Evaluation of Monthly Darbepoetin Alfa Dosing for Correct... | NCT00925587

ID	Type	Description	Link
2006-003173-27	EudraCT Number

Label	Type	Description	Intervention Names
Q2W	Active Comparator	Q2W administration of darbepoetin alfa.	Drug: darbepoetin alfa
QM	Active Comparator	QM administration of darbepoetin alfa	Drug: darbepoetin alfa

Name	Type	Description	Arm Group Labels	Other Names
darbepoetin alfa	Drug	Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.	Q2W

Measure	Description	Time Frame
Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)	The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.	Baseline Week 33

Measure	Description	Time Frame
Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.		Baseline to Week 33
Hb at Baseline		Baseline

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Gosford	New South Wales	2250	Australia
Research Site

PubMed Identifier	Type	Citation	Retractions
24506498	Derived	Roger SD, Kolmakova E, Fung M, Malecki R, Vinhas J, Dellanna F, Thomas M, Manamley N, Ferenczi S. Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis. Nephrology (Carlton). 2014 May;19(5):266-74. doi: 10.1111/nep.12214.

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
FG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

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

Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)

The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Posted

Least Squares Mean

95% Confidence Interval

g/dL

Baseline Week 33

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000142 OG001154

Title

Denominators

Categories

Title	Measurements
	OG0002.157(1.984 to 2.330) OG0011.969(1.803 to 2.135)

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	Power = 90% at sample size calculation					Mean Difference (Final Values)	-0.188	Standard Error of the Mean	0.122	2-Sided	95	-0.427	0.052			Darbepoetin alfa QM - Darbepoetin alfa Q2W	Yes	Non-Inferiority or Equivalence	Non-inferiority margin -0.5 g/dL

Secondary

Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline to Week 33

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Baseline

Posted

Mean

Standard Error

g/dL

Baseline

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 3

Posted

Mean

Standard Error

g/dL

Week 3

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 5

Posted

Mean

Standard Error

g/dL

Week 5

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 7

Posted

Mean

Standard Error

g/dL

Week 7

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 9

Posted

Mean

Standard Error

g/dL

Week 9

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 11

Posted

Mean

Standard Error

g/dL

Week 11

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 13

Posted

Mean

Standard Error

g/dL

Week 13

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 15

Posted

Mean

Standard Error

g/dL

Week 15

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 17

Posted

Mean

Standard Error

g/dL

Week 17

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 19

Posted

Mean

Standard Error

g/dL

Week 19

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 21

Posted

Mean

Standard Error

g/dL

Week 21

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 23

Posted

Mean

Standard Error

g/dL

Week 23

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 25

Posted

Mean

Standard Error

g/dL

Week 25

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 27

Posted

Mean

Standard Error

g/dL

Week 27

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 29

Posted

Mean

Standard Error

g/dL

Week 29

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 31

Posted

Mean

Standard Error

g/dL

Week 31

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Hb at Week 33

Posted

Mean

Standard Error

g/dL

Week 33

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 1

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 1

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 3

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 3

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 5

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 5

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 7

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 7

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 9

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 9

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 11

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 11

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 13

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 13

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 15

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 15

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 17

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 17

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 19

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 19

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 21

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 21

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 23

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 23

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 25

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 25

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 27

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 27

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 29

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 29

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose at Week 31

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Week 31

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Weeks 29-33

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 3

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 3

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 5

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 5

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 7

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 7

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 9

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 9

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 11

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 11

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 13

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 13

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 15

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 15

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 17

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 17

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 19

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 19

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 21

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 21

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 23

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 23

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 25

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 25

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 27

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 27

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 29

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 29

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at Week 31

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Week 31

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

µg/wk

Weeks 1-33

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)

Posted

Median

Inter-Quartile Range

Weeks

Weeks 1-33

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Secondary

Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)

Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Posted

Geometric Mean

95% Confidence Interval

ratio

Evaluation Period

ID	Title	Description
OG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
OG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0015 affected180 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0010 affected180 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0012 affected180 at risk
Arrhythmia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0010 affected180 at risk
Atrial flutter	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0006 affected175 at risk EG0013 affected180 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0010 affected180 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Cataract	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Retinal haemorrhage	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Visual impairment	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0010 affected180 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Ileus	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0013 affected180 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Melaena	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Asthenia	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Chest pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Generalised oedema	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Inflammation	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Oedema peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0011 affected180 at risk
Spinal pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Abdominal abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Appendicitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Bronchopneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Erysipelas	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Gangrene	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Lobar pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Peritonitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0003 affected175 at risk EG0011 affected180 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0012 affected180 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0010 affected180 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Blood glucose increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Blood potassium increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
General physical condition abnormal	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
International normalised ratio increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected175 at risk EG0011 affected180 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Convulsion	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Hemiparesis	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Loss of consciousness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Syncope	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0012 affected180 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Azotaemia	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Nephropathy	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0011 affected180 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected175 at risk EG0010 affected180 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0014 affected180 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0007 affected175 at risk EG0014 affected180 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Scrotal swelling	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected175 at risk EG0012 affected180 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0012 affected180 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Aortic aneurysm	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Circulatory collapse	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Extremity necrosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Haematoma	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected175 at risk EG0010 affected180 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected175 at risk EG0012 affected180 at risk
Hypertensive crisis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected175 at risk EG0011 affected180 at risk

ID	Term
D000740	Anemia
D051436	Renal Insufficiency, Chronic

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
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

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

ID	Title	Description
BG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks
BG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Darbepoetin Alfa Q2W	Darbepoetin alfa Intravenous Once Every 2 Weeks			52	175	68	175
EG001	Darbepoetin Alfa QM	Darbepoetin alfa Intravenous Once Monthly			54	180	63	180