A Study of Intravenous Mircera for the Treatment of Anemi... | NCT00413894

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

Name	Type	Description	Arm Group Labels	Other Names
methoxy polyethylene glycol-epoetin beta [Mircera]	Drug	iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase		Visits 8 to 10 (Months 6 to 8)
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase		Visits 8 to 10 (Months 6 to 8)
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase	Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.	Visits 8 to 10 (Months 6 to 8)
Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase	Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.	Visits 8 to 10 (Months 6 to 8)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase		Visits 1 to 2 (Months -2 to -1)
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase		Visits 1 to 2 (Months -2 to -1)

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26965694	Derived	Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
20225992	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)	During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant's hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

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
	OG00031.7

Primary

Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase

Posted

Number

percentage of participants

Visits 8 to 10 (Months 6 to 8)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase

Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

CP; number (n) equals (=) number of participants in the specified category

Posted

Number

percentage of participants

Visits 8 to 10 (Months 6 to 8)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase

CP; n = number of participants in the specified category

Posted

Number

percentage of participants

Visits 8 to 10 (Months 6 to 8)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase

ITT Population: All participants having received at least one dose of study medication and having at least one Hb value measurement under C.E.R.A. were included.

Posted

Number

percentage of participants

Visits 1 to 2 (Months -2 to -1)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase

ITT Population

Posted

Number

percentage of participants

Visits 1 to 2 (Months -2 to -1)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase

ITT Population; n = number of participants in the specified category

Posted

Number

percentage of participants

Visits 1 to 2 (Months -2 to -1)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase

ITT Population; n = number of participants in the specified category

Posted

Number

percentage of participants

Visits 1 to 2 (Months -2 to -1)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels

Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.

Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.

ITT Population;

Posted

Number

percentage of participants

Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Secondary

Percentage of Participants With Hb Fluctuations Within Evaluation Phase

Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.

ITT population

Posted

Number

percentage of participants

Visits 8 to 10 (Months 6 to 8)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hb Fluctuations Within Screening Phase

Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.

ITT Population

Posted

Number

percentage of participants

Visits 1 to 2 (Months -2 to -1)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts

Secondary

Percentage of Participants Requiring Erythrocyte Transfusions

Safety Population (SAF): All participants who received at least one dose of study medication independent from whether they completed the study or not were included into the safety analysis.

Posted

Number

percentage of participants

Visits 1 to 10 (Months -2 to 8)

ID	Title	Description
OG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	C.E.R.A	During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant's Hb values.			174	424	173	424

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0007 affected424 at risk
Haemorrhagic Anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Angina Pectoris	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Angina Unstable	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Mitral Valve Disease	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Goitre	Endocrine disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Hyperparathyroidism Secondary	Endocrine disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Glaucoma	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Acute Abdomen	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Dental Caries	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Gastrointestinal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Intestinal Infarction	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Tooth Socket Haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Application Site Dermatitis	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cardiac Death	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Chest Pain	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Drug Withdrawal Syndrome	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
General Physical Health Deterioration	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Oedema Peripheral	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Pain	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Systemic Inflammatory Response Syndrome	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Ulcer Haemorrhage	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Abscess Jaw	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Bronchitis Viral	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Catheter Related Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cellulitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Device Related Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Erysipelas	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Gangrene	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Gastroenteritis Clostridial	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Localised Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Paronychia	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Pneumonia	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected424 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Shunt Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Urosepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Arteriovenous Fistula Site Complication	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Arteriovenous Fistula Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Arteriovenous Fistula Thrombosis	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Decompression Sickness	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Respiratory Fume Inhalation Disorder	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Shunt Aneurysm	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Shunt Blood Flow Excessive	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Shunt Malfunction	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Shunt Occlusion	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG00011 affected424 at risk
Shunt Stenosis	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Shunt Thrombosis	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0007 affected424 at risk
Vascular Bypass Dysfunction	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Arteriogram Coronary	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Blood Pressure Increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Haemoglobin Decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG00058 affected424 at risk
Reticulocyte Count Decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Fluid Retention	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Facet Joint Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cervix Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cervix Carcinoma Stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Penis Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Tongue Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Balance Disorder	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Convulsion	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Dementia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Epilepsy	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Somnolence	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Syncope	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Alcohol Withdrawal Syndrome	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Cardiac Neurosis	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Depression	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Diabetic Nephropathy	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Renal Cyst	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Renal Failure	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Renal Failure Chronic	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0008 affected424 at risk
Breast Mass	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Postmenopausal Haemorrhage	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected424 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Coronary Angioplasty	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Large Intestine Anastomosis	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Aortic Stenosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Arterial Occlusive Disease	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected424 at risk
Circulatory Collapse	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Haematoma	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Ischaemia	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected424 at risk
Shock	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Subclavian Steal Syndrome	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk
Varicose Vein	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected424 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00049 affected424 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00036 affected424 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00032 affected424 at risk
Influenza Like Illness	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00021 affected424 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00053 affected424 at risk
Bronchitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00033 affected424 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00021 affected424 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Aachen		52066	Germany

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases