Trial Outcomes & Findings for A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia (NCT NCT00090753)

NCT ID: NCT00090753

Last Updated: 2012-02-14

Results Overview

Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1228 participants
• Primary outcome timeframe: Baseline to the end of the study (Up to 49 Months)
• Results posted on: 2012-02-14

Participant Flow

Participants were enrolled in one of the following Phase II or Phase III studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] or BA17284[NCT00081484]

Participant milestones

Measure	Methoxy Polyethylene Glycol-Epoetin Beta Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Comparator ESA Patients received the same comparator erythropoiesis stimulating agent (ESA) \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
First Treatment Period STARTED	748	480
First Treatment Period COMPLETED	492	302
First Treatment Period NOT COMPLETED	256	178
Extended Treatment Period STARTED	453	250
Extended Treatment Period COMPLETED	94	59
Extended Treatment Period NOT COMPLETED	359	191

Reasons for withdrawal

Measure	Methoxy Polyethylene Glycol-Epoetin Beta Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Comparator ESA Patients received the same comparator erythropoiesis stimulating agent (ESA) \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
First Treatment Period Adverse Event	20	8
First Treatment Period Death	88	62
First Treatment Period Lack of Efficacy	2	1
First Treatment Period Refused Treatment	32	25
First Treatment Period Lost to Follow-up	4	4
First Treatment Period Renal Transplant	70	50
First Treatment Period Mircera Commercialization	1	0
First Treatment Period Other Unrelated to Safety and Efficacy	39	28
Extended Treatment Period Adverse Event	11	0
Extended Treatment Period Death	58	30
Extended Treatment Period Lack of Efficacy	1	0
Extended Treatment Period Refused Treatment	18	12
Extended Treatment Period Lost to Follow-up	3	1
Extended Treatment Period Renal Transplant	15	12
Extended Treatment Period Mircera Commercialization	188	93
Extended Treatment Period Other Unrelated to Safety and Efficacy	65	43

Baseline Characteristics

A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Baseline characteristics by cohort

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=748 Participants Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Comparator ESA n=480 Participants Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.	Total n=1228 Participants Total of all reporting groups
Age Continuous	61.2 years STANDARD_DEVIATION 14.80 • n=5 Participants	61.9 years STANDARD_DEVIATION 14.42 • n=7 Participants	61.5 years STANDARD_DEVIATION 14.65 • n=5 Participants
Sex: Female, Male Female	327 Participants n=5 Participants	223 Participants n=7 Participants	550 Participants n=5 Participants
Sex: Female, Male Male	421 Participants n=5 Participants	257 Participants n=7 Participants	678 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the end of the study (Up to 49 Months)

Population: Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.

Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.

Outcome measures

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=735 Participants Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Comparator ESA n=476 Participants Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	-0.55 g/dL Standard Deviation 1.832	-0.38 g/dL Standard Deviation 1.614

SECONDARY outcome

Timeframe: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

Population: Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.

See the adverse events section of the results for more information.

Outcome measures

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=748 Participants Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Comparator ESA n=480 Participants Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Percentage of Patients Who Had at Least 1 Adverse Event	94.3 Percentage of participants	93.3 Percentage of participants

