A Study of Intravenous Mircera for the Treatment of Anemi... | NCT00077610

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RO0503821 (1x/2 Weeks)	Experimental	Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.	Drug: RO0503821 (1x/2 Weeks)
RO0503821 (1x/4 Weeks)	Experimental	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.	Drug: RO0503821 (1x/4 Weeks)
Epoetin (1-3x/Weeks)	Active Comparator	Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.	Drug: Epoetin alfa or beta

Name	Type	Description	Arm Group Labels	Other Names
Epoetin alfa or beta	Drug	intravenously 3 times weekly for 52 weeks, as prescribed	Epoetin (1-3x/Weeks)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period	A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.	Baseline, Week 29 to Week 36

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.	The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35211	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36791280	Derived	Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
17950856	Derived	Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. doi: 10.1016/S0140-6736(07)61599-2.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
BG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
BG002	Epoetin (1-3x/Weeks)	Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-0.10± 1.06 OG0010.01± 0.96 OG002-0.10± 0.92

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.	ANCOVA, CI for difference between groups		<0.0001		Mean Difference between groups	0.004	Standard Error of the Mean	0.0973	2-Sided	97.5	-0.215	0.223			Difference between groups based on the adjusted means derived from the ANCOVA model	Yes	Non-Inferiority or Equivalence	The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.

Secondary

Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.

The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.

The intent-to-treat (ITT) population was defined as all randomized participants. At the end of Week 36, data allowing the evaluation of the therapeutic response was available for 196/221, 188/220, and 205/225 participants in RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks), and Epoetin (1 -3x/Weeks), respectively.

Posted

Number

participants

Baseline, Week 29 to Week 36

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.

Secondary

The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods

The number of participants who received RBC transfusions during the titration and evaluation periods were reported .

The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.

Posted

Number

participants

Week 1 to Week 36

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG002	Epoetin (1-3x/Weeks)	Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks

Secondary

Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)

The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).

Posted

Number

participants

Up to Week 53

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.

Secondary

Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes

Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L

Posted

Number

participants

Up to Week 53

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.

Secondary

Mean Change in Blood Pressure From Baseline at Week 36 and Week 52

Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).

Posted

Mean

Standard Deviation

millimeter of mercury (mmHg)

Baseline, Week 36 and Week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.

Secondary

Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52

Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period.

Posted

Mean

Standard Deviation

beats per minute (bpm)

Baseline, Week 36 and Week 52

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG002	Epoetin (1-3x/Weeks)

Secondary

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.

Posted

Number

participants

Upto Week 53

ID	Title	Description
OG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
OG001	RO0503821 (1x/4 Weeks)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RO0503821 (1x/2 Weeks)	Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.	101	221	166	221
EG001	RO0503821 (1x/4 Weeks)	Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.	87	220	151	220
EG002	Epoetin (1-3x/Weeks)	Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.	99	225	175	225

