ID

43423

Description

ODM derived from http://clinicaltrials.gov/show/NCT00701714

Link

http://clinicaltrials.gov/show/NCT00701714

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00701714 Anemia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Known chronic renal insufficiency of at least 4 weeks duration. CKD stage at least 3 or higher
Description

Known chronic renal insufficiency of at least 4 weeks duration. CKD stage at least 3 or higher

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0403447
SNOMED CT 2011_0131
236425005
MedDRA 14.1
10050441
CTCAE 1105E
E12988
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
UMLS CUI 2011AA
C2316787
SNOMED CT 2011_0131
433144002
UMLS CUI 2011AA
C2317473
SNOMED CT 2011_0131
431857002
UMLS CUI 2011AA
C2316810
SNOMED CT 2011_0131
433146000
ICD-10-CM Version 2010
N18.5
Patients who are naive to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.)
Description

Patients who are naive to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.)

Data type

boolean

Alias
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
C0919936
MedDRA 14.1
10051259
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
C1948053
UMLS CUI 2011AA
C0348016
SNOMED CT 2011_0131
255560000
UMLS CUI 2011AA
C1522438
SNOMED CT 2011_0131
34206005
HL7 V3 2006_05
SubcutaneousRoute
Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period
Description

Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period

Data type

boolean

Alias
UMLS CUI 2011AA
C0002871
Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20%
Description

Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20%

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0302583
SNOMED CT 2011_0131
3829006
LOINC Version 232
MTHU004837
UMLS CUI 2011AA
C0449438
SNOMED CT 2011_0131
263490005
LOINC Version 232
MTHU015827
UMLS CUI 2011AA
C0696113
SNOMED CT 2011_0131
269821003
MedDRA 14.1
10040246
UMLS CUI 2011AA
C0202105
SNOMED CT 2011_0131
359982005
MedDRA 14.1
10044354
UMLS CUI 2011AA
C0522534
SNOMED CT 2011_0131
103401005
Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration
Description

Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1719822
SNOMED CT 2011_0131
421939007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0302828
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1522438
SNOMED CT 2011_0131
34206005
HL7 V3 2006_05
SubcutaneousRoute
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
Written informed consent of the patient.
Description

Written informed consent of the patient.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Anemia of non-renal causes
Description

Anemia of non-renal causes

Data type

boolean

Alias
UMLS CUI 2011AA
C0002871
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis)
Description

Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis)

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
UMLS CUI 2011AA
C0040739
UMLS CUI 2011AA
C0444498
SNOMED CT 2011_0131
264031007
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0409974
SNOMED CT 2011_0131
200936003
MedDRA 14.1
10025134
ICD-10-CM Version 2010
L93
ICD-9-CM Version 2011
695.4
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis)
Description

Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
108241001
MedDRA 14.1
10061105
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1883016
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
108241001
MedDRA 14.1
10061105
Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment
Description

Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0868945
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0205390
SNOMED CT 2011_0131
21191007
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
Patients receiving any RBC/whole blood transfusion during the screening period
Description

Patients receiving any RBC/whole blood transfusion during the screening period

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0086252
SNOMED CT 2011_0131
116863004
UMLS CUI 2011AA
C0199961
SNOMED CT 2011_0131
33389009
MedDRA 14.1
10047973
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1948053
Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
Description

Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)

Data type

boolean

Alias
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C3463824
SNOMED CT 2011_0131
128623006
MedDRA 14.1
10028533
ICD-10-CM Version 2010
D46
ICD-9-CM Version 2011
238.75
CTCAE 1105E
E12552
UMLS CUI 2011AA
C0002895
SNOMED CT 2011_0131
127040003
MedDRA 14.1
10040641
LOINC Version 232
MTHU021603
ICD-10-CM Version 2010
D57.1
ICD-9-CM Version 2011
282.6
UMLS CUI 2011AA
C0376545
SNOMED CT 2011_0131
129154003
MedDRA 14.1
10066476
UMLS CUI 2011AA
C0002878
SNOMED CT 2011_0131
61261009
MedDRA 14.1
10018916
ICD-10-CM Version 2010
D55-D59
Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2)
Description

Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2)

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range. Or gamma-GT above 3x upper limit of normal range)
Description

Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range. Or gamma-GT above 3x upper limit of normal range)

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C1948050
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1514721
UMLS CUI 2011AA
C0017040
SNOMED CT 2011_0131
60153001
LOINC Version 232
MTHU001941
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C1632851
SNOMED CT 2011_0131
417929005
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1514721
Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -2.
Description

Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -2.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0020502
SNOMED CT 2011_0131
66999008
MedDRA 14.1
10020705
ICD-10-CM Version 2010
E21.3
ICD-9-CM Version 2011
252.00
CTCAE 1105E
E10319
UMLS CUI 2011AA
C0030520
SNOMED CT 2011_0131
4076007
LOINC Version 232
MTHU005026
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements)
Description

Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements)

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C1306620
MedDRA 14.1
10005756
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
UMLS CUI 2011AA
C0242485
SNOMED CT 2011_0131
122869004
LOINC Version 232
MTHU003137
UMLS CUI 2011AA
C1510992
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1522609
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
CL426201
UMLS CUI 2011AA
C0242485
SNOMED CT 2011_0131
122869004
LOINC Version 232
MTHU003137
Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV]
Description

Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV]

Data type

boolean

Alias
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
History of stroke or myocardial infarction during the last 6 months prior to visit -2
Description

History of stroke or myocardial infarction during the last 6 months prior to visit -2

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C1275835
SNOMED CT 2011_0131
399211009
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Ongoing treatment with phenprocoumon or other cumarin derivates
Description

Ongoing treatment with phenprocoumon or other cumarin derivates

Data type

boolean

Alias
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0031444
SNOMED CT 2011_0131
59488002
LOINC Version 232
MTHU016364
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0010206
SNOMED CT 2011_0131
373307003
UMLS CUI 2011AA
C0243072
Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL)
Description

Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL)

Data type

boolean

Alias
UMLS CUI 2011AA
C0040034
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0023530
SNOMED CT 2011_0131
84828003
MedDRA 14.1
10024384
ICD-10-CM Version 2010
D72.819
ICD-9-CM Version 2011
288.50
CTCAE 1105E
E12232
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis
Description

Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis

Data type

boolean

Alias
UMLS CUI 2011AA
C0017181
SNOMED CT 2011_0131
74474003
MedDRA 14.1
10017955
ICD-10-CM Version 2010
K92.2
ICD-9-CM Version 2011
578
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C2945560
SNOMED CT 2011_0131
73320003
Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L
Description

Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0275518
SNOMED CT 2011_0131
63171007
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0201657
SNOMED CT 2011_0131
55235003
MedDRA 14.1
10006824
UMLS CUI 2011AA
C1522609
Suspicion or known PRCA (pure red cell aplasia)
Description

Suspicion or known PRCA (pure red cell aplasia)

Data type

boolean

Alias
UMLS CUI 2011AA
C0242114
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0034902
SNOMED CT 2011_0131
50715003
MedDRA 14.1
10002965
Previously diagnosed HIV or acute hepatitis infection
Description

Previously diagnosed HIV or acute hepatitis infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0332132
SNOMED CT 2011_0131
48318009
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C0019158
SNOMED CT 2011_0131
29001004
MedDRA 14.1
10019717
UMLS CUI 2011AA
C0275518
SNOMED CT 2011_0131
63171007
History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening
Description

History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery)
Description

Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery)

Data type

boolean

Alias
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C0205250
SNOMED CT 2011_0131
75540009
UMLS CUI 2011AA
CL353706
UMLS CUI 2011AA
CL414352
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0441510
UMLS CUI 2011AA
C1278494
SNOMED CT 2011_0131
314774003
Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer)
Description

Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner)
Description

Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner)

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Known history of severe drug related allergies (e.g. anaphylactic shock)
Description

Known history of severe drug related allergies (e.g. anaphylactic shock)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0013182
LOINC Version 232
MTHU002637
UMLS CUI 2011AA
C0002792
SNOMED CT 2011_0131
39579001
MedDRA 14.1
10002199
ICD-10-CM Version 2010
T78.2
CTCAE 1105E
E11254
Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products
Description

Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
CL414967
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0024660
SNOMED CT 2011_0131
387976007
UMLS CUI 2011AA
C1441547
UMLS CUI 2011AA
C1514468
Known or suspicion of any non-compliance with respect to subcutaneous treatment
Description

Known or suspicion of any non-compliance with respect to subcutaneous treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0242114
UMLS CUI 2011AA
C0231347
SNOMED CT 2011_0131
45704003
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
C1522438
SNOMED CT 2011_0131
34206005
HL7 V3 2006_05
SubcutaneousRoute
UMLS CUI 2011AA
C0039798
Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study
Description

Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Participation in another ESA study in the 3 months preceding visit -2
Description

