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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