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0005 affected221 at risk EG0016 affected220 at risk EG0029 affected225 at risk
Pneumonia	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0009 affected221 at risk EG0015 affected220 at risk EG0025 affected225 at risk
Cellulitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0003 affected221 at risk EG0011 affected220 at risk EG0024 affected225 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0013 affected220 at risk EG0022 affected225 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0013 affected220 at risk EG0021 affected225 at risk
Gangrene	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0023 affected225 at risk
Septic shock	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0012 affected220 at risk EG0022 affected225 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Bacteraemia	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Urosepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0013 affected220 at risk EG0020 affected225 at risk
Catheter sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Clostridium colitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Diverticulitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Lobar pneumonia	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Urinary tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0012 affected220 at risk EG0020 affected225 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Abdominal abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Arteriovenous graft site abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Biliary sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Bronchitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Bronchitis acute viral	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Catheter related infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Endocarditis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Escherichia infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Gastroenteritis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Groin abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Influenza	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Osteomyelitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Postoperative infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Postoperative wound infection	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Pyelonephritis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Sepsis syndrome	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Splenic abscess	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0006 affected221 at risk EG0013 affected220 at risk EG0027 affected225 at risk
Myocardial infarction	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0003 affected221 at risk EG0013 affected220 at risk EG0027 affected225 at risk
Cardiac arrest	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0008 affected221 at risk EG0012 affected220 at risk EG0022 affected225 at risk
Cardio respiratory arrest	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0003 affected221 at risk EG0012 affected220 at risk EG0023 affected225 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0003 affected221 at risk EG0012 affected220 at risk EG0022 affected225 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0014 affected220 at risk EG0021 affected225 at risk
Coronary artery disease	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0003 affected221 at risk EG0010 affected220 at risk EG0023 affected225 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0013 affected220 at risk EG0021 affected225 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Angina pectoris	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Atrial flutter	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Angina unstable	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Bradycardia	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Aortic valve calcification	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Arrhythmia	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Cardiac failure	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Palpitations	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Pericardial effusion	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Right ventricular failure	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Tachycardia	Cardiac disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0018 affected220 at risk EG0027 affected225 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0014 affected220 at risk EG0024 affected225 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0022 affected225 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0012 affected220 at risk EG0020 affected225 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0012 affected220 at risk EG0020 affected225 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Colitis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Gastritis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Intestinal infarction	Endocrine disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Vomiting	Gastrointestinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0005 affected221 at risk EG0014 affected220 at risk EG0024 affected225 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0025 affected225 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0012 affected220 at risk EG0023 affected225 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0012 affected220 at risk EG0022 affected225 at risk
Hypertensive crisis	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0022 affected225 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0013 affected220 at risk EG0021 affected225 at risk
Hypertension	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Hypotension	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Venous stenosis	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Air embolism	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Aneurysm arteriovenous	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Aortic aneurysm	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Extremity necrosis	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Haematoma	Pregnancy, puerperium and perinatal conditions	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Hypoperfusion	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Thrombosis	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Vascular pseudoaneurysm	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Venous thrombosis	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Wound haemorrhage	Vascular disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Syncope	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0012 affected220 at risk EG0022 affected225 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Cerebral thrombosis	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0013 affected220 at risk EG0020 affected225 at risk
Dementia	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Benign intracranial hypertension	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Brain stem infarction	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Cerebral infarction	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Complex partial seizures	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Dizziness	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Migraine	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Nervous system disorder	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Syncope vasovagal	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Chest pain	General disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0012 affected220 at risk EG0027 affected225 at risk
Non-cardiac chest pain	General disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0022 affected225 at risk