Participation in another ESA study in the 3 months preceding visit -2

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.
Description

Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Known chronic renal insufficiency of at least 4 weeks duration. CKD stage at least 3 or higher
Item
Known chronic renal insufficiency of at least 4 weeks duration. CKD stage at least 3 or higher
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0403447 (UMLS CUI 2011AA)
236425005 (SNOMED CT 2011_0131)
10050441 (MedDRA 14.1)
E12988 (CTCAE 1105E)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C2316787 (UMLS CUI 2011AA)
433144002 (SNOMED CT 2011_0131)
C2317473 (UMLS CUI 2011AA)
431857002 (SNOMED CT 2011_0131)
C2316810 (UMLS CUI 2011AA)
433146000 (SNOMED CT 2011_0131)
N18.5 (ICD-10-CM Version 2010)
Patients who are naive to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.)
Item
Patients who are naive to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.)
boolean
C2917382 (UMLS CUI 2011AA)
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C2917382 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C2917382 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
C0348016 (UMLS CUI 2011AA)
255560000 (SNOMED CT 2011_0131)
C1522438 (UMLS CUI 2011AA)
34206005 (SNOMED CT 2011_0131)
SubcutaneousRoute (HL7 V3 2006_05)
Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period
Item
Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period
boolean
C0002871 (UMLS CUI 2011AA)
Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20%
Item
Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20%
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0302583 (UMLS CUI 2011AA)
3829006 (SNOMED CT 2011_0131)
MTHU004837 (LOINC Version 232)
C0449438 (UMLS CUI 2011AA)
263490005 (SNOMED CT 2011_0131)
MTHU015827 (LOINC Version 232)
C0696113 (UMLS CUI 2011AA)
269821003 (SNOMED CT 2011_0131)
10040246 (MedDRA 14.1)
C0202105 (UMLS CUI 2011AA)
359982005 (SNOMED CT 2011_0131)
10044354 (MedDRA 14.1)
C0522534 (UMLS CUI 2011AA)
103401005 (SNOMED CT 2011_0131)
Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration
Item
Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1719822 (UMLS CUI 2011AA)
421939007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0302828 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C1514873 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1522438 (UMLS CUI 2011AA)
34206005 (SNOMED CT 2011_0131)
SubcutaneousRoute (HL7 V3 2006_05)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
Written informed consent of the patient.
Item
Written informed consent of the patient.
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Anemia of non-renal causes
Item
Anemia of non-renal causes
boolean
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
C1518422 (UMLS CUI 2011AA)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis)
Item
Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis)
boolean
C0039798 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C0040739 (UMLS CUI 2011AA)
C0444498 (UMLS CUI 2011AA)
264031007 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0409974 (UMLS CUI 2011AA)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis)
Item
Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis)
boolean
C1514463 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
C1517741 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1883016 (UMLS CUI 2011AA)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment
Item
Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0868945 (UMLS CUI 2011AA)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0205390 (UMLS CUI 2011AA)
21191007 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
Patients receiving any RBC/whole blood transfusion during the screening period
Item
Patients receiving any RBC/whole blood transfusion during the screening period
boolean
C1514756 (UMLS CUI 2011AA)
C0086252 (UMLS CUI 2011AA)
116863004 (SNOMED CT 2011_0131)
C0199961 (UMLS CUI 2011AA)
33389009 (SNOMED CT 2011_0131)
10047973 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
Item
Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
boolean
CL414904 (UMLS CUI 2011AA)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
CL324441 (UMLS CUI 2011AA)
C3463824 (UMLS CUI 2011AA)
128623006 (SNOMED CT 2011_0131)
10028533 (MedDRA 14.1)
D46 (ICD-10-CM Version 2010)
238.75 (ICD-9-CM Version 2011)
E12552 (CTCAE 1105E)
C0002895 (UMLS CUI 2011AA)
127040003 (SNOMED CT 2011_0131)
10040641 (MedDRA 14.1)
MTHU021603 (LOINC Version 232)
D57.1 (ICD-10-CM Version 2010)
282.6 (ICD-9-CM Version 2011)
C0376545 (UMLS CUI 2011AA)
129154003 (SNOMED CT 2011_0131)
10066476 (MedDRA 14.1)
C0002878 (UMLS CUI 2011AA)
61261009 (SNOMED CT 2011_0131)
10018916 (MedDRA 14.1)
D55-D59 (ICD-10-CM Version 2010)
Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2)
Item
Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2)
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range. Or gamma-GT above 3x upper limit of normal range)
Item
Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range. Or gamma-GT above 3x upper limit of normal range)
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
CL384738 (UMLS CUI 2011AA)
C1948050 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
C1514721 (UMLS CUI 2011AA)
C0017040 (UMLS CUI 2011AA)
60153001 (SNOMED CT 2011_0131)
MTHU001941 (LOINC Version 232)
CL384738 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C1632851 (UMLS CUI 2011AA)
417929005 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
C1514721 (UMLS CUI 2011AA)
Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -2.
Item
Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -2.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0020502 (UMLS CUI 2011AA)