Adverse Events

Methoxy Polyethylene Glycol-Epoetin Beta

Serious events: 499 serious events

Other events: 624 other events

Deaths: 0 deaths

Comparator ESA

Serious events: 316 serious events

Other events: 390 other events

Deaths: 0 deaths

Serious adverse events

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=748 participants at risk Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Comparator ESA n=480 participants at risk Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders HYPERPYREXIA	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders HERNIA OBSTRUCTIVE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders HYPERTHERMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders SUDDEN CARDIAC DEATH	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders VESSEL PUNCTURE SITE HAEMATOMA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders CALCINOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders CATHETER SITE HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders CHEST DISCOMFORT	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders CHILLS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders IMPAIRED HEALING	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders IMPLANT SITE NECROSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders INFLAMMATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders MULTI-ORGAN DISORDER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders OEDEMA DUE TO RENAL DISEASE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders PAIN	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders PSEUDOCYST	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL FAILURE CHRONIC	2.9% 22/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	3.1% 15/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL FAILURE ACUTE	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders HAEMATURIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders AZOTAEMIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders CALCULUS URETERIC	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders NEPHROLITHIASIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL FAILURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL IMPAIRMENT	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders NEPHROPATHY TOXIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders OBSTRUCTIVE UROPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders PYELOCALIECTASIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL CYST RUPTURED	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL DISORDER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL HYPERTENSION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL TUBULAR NECROSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders URINARY BLADDER POLYP	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders CHEST PAIN	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders MULTI-ORGAN FAILURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders ASTHENIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PNEUMONIA	7.1% 53/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	7.3% 35/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations SEPSIS	3.2% 24/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	2.5% 12/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CELLULITIS	2.0% 15/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.5% 7/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BRONCHITIS	1.3% 10/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.7% 8/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GASTROENTERITIS	1.5% 11/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CATHETER SEPSIS	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ARTERIOVENOUS GRAFT SITE INFECTION	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.0% 5/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GANGRENE	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.0% 5/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations SEPTIC SHOCK	1.1% 8/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BRONCHOPNEUMONIA	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.0% 5/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CATHETER RELATED INFECTION	1.1% 8/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations URINARY TRACT INFECTION	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GASTROENTERITIS VIRAL	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations OSTEOMYELITIS	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations DIABETIC GANGRENE	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations DIVERTICULITIS	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CENTRAL LINE INFECTION	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations APPENDICITIS	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ARTERIOVENOUS FISTULA SITE INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ENDOCARDITIS	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations UROSEPSIS	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INFECTED SKIN ULCER	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PERITONITIS BACTERIAL	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations WOUND INFECTION	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BACTERAEMIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CATHETER BACTERAEMIA	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CHOLECYSTITIS INFECTIVE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations DIABETIC FOOT INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INTERVERTEBRAL DISCITIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations LUNG INFECTION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ABDOMINAL WALL ABSCESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ABSCESS LIMB	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BACTERIAL INFECTION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BACTERIAL SEPSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CATHETER SITE INFECTION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CELLULITIS GANGRENOUS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ERYSIPELAS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations FUNGAEMIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GRAFT INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GROIN ABSCESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PNEUMONIA STAPHYLOCOCCAL	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PNEUMONIA STREPTOCOCCAL	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PYELONEPHRITIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations STREPTOCOCCAL SEPSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations VIRAL INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ABDOMINAL SEPSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ANOGENITAL WARTS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ARTERIOSCLEROTIC GANGRENE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ARTERITIS INFECTIVE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ARTHRITIS BACTERIAL	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ARTHRITIS INFECTIVE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BACTERIAL DIARRHOEA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BALANOPOSTHITIS INFECTIVE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CELLULITIS OF MALE EXTERNAL	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GENITAL ORGAN CELLULITIS STREPTOCOCCAL	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CHRONIC TONSILLITIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations CYSTITIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations DISSEMINATED TUBERCULOSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations EMPHYSEMATOUS CHOLECYSTITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations EMPYEMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ENDOCARDITIS STAPHYLOCOCCAL	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ENTEROCOCCAL SEPSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ESCHERICHIA SEPSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations EYE INFECTION STAPHYLOCOCCAL	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations FUNGAL PERITONITIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GASTRIC ULCER HELICOBACTER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations HAEMATOMA INFECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations HEPATITIS C	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INFECTED BITES	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INFECTED CYST	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INFECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INFLUENZA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations KLEBSIELLA SEPSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations LIVER ABSCESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations LOBAR PNEUMONIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations LOCALISED INFECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations NOSOCOMIAL INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations ORAL INFECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations OSTEOMYELITIS CHRONIC	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PANCREAS INFECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PAROTID ABSCESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PHARYNGEAL ABSCESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PHARYNGITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PNEUMOCOCCAL SEPSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PNEUMONIA BACTERIAL	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PNEUMONIA KLEBSIELLA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PNEUMONIA PRIMARY ATYPICAL	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations POST PROCEDURAL INFECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations POST PROCEDURAL SEPSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PSEUDOMEMBRANOUS COLITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PULMONARY SEPSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations PULMONARY TUBERCULOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations RECTAL ABSCESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations SEPTIC ARTHRITIS STAPHYLOCOCCAL	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations SERRATIA BACTERAEMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations SERRATIA INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations STAPHYLOCOCCAL ABSCESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations STAPHYLOCOCCAL OSTEOMYELITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations TUBERCULOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations TUBERCULOUS PLEURISY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations WEST NILE VIRAL INFECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders MYOCARDIAL INFARCTION	3.6% 27/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	3.1% 15/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	2.5% 19/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.4% 21/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	3.5% 26/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	2.1% 10/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ATRIAL FIBRILLATION	2.1% 16/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.0% 19/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIAC ARREST	2.1% 16/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	2.3% 11/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ANGINA PECTORIS	2.1% 16/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.9% 9/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CORONARY ARTERY DISEASE	1.2% 9/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.9% 9/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ACUTE CORONARY SYNDROME	1.3% 10/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ATRIAL FLUTTER	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders VENTRICULAR FIBRILLATION	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders BRADYCARDIA	1.1% 8/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIAC FAILURE	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ARRHYTHMIA	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIOGENIC SHOCK	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIOPULMONARY FAILURE	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ANGINA UNSTABLE	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CORONARY ARTERY STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders PERICARDITIS	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders VENTRICULAR TACHYCARDIA	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders LEFT VENTRICULAR FAILURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders TACHYCARDIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIAC FAILURE CHRONIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders COR PULMONALE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CORONARY ARTERY OCCLUSION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders PALPITATIONS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders SICK SINUS SYNDROME	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders AORTIC VALVE STENOSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ATRIOVENTRICULAR DISSOCIATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIOMYOPATHY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CARDIOVASCULAR DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CONGESTIVE CARDIOMYOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders CORONARY ARTERY DISSECTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ELECTROMECHANICAL DISSOCIATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders HYPERTENSIVE CARDIOMYOPATHY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders HYPERTENSIVE HEART DISEASE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders HYPERTROPHIC CARDIOMYOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders LEFT VENTRICULAR HYPERTROPHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders NODAL ARRHYTHMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders PERICARDIAL DISEASE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders PERICARDIAL EFFUSION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders SINUS ARRHYTHMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders TACHYARRHYTHMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders VENTRICULAR HYPERTROPHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA THROMBOSIS	3.5% 26/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.2% 20/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS GRAFT THROMBOSIS	2.1% 16/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.7% 8/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE COMPLICATION	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.9% 9/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	1.5% 11/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PROCEDURAL HYPOTENSION	1.2% 9/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications VASCULAR GRAFT COMPLICATION	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications HIP FRACTURE	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA ANEURYSM	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PELVIC FRACTURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS GRAFT SITE HAEMORRHAGE	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications TENDON RUPTURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications GRAFT THROMBOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications HEAD INJURY	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications OVERDOSE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications WRIST FRACTURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications CONCUSSION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FIBULA FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications JOINT INJURY	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PNEUMOTHORAX TRAUMATIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PUBIC RAMI FRACTURE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications THERAPEUTIC AGENT TOXICITY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ACETABULUM FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ALCOHOL POISONING	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA OCCLUSION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE HAEMATOMA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS GRAFT ANEURYSM	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications CHEST INJURY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications CONTUSION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications DELAYED RECOVERY FROM ANAESTHESIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications DEVICE MALFUNCTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications DIALYSIS DEVICE COMPLICATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications DISLOCATION OF JOINT PROSTHESIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FALL	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FOOT FRACTURE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FOREARM FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications FRACTURED COCCYX	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications HEPATIC HAEMATOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications MUSCLE RUPTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PERIORBITAL HAEMATOMA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PERIRENAL HAEMATOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POST PROCEDURAL MYOCARDIAL INFARCTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POST PROCEDURAL PULMONARY EMBOLISM	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POSTOPERATIVE FEVER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POSTOPERATIVE WOUND COMPLICATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications POSTPERICARDIOTOMY SYNDROME	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PROCEDURAL COMPLICATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PROCEDURAL VOMITING	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications SKULL FRACTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications SOFT TISSUE INJURY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications SPLENIC RUPTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications SUBDURAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications SYNOVIAL RUPTURE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders CATHETER RELATED COMPLICATION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ULNA FRACTURE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications UROSTOMY COMPLICATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications WOUND	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	1.1% 8/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.7% 8/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders PERITONITIS	1.1% 8/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTRITIS	1.2% 9/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DIARRHOEA	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders PANCREATITIS	1.1% 8/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ABDOMINAL PAIN	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders CONSTIPATION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTRIC ULCER HAEMORRHAGE	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders VOMITING	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders COLITIS ISCHAEMIC	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders COLITIS	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders COLONIC POLYP	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders INTESTINAL INFARCTION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders MELAENA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ABDOMINAL HERNIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DIVERTICULAR PERFORATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DUODENITIS	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ILEUS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders INGUINAL HERNIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders PANCREATITIS ACUTE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ABDOMINAL STRANGULATED HERNIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders CAECITIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DIVERTICULUM	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DIVERTICULUM INTESTINAL	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DUODENAL ULCER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTRITIS HAEMORRHAGIC	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders LARGE INTESTINAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders PANCREATITIS CHRONIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders REFLUX OESOPHAGITIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders SUBILEUS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ABDOMINAL HERNIA OBSTRUCTIVE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ACUTE ABDOMEN	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ASCITES	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DIVERTICULITIS INTESTINAL HAEMORRHAGIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DUODENAL OBSTRUCTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DUODENAL ULCER PERFORATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DUODENITIS HAEMORRHAGIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DYSPHAGIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders EROSIVE DUODENITIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders EROSIVE OESOPHAGITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders FLATULENCE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTRIC DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTRITIS EROSIVE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTRODUODENITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTROINTESTINAL OBSTRUCTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTROINTESTINAL TELANGIECTASIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders GASTROINTESTINAL ULCER HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ILEUS PARALYTIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders INTESTINAL PERFORATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders IRRITABLE BOWEL SYNDROME	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders MEGACOLON	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders PEPTIC ULCER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders RETROPERITONEAL FIBROSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders RETROPERITONEAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.7% 8/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CEREBRAL HAEMORRHAGE	1.1% 8/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders ISCHAEMIC STROKE	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CEREBRAL INFARCTION	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders SYNCOPE	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CAROTID ARTERY STENOSIS	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CARPAL TUNNEL SYNDROME	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HAEMORRHAGIC STROKE	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CEREBROVASCULAR DISORDER	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CONVULSION	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CEREBRAL ISCHAEMIA	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders ISCHAEMIC CEREBRAL INFARCTION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders PRESYNCOPE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders DIZZINESS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders EMBOLIC CEREBRAL INFARCTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders EMBOLIC STROKE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders EPILEPSY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HEADACHE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HYPOGLYCAEMIC COMA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HYPOXIC ENCEPHALOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders LACUNAR INFARCTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders URAEMIC NEUROPATHY	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders ALTERED STATE OF CONSCIOUSNESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders ANOXIC ENCEPHALOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders BALANCE DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders BENIGN INTRACRANIAL HYPERTENSION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CEREBRAL ARTERIOSCLEROSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CEREBRAL ATROPHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders CERVICAL MYELOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders COGNITIVE DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders COMA HEPATIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders COMPLEX PARTIAL SEIZURES	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders DEMENTIA ALZHEIMER'S TYPE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders DEMENTIA WITH LEWY BODIES	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders ENCEPHALOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HAEMORRHAGIC CEREBRAL INFARCTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HYDROCEPHALUS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HYPERTENSIVE ENCEPHALOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders INTRACRANIAL HAEMATOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders MUSCLE SPASTICITY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders NEURALGIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders NEUROTOXICITY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders PARKINSON'S DISEASE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders PERIPHERAL SENSORIMOTOR NEUROPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders POLYNEUROPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders SENILE DEMENTIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders SPONDYLITIC MYELOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders STUPOR	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HYPOTENSION	1.6% 12/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HYPERTENSION	1.2% 9/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders PERIPHERAL ISCHAEMIA	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders DEEP VEIN THROMBOSIS	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders DIABETIC VASCULAR DISORDER	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HYPERTENSIVE CRISIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ARTERIAL THROMBOSIS LIMB	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders FEMORAL ARTERIAL STENOSIS	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders AORTIC ANEURYSM RUPTURE	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ARTERIAL STENOSIS LIMB	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HYPERTENSIVE EMERGENCY	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VENOUS STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ACCELERATED HYPERTENSION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders AORTIC STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ARTERIAL STENOSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ARTERIOSCLEROSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ARTERIOSCLEROSIS OBLITERANS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders CIRCULATORY COLLAPSE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders EXTREMITY NECROSIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders FEMORAL ARTERY OCCLUSION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ILIAC ARTERY STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders INTERMITTENT CLAUDICATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders STEAL SYNDROME	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ANEURYSM	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ANEURYSM RUPTURED	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ANGIOPATHY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders AORTIC ANEURYSM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders AORTIC DISSECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ARTERIAL DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders BRACHIOCEPHALIC VEIN STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders FEMORAL ARTERY EMBOLISM	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HAEMATOMA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HYPOVOLAEMIC SHOCK	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders ISCHAEMIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders JUGULAR VEIN THROMBOSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders MICROANGIOPATHY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders PERIPHERAL ARTERY ANEURYSM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders PHLEBITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders SUBCLAVIAN VEIN THROMBOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VASCULAR CALCIFICATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VASCULAR RUPTURE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VASCULAR STENOSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VASCULITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VENA CAVA THROMBOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VENOUS INSUFFICIENCY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders VENOUS THROMBOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	1.2% 9/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	2.5% 12/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.3% 10/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.5% 