107 OG001105 OG002215

Title

Denominators

Categories

Title	Measurements
	OG000-0.02± 0.728 OG001-0.10± 0.774 OG002-0.19± 0.738

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	The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-2-weeks (Q2W) and once-weekly (QW) groups would be lower than -1 g/dL.	ANCOVA				Difference of Least Squares Means	-0.03	Standard Error of the Mean	0.092	2-Sided	95	-0.208	0.153				Yes	Non-Inferiority or Equivalence	Assuming a difference in the mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment of -0.3 g/dL between QW and Q2W groups, a pooled standard deviation of 1.5 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 200 subjects (100 per group) would provide 90% power to demonstrate that Q2W group would not inferior to QW group for an overall 2-sided 0.05 significance level.

Secondary

Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)

Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.

Posted

Median

Full Range

Proportion

Weeks 13-37

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Other Pre-specified

Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)

Safety population defined as all participants who received at least 1 injection of study drug

Posted

Number

Participants

36 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Other Pre-specified

Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)

Safety population defined as all participants who received at least 1 injection of study drug

Posted

Mean

Standard Deviation

g/dL

36 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Other Pre-specified

Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

Safety population defined as all participants who received at least 1 injection of study drug

Posted

Number

Particpants

36 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Other Pre-specified

Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

Posted

Number

Participants

36 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Other Pre-specified

Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

Safety population defined as all participants who received at least 1 injection of study drug

Posted

Number

Participants

36 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Other Pre-specified

Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)

Safety population defined as all participants who received at least 1 injection of study drug

Posted

Mean

Standard Deviation

g/dL/2 weeks

36 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants Who Died

Posted

Number

Participants

36 weeks of treatment

ID	Title	Description
OG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
OG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
OG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks	24	108	59	108
EG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks	28	107	59	107
EG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk	56	215	116	215

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected108 at risk EG0014 affected107 at risk EG0021 affected215 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Splenic cyst	Blood and lymphatic system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected108 at risk EG0018 affected107 at risk EG0024 affected215 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected107 at risk EG0022 affected215 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0012 affected107 at risk EG0020 affected215 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0022 affected215 at risk
Cardiac failure	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0022 affected215 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Angina unstable	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Cardiac arrest	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0023 affected215 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Gastric mucosal lesion	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Chest pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected108 at risk EG0012 affected107 at risk EG0023 affected215 at risk
Asthenia	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Sudden cardiac death	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Chest discomfort	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Pyrexia	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0023 affected215 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0022 affected215 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Viral infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0002 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Diverticulitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Intervertebral discitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Lobar pneumonia	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Paronychia	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Sepsis syndrome	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Urosepsis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
International normalised ratio increased	Investigations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0022 affected215 at risk
Blood creatinine increased	Investigations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected108 at risk EG0012 affected107 at risk EG0020 affected215 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected107 at risk EG0023 affected215 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Metastatic carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected107 at risk EG0023 affected215 at risk
Syncope	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0022 affected215 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0022 affected215 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Cerebral infarction	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Cervical cord compression	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Migraine	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Presyncope	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Vascular dementia	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Delirium	Psychiatric disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected108 at risk EG0015 affected107 at risk EG0021 affected215 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0012 affected107 at risk EG0021 affected215 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Renal impairment	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0022 affected215 at risk
Azotaemia	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0012 affected107 at risk EG0021 affected215 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0022 affected215 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0020 affected215 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Increased tendency to bruise	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0023 affected215 at risk
Aortic aneurysm	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Hypertensive crisis	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected108 at risk EG0011 affected107 at risk EG0020 affected215 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0022 affected215 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0011 affected107 at risk EG0021 affected215 at risk
Arteriosclerosis	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Haemorrhage	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk
Thrombophlebitis	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected108 at risk EG0010 affected107 at risk EG0021 affected215 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected108 at risk EG0015 affected107 at risk EG00210 affected215 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0008 affected108 at risk EG0015 affected107 at risk EG00214 affected215 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected108 at risk EG0015 affected107 at risk EG00215 affected215 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected108 at risk EG0016 affected107 at risk EG00210 affected215 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected108 at risk EG0016 affected107 at risk EG00212 affected215 at risk
Oedema	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected108 at risk EG00113 affected107 at risk EG00216 affected215 at risk
Oedema peripheral	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected108 at risk EG00110 affected107 at risk EG00214 affected215 at risk
Fatigue	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected108 at risk EG0015 affected107 at risk EG00215 affected215 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG00012 affected108 at risk EG0018 affected107 at risk EG00213 affected215 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0004 affected108 at risk EG0016 affected107 at risk EG00215 affected215 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0007 affected108 at risk EG0016 affected107 at risk EG0029 affected215 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0007 affected108 at risk EG0017 affected107 at risk EG00218 affected215 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected108 at risk EG0014 affected107 at risk EG0027 affected215 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected108 at risk EG0015 affected107 at risk EG00210 affected215 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected108 at risk EG0014 affected107 at risk EG00211 affected215 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0007 affected108 at risk EG0015 affected107 at risk EG0027 affected215 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected108 at risk EG0017 affected107 at risk EG00218 affected215 at risk
Headache	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected108 at risk EG0016 affected107 at risk EG00214 affected215 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected108 at risk EG0017 affected107 at risk EG00215 affected215 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG00011 affected108 at risk EG00114 affected107 at risk EG00224 affected215 at risk

ID	Term
D000740	Anemia
D007674	Kidney Diseases
D051436	Renal Insufficiency, Chronic

Ancestor Terms

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

ID	Term
D000068817	Epoetin Alfa

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

Facility	Status	City	State	ZIP	Country	Contacts
		Chula Vista	California		United States

ID	Title	Description
BG000	Epoetin Alfa QW	Continue pre-study once weekly dose of epoetin alfa for 36 weeks
BG001	Epoetin Alfa Q2W	Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
BG002	Epoetin Alfa Q4W	Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
BG003	Total	Total of all reporting groups