66999008 (SNOMED CT 2011_0131)
10020705 (MedDRA 14.1)
E21.3 (ICD-10-CM Version 2010)
252.00 (ICD-9-CM Version 2011)
E10319 (CTCAE 1105E)
C0030520 (UMLS CUI 2011AA)
4076007 (SNOMED CT 2011_0131)
MTHU005026 (LOINC Version 232)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements)
Item
Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements)
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C1306620 (UMLS CUI 2011AA)
10005756 (MedDRA 14.1)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
C1510992 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1522609 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
CL426201 (UMLS CUI 2011AA)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV]
Item
Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV]
boolean
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
History of stroke or myocardial infarction during the last 6 months prior to visit -2
Item
History of stroke or myocardial infarction during the last 6 months prior to visit -2
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Ongoing treatment with phenprocoumon or other cumarin derivates
Item
Ongoing treatment with phenprocoumon or other cumarin derivates
boolean
C0549178 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0031444 (UMLS CUI 2011AA)
59488002 (SNOMED CT 2011_0131)
MTHU016364 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0010206 (UMLS CUI 2011AA)
373307003 (SNOMED CT 2011_0131)
C0243072 (UMLS CUI 2011AA)
Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL)
Item
Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL)
boolean
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0023530 (UMLS CUI 2011AA)
84828003 (SNOMED CT 2011_0131)
10024384 (MedDRA 14.1)
D72.819 (ICD-10-CM Version 2010)
288.50 (ICD-9-CM Version 2011)
E12232 (CTCAE 1105E)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis
Item
Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis
boolean
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
C1517741 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C2945560 (UMLS CUI 2011AA)
73320003 (SNOMED CT 2011_0131)
Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L
Item
Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0275518 (UMLS CUI 2011AA)
63171007 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0201657 (UMLS CUI 2011AA)
55235003 (SNOMED CT 2011_0131)
10006824 (MedDRA 14.1)
C1522609 (UMLS CUI 2011AA)
Suspicion or known PRCA (pure red cell aplasia)
Item
Suspicion or known PRCA (pure red cell aplasia)
boolean
C0242114 (UMLS CUI 2011AA)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0034902 (UMLS CUI 2011AA)
50715003 (SNOMED CT 2011_0131)
10002965 (MedDRA 14.1)
Previously diagnosed HIV or acute hepatitis infection
Item
Previously diagnosed HIV or acute hepatitis infection
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
C0275518 (UMLS CUI 2011AA)
63171007 (SNOMED CT 2011_0131)
History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening
Item
History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C0039798 (UMLS CUI 2011AA)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery)
Item
Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery)
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
C1517001 (UMLS CUI 2011AA)
C0205250 (UMLS CUI 2011AA)
75540009 (SNOMED CT 2011_0131)
CL353706 (UMLS CUI 2011AA)
CL414352 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
CL414906 (UMLS CUI 2011AA)
C0679637 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0441510 (UMLS CUI 2011AA)
C1278494 (UMLS CUI 2011AA)
314774003 (SNOMED CT 2011_0131)
Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer)
Item
Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1517741 (UMLS CUI 2011AA)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner)
Item
Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner)
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
CL414906 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Known history of severe drug related allergies (e.g. anaphylactic shock)
Item
Known history of severe drug related allergies (e.g. anaphylactic shock)
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0013182 (UMLS CUI 2011AA)
MTHU002637 (LOINC Version 232)
C0002792 (UMLS CUI 2011AA)
39579001 (SNOMED CT 2011_0131)
10002199 (MedDRA 14.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE 1105E)
Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products
Item
Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
CL414967 (UMLS CUI 2011AA)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0024660 (UMLS CUI 2011AA)
387976007 (SNOMED CT 2011_0131)
C1441547 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
Known or suspicion of any non-compliance with respect to subcutaneous treatment
Item
Known or suspicion of any non-compliance with respect to subcutaneous treatment
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0242114 (UMLS CUI 2011AA)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C1522438 (UMLS CUI 2011AA)
34206005 (SNOMED CT 2011_0131)
SubcutaneousRoute (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study
Item
Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study
boolean
C2348568 (UMLS CUI 2011AA)
Participation in another ESA study in the 3 months preceding visit -2
Item
Participation in another ESA study in the 3 months preceding visit -2
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2917382 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.
Item
Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
CL102947 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
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