An Efficacy and Safety Study of Epoetin Alfa for Initiati... | NCT00440557

ID	Type	Description	Link
EPOAKD3001	Other Identifier	Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Label	Type	Description	Intervention Names
TIW: Epoetin alfa 3 injections Weekly/Once Weekly	Experimental	Participants will be administered with epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)	Drug: Epoetin alfa 3 times weekly /once weekly
QW: Epoetin alfa once weekly	Experimental	Participants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU).	Drug: Epoetin alfa once weekly
Q2W: Epoetin alfa once every two weeks	Experimental	Participants will be administered with epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU).	Drug: Epoetin alfa once every two weeks

Name	Type	Description	Arm Group Labels	Other Names
Epoetin alfa 3 times weekly /once weekly	Drug	Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks)

Measure	Description	Time Frame
Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22	The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.	From baseline through Week 22

Measure	Description	Time Frame
Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9	The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.	From baseline to Week 9

Measure	Description	Time Frame
Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment	The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.

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

PubMed Identifier	Type	Citation	Retractions
19808215	Derived	Pergola PE, Gartenberg G, Fu M, Wolfson M, Rao S, Bowers P. A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia. Clin J Am Soc Nephrol. 2009 Nov;4(11):1731-40. doi: 10.2215/CJN.03470509. Epub 2009 Sep 17.

Label	URL
A Randomized,Open-Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens,OnceWeekly and EveryTwoWeeks,With the ThreeTimesWeekly Dosing Regimen for Initiation \& Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease	View source

ID	Title	Description
FG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
FG001	Epoetin Alfa:Once Weekly (QW)

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 Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.

Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization hemoglobin concentration measurement.

Posted

Mean

Standard Deviation

g/dL

From baseline through Week 22

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Units	Counts
Participants	OG000121 OG001124 OG002123

Title

Denominators

Categories

Title	Measurements
	OG0001.81± 0.910 OG0011.59± 0.997 OG0021.27± 0.906

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 is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.				This comparison between QW and TIW was performed prior to comparing Q2W with TIW in the statistical analysis 2 according to a planned stepdown procedure for controlling multiplicity.	Difference of Least Squares Means	-0.17	Standard Error of the Mean	0.106		95	-0.380	0.037				Yes	Non-Inferiority or Equivalence

Other Pre-specified

Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.

Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.

Posted

Number

participants

From baseline to Week 22

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Other Pre-specified

Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.

Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.

Posted

Mean

Standard Deviation

g/dL

From baseline to Week 22

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Other Pre-specified

Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment

Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.

Safety population. The safety population was defined as all subjects who received at least 1 injection of study drug.

Posted

Number

participants

From baseline to Week 22

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Other Pre-specified

Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment

Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.

Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.

Posted

Number

participants

From baseline to Week 22

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Other Pre-specified

Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment

Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.

Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.

Posted

Number

participants

From baseline to Week 22

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Post-Hoc

Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment

Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant.

Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.

Posted

Mean

Standard Deviation

g/dL/2 weeks

From baseline to Week 22

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Secondary

Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.

Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization Hb concentration measurement.

Posted

Number

participants

From baseline to Week 9

ID	Title	Description
OG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
OG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
OG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0004 affected123 at risk EG0014 affected125 at risk EG0026 affected125 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0012 affected125 at risk EG0025 affected125 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Bradycardia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Arrhythmia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Subendocardial ischaemia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Pneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 affected123 at risk EG0012 affected125 at risk EG0022 affected125 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0022 affected125 at risk
Cellulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Bronchitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Sepsis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Septic shock	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Staphylococcal infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Urosepsis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected123 at risk EG0014 affected125 at risk EG0020 affected125 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0022 affected125 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0021 affected125 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Oral intake reduced	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0004 affected123 at risk EG0013 affected125 at risk EG0025 affected125 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected123 at risk EG0012 affected125 at risk EG0023 affected125 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Azotaemia	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Renal impairment	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Syncope	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0022 affected125 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0021 affected125 at risk
Convulsion	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Brain stem infarction	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Dizziness	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Encephalomalacia	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Encephalopathy	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0023 affected125 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0022 affected125 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0012 affected125 at risk EG0020 affected125 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Appendicitis perforated	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0022 affected125 at risk
Hypotension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Aortic stenosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Arterial stenosis limb	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Hypertension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Hypertensive crisis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Peripheral embolism	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Vascular pseudoaneurysm ruptured	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0023 affected125 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0023 affected125 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Device electrical finding	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Failure to capture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Open wound	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0023 affected125 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0021 affected125 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Prostate cancer metastitic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Chest pain	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0012 affected125 at risk EG0021 affected125 at risk
Necrosis	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Oedema	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Oedema peripheral	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Pyrexia	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0012 affected125 at risk EG0021 affected125 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Mental status changes	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Aggression	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Blood creatinine increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Walking disability	Social circumstances	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Aortic valve disease	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0020 affected125 at risk
Cardiac arrest	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0011 affected125 at risk EG0020 affected125 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected123 at risk EG0010 affected125 at risk EG0021 affected125 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0009 affected123 at risk EG00115 affected125 at risk EG00214 affected125 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0004 affected123 at risk EG0017 affected125 at risk EG0027 affected125 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00013 affected123 at risk EG00113 affected125 at risk EG00210 affected125 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00013 affected123 at risk EG0019 affected125 at risk EG0029 affected125 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected123 at risk EG0018 affected125 at risk EG00210 affected125 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected123 at risk EG0013 affected125 at risk EG00214 affected125 at risk
Fatigue	General disorders	MedDRA 10.1	Systematic Assessment	EG00013 affected123 at risk EG0019 affected125 at risk EG00212 affected125 at risk
Oedema	General disorders	MedDRA 10.1	Systematic Assessment	EG00013 affected123 at risk EG00111 affected125 at risk EG00210 affected125 at risk
Oedema peripheral	General disorders	MedDRA 10.1	Systematic Assessment	EG00015 affected123 at risk EG0017 affected125 at risk EG00212 affected125 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG00015 affected123 at risk EG00110 affected125 at risk EG00214 affected125 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected123 at risk EG0014 affected125 at risk EG0024 affected125 at risk
Dizziness	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected123 at risk EG0017 affected125 at risk EG00216 affected125 at risk
Headache	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00015 affected123 at risk EG0019 affected125 at risk EG0023 affected125 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00013 affected123 at risk EG0011 affected125 at risk EG0026 affected125 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0009 affected123 at risk EG0018 affected125 at risk EG0022 affected125 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected123 at risk EG0016 affected125 at risk EG0026 affected125 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected123 at risk EG0012 affected125 at risk EG0027 affected125 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected123 at risk EG0015 affected125 at risk EG00211 affected125 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0007 affected123 at risk EG0017 affected125 at risk EG0025 affected125 at risk
Hypertension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG00015 affected123 at risk EG00118 affected125 at risk EG00210 affected125 at risk
Hypotension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected123 at risk EG0015 affected125 at risk EG00210 affected125 at risk
Insomnia	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected123 at risk EG0018 affected125 at risk EG0024 affected125 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected123 at risk EG0010 affected125 at risk EG0027 affected125 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Glendale	Arizona		United States

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

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D051437	Renal Insufficiency
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

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

ID	Title	Description
BG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
BG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
BG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)	Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)	36	123	93	123
EG001	Epoetin Alfa:Once Weekly (QW)	Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)	41	125	85	125
EG002	Epoetin Alfa:Once Every Two Weeks (Q2W)	Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)	42	125	102	125