7/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.0% 5/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.80% 6/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders NON-CARDIOGENIC PULMONARY OEDEMA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders BRONCHITIS CHRONIC	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders CHOKING	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders COUGH	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders HYDROTHORAX	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders MEDIASTINAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PULMONARY GRANULOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders PULMONARY VASCULITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders TRACHEAL ULCER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMMATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders WEGENER'S GRANULOMATOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders FLUID OVERLOAD	2.1% 16/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	2.3% 11/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPERKALAEMIA	2.0% 15/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	2.5% 12/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	2.1% 10/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders DIABETIC FOOT	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.5% 7/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders CACHEXIA	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.0% 5/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders DEHYDRATION	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders GOUT	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders CALCIPHYLAXIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders FLUID RETENTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPERVOLAEMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders DEATH	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.7% 8/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders PYREXIA	1.3% 10/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.0% 5/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders NON-CARDIAC CHEST PAIN	1.2% 9/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders CATHETER THROMBOSIS	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders SUDDEN DEATH	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.67% 5/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER METASTATIC	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL NEOPLASM	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOID CYSTIC CARCINOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER NEOPLASM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER IN SITU	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER METASTATIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PLEURAL EFFUSION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LIVER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC GASTRIC CANCER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MULTIPLE MYELOMA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC NEOPLASM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARATHYROID TUMOUR	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER METASTATIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL ONCOCYTOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER METASTATIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER STAGE UNSPECIFIED	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NEOPLASM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) URINARY TRACT NEOPLASM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders BACK PAIN	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders COSTOCHONDRITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders DACTYLITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders FASCIITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders HAEMARTHROSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders MUSCLE HAEMORRHAGE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders MYOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders OSTEITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders OSTEODYSTROPHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders OSTEOLYSIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders SOFT TISSUE NECROSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders SYNOVITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Endocrine disorders HYPERPARATHYROIDISM SECONDARY	2.0% 15/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Endocrine disorders HYPERPARATHYROIDISM TERTIARY	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Endocrine disorders HYPERPARATHYROIDISM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Endocrine disorders HYPERTHYROIDISM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Endocrine disorders GOITRE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders CHOLELITHIASIS	0.94% 7/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders CHOLECYSTITIS	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders BILE DUCT OBSTRUCTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders BILE DUCT STENOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders BILE DUCT STONE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders GALLBLADDER POLYP	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders HEPATIC CONGESTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders HEPATIC FIBROSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders HEPATITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders HEPATOSPLENOMEGALY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Hepatobiliary disorders JAUNDICE CHOLESTATIC	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders MENTAL STATUS CHANGES	0.53% 4/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.0% 5/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders CONFUSIONAL STATE	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders ANXIETY	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders DEPRESSION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders ACUTE PSYCHOSIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders ANXIETY DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders BIPOLAR I DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders COMPLETED SUICIDE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders DELIRIUM	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders DEPRESSION SUICIDAL	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders DISORIENTATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders MAJOR DEPRESSION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders PSYCHOTIC DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders SUICIDE ATTEMPT	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders SKIN ULCER	1.2% 9/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders DRY GANGRENE	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders DERMATITIS	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders DIABETIC NEUROPATHIC ULCER	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders LIPODYSTROPHY ACQUIRED	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders PENILE ULCERATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders SKIN DISORDER	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders SKIN FISSURES	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders ANAEMIA	1.3% 10/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	1.2% 6/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders COAGULOPATHY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders HEPARIN-INDUCED THROMBOCYTOPENIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders HYPOPROTHROMBINAEMIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Eye disorders CATARACT	0.40% 3/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.83% 4/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Eye disorders GLAUCOMA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Eye disorders RETINAL DETACHMENT	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders CERVIX INFLAMMATION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders CYSTOCELE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders GENITAL PROLAPSE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders PROSTATISM	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders PROSTATITIS	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders TESTICULAR INFARCTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Reproductive system and breast disorders UTERINE CERVICAL SQUAMOUS METAPLASIA	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Immune system disorders KIDNEY TRANSPLANT REJECTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.62% 3/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Immune system disorders ANAPHYLACTIC REACTION	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Immune system disorders ANAPHYLACTOID REACTION	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Immune system disorders CONTRAST MEDIA ALLERGY	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Immune system disorders DRUG HYPERSENSITIVITY	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Congenital, familial and genetic disorders GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC	0.27% 2/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Congenital, familial and genetic disorders CONGENITAL CYSTIC KIDNEY DISEASE	0.13% 1/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.00% 0/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Ear and labyrinth disorders VERTIGO	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.42% 2/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Ear and labyrinth disorders VERTIGO POSITIONAL	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Investigations BACTERIAL CULTURE POSITIVE	0.00% 0/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	0.21% 1/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.

Other adverse events

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=748 participants at risk Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Comparator ESA n=480 participants at risk Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Infections and infestations NASOPHARYNGITIS	14.3% 107/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	13.3% 64/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	10.8% 81/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	13.1% 63/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations URINARY TRACT INFECTION	10.3% 77/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	11.9% 57/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations BRONCHITIS	10.0% 75/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	10.2% 49/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations INFLUENZA	6.4% 48/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.8% 23/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Infections and infestations GASTROENTERITIS	4.4% 33/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.6% 27/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders DIARRHOEA	18.9% 141/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	20.0% 96/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders VOMITING	9.8% 73/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	9.2% 44/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders NAUSEA	7.9% 59/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	8.5% 41/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders CONSTIPATION	7.0% 52/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	8.5% 41/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ABDOMINAL PAIN	6.1% 46/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.6% 22/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	4.9% 37/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.6% 27/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	10.0% 75/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	11.7% 56/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders BACK PAIN	9.9% 74/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	9.2% 44/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	10.2% 76/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	8.5% 41/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders ARTHRALGIA	8.7% 65/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	8.8% 42/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	7.4% 55/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	6.2% 30/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	5.9% 44/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.0% 24/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications PROCEDURAL HYPOTENSION	13.0% 97/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	11.7% 56/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE COMPLICATION	11.1% 83/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	7.5% 36/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA THROMBOSIS	7.5% 56/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.0% 24/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications ARTERIOVENOUS GRAFT THROMBOSIS	7.1% 53/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.4% 26/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications CONTUSION	4.5% 34/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.6% 27/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Injury, poisoning and procedural complications VASCULAR GRAFT COMPLICATION	5.2% 39/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.6% 22/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HYPERTENSION	22.3% 167/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	22.7% 109/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Vascular disorders HYPOTENSION	4.1% 31/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.4% 26/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders FLUID OVERLOAD	11.1% 83/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	7.9% 38/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPERKALAEMIA	6.3% 47/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	7.7% 37/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	6.3% 47/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.6% 22/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders COUGH	10.6% 79/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	12.1% 58/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	8.3% 62/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	8.5% 41/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Nervous system disorders HEADACHE	11.1% 83/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	9.0% 43/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders INSOMNIA	5.2% 39/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	6.9% 33/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Psychiatric disorders DEPRESSION	5.1% 38/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	4.4% 21/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Endocrine disorders HYPERPARATHYROIDISM SECONDARY	7.6% 57/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	9.2% 44/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Skin and subcutaneous tissue disorders PRURITUS	7.9% 59/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	7.3% 35/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
General disorders PYREXIA	7.0% 52/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.6% 27/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Cardiac disorders ATRIAL FIBRILLATION	5.6% 42/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	6.2% 30/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Blood and lymphatic system disorders ANAEMIA	5.5% 41/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.2% 25/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
Renal and urinary disorders RENAL FAILURE CHRONIC	2.9% 22/748 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.	5.8% 28/480 • From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.

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• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
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Restriction type: OTHER