Multi-organ failure	General disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Pyrexia	General disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Sudden death	General disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0012 affected220 at risk EG0020 affected225 at risk
Catheter related complication	General disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Catheter site haemorrhage	General disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Hyperpyrexia	General disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Hypothermia	General disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Influenza like illness	General disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Sudden cardiac death	General disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0012 affected220 at risk EG0021 affected225 at risk
Intervertebral discitis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Bursa disorder	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0013 affected220 at risk EG0022 affected225 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0003 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment	EG0004 affected221 at risk EG0011 affected220 at risk EG0027 affected225 at risk
Haematuria	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Renal disorder	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Renal failure	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Mental status changes	Psychiatric disorders	MedDRA 8.1	Systematic Assessment	EG0002 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Confusional state	Psychiatric disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0021 affected225 at risk
Hypomania	Psychiatric disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Diabetic dermopathy	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Hypersensitivity	Immune system disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0012 affected220 at risk EG0020 affected225 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0022 affected225 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Angle closure glaucoma	Eye disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Blindness transient	Eye disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Glaucoma	Eye disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Retinal haemorrhage	Eye disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Female genital-digestive tract fistula	Reproductive system and breast disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Gastrointestinal angiodysplasia	Congenital, familial and genetic disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Vestibular neuronitis	Ear and labyrinth disorders	MedDRA 8.1	Systematic Assessment	EG0001 affected221 at risk EG0010 affected220 at risk EG0020 affected225 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0011 affected220 at risk EG0020 affected225 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 8.1	Systematic Assessment	EG0000 affected221 at risk EG0010 affected220 at risk EG0021 affected225 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA Ver 8.1	Systematic Assessment	EG00024 affected221 at risk EG00123 affected220 at risk EG00228 affected225 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Ver 8.1	Systematic Assessment	EG00015 affected221 at risk EG00119 affected220 at risk EG00215 affected225 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA Ver 8.1	Systematic Assessment	EG00018 affected221 at risk EG00120 affected220 at risk EG0029 affected225 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA Ver 8.1	Systematic Assessment	EG00016 affected221 at risk EG00110 affected220 at risk EG00215 affected225 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA Ver 8.1	Systematic Assessment	EG0008 affected221 at risk EG00113 affected220 at risk EG00213 affected225 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA Ver 8.1	Systematic Assessment	EG0009 affected221 at risk EG0018 affected220 at risk EG00215 affected225 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA Ver 8.1	Systematic Assessment	EG00012 affected221 at risk EG0017 affected220 at risk EG0024 affected225 at risk
Nasopharyngitis	Infections and infestations	MedDRA Ver 8.1	Systematic Assessment	EG00028 affected221 at risk EG00139 affected220 at risk EG00224 affected225 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Ver 8.1	Systematic Assessment	EG00020 affected221 at risk EG00130 affected220 at risk EG00225 affected225 at risk
Urinary tract infection	Infections and infestations	MedDRA Ver 8.1	Systematic Assessment	EG00013 affected221 at risk EG00112 affected220 at risk EG0029 affected225 at risk
Gastroenteritis	Infections and infestations	MedDRA Ver 8.1	Systematic Assessment	EG0006 affected221 at risk EG00111 affected220 at risk EG0023 affected225 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Ver 8.1	Systematic Assessment	EG00019 affected221 at risk EG00119 affected220 at risk EG00224 affected225 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Ver 8.1	Systematic Assessment	EG00019 affected221 at risk EG00111 affected220 at risk EG00218 affected225 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Ver 8.1	Systematic Assessment	EG00019 affected221 at risk EG00115 affected220 at risk EG00212 affected225 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Ver 8.1	Systematic Assessment	EG00011 affected221 at risk EG0013 affected220 at risk EG00212 affected225 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Ver 8.1	Systematic Assessment	EG00037 affected221 at risk EG00125 affected220 at risk EG00230 affected225 at risk
Vomiting	Gastrointestinal disorders	MedDRA Ver 8.1	Systematic Assessment	EG00016 affected221 at risk EG00111 affected220 at risk EG00214 affected225 at risk
Nausea	Gastrointestinal disorders	MedDRA Ver 8.1	Systematic Assessment	EG00010 affected221 at risk EG0019 affected220 at risk EG00215 affected225 at risk
Constipation	Gastrointestinal disorders	MedDRA Ver 8.1	Systematic Assessment	EG00012 affected221 at risk EG0014 affected220 at risk EG00212 affected225 at risk
Headache	Nervous system disorders	MedDRA Ver 8.1	Systematic Assessment	EG00030 affected221 at risk EG00117 affected220 at risk EG00224 affected225 at risk
Dizziness	Nervous system disorders	MedDRA Ver 8.1	Systematic Assessment	EG0006 affected221 at risk EG00113 affected220 at risk EG00212 affected225 at risk
Pyrexia	General disorders	MedDRA Ver 8.1	Systematic Assessment	EG0008 affected221 at risk EG0018 affected220 at risk EG00217 affected225 at risk
Asthenia	General disorders	MedDRA Ver 8.1	Systematic Assessment	EG00011 affected221 at risk EG00115 affected220 at risk EG0026 affected225 at risk
Fatigue	General disorders	MedDRA Ver 8.1	Systematic Assessment	EG00012 affected221 at risk EG0019 affected220 at risk EG0026 affected225 at risk
Hypertension	Vascular disorders	MedDRA Ver 8.1	Systematic Assessment	EG00022 affected221 at risk EG00128 affected220 at risk EG00234 affected225 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Ver 8.1	Systematic Assessment	EG00020 affected221 at risk EG00119 affected220 at risk EG00218 affected225 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Ver 8.1	Systematic Assessment	EG0008 affected221 at risk EG0019 affected220 at risk EG00215 affected225 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA Ver 8.1	Systematic Assessment	EG00023 affected221 at risk EG00118 affected220 at risk EG00213 affected225 at risk
Insomnia	Psychiatric disorders	MedDRA Ver 8.1	Systematic Assessment	EG00011 affected221 at risk EG00114 affected220 at risk EG00214 affected225 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Ver 8.1	Systematic Assessment	EG00011 affected221 at risk EG00111 affected220 at risk EG00214 affected225 at risk

Ancestor Terms

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

Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose administered during the week preceding the switch to the study drug.

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D000068817	Epoetin Alfa
D004921	Erythropoietin
C508420	continuous erythropoietin receptor activator