age 12 Years to 65 Years
Item
Alter 12 bis 65 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male, 12 - 65 years, with body weight >= 30 kg and <= 120 kg
Item
Male, 12 - 65 years, with body weight >= 30 kg and <= 120 kg
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
Documented severe Hemophilia B (FIX activity of <= 2%) or tested by the central laboratory at screening
Item
Documented severe Hemophilia B (FIX activity of <= 2%) or tested by the central laboratory at screening
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0008533 (UMLS CUI 2011AA)
41788008 (SNOMED CT 2011_0131)
10016077 (MedDRA 14.1)
D67 (ICD-10-CM Version 2010)
286.1 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0368934 (UMLS CUI 2011AA)
MTHU014834 (LOINC Version 232)
C0871311 (UMLS CUI 2011AA)
10072089 (MedDRA 14.1)
Subjects who have received FIX products for > 150 exposure days (EDs) (estimated)
Item
Subjects who have received FIX products for > 150 exposure days (EDs) (estimated)
boolean
C1514756 (UMLS CUI 2011AA)
C0015491 (UMLS CUI 2011AA)
424562004 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
No confirmed prior history of FIX inhibitor (history of positive FIX inhibitor defined as two consecutive positive tests - a confirmatory test on a second, separately drawn sample shortly after the previous positive test) and confirmed no detectable FIX inhibitors (negative FIX inhibitor defined as < 0.6 Bethesda Units [BU] by the central laboratory at screening
Item
No confirmed prior history of FIX inhibitor (history of positive FIX inhibitor defined as two consecutive positive tests - a confirmatory test on a second, separately drawn sample shortly after the previous positive test) and confirmed no detectable FIX inhibitors (negative FIX inhibitor defined as < 0.6 Bethesda Units [BU] by the central laboratory at screening
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C1335447 (UMLS CUI 2011AA)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
CL415098 (UMLS CUI 2011AA)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Subjects can be treated on-demand or under prophylactic therapy
Item
Subjects can be treated on-demand or under prophylactic therapy
boolean
C0679686 (UMLS CUI 2011AA)
C0445202 (UMLS CUI 2011AA)
262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C0039798 (UMLS CUI 2011AA)
Signed Informed Consent/Assent
Item
Signed Informed Consent/Assent
boolean
C0021430 (UMLS CUI 2011AA)
Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein
Item
Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0002792 (UMLS CUI 2011AA)
39579001 (SNOMED CT 2011_0131)
10002199 (MedDRA 14.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE 1105E)
C0015491 (UMLS CUI 2011AA)
424562004 (SNOMED CT 2011_0131)
C0018557 (UMLS CUI 2011AA)
392390005 (SNOMED CT 2011_0131)
C0033684 (UMLS CUI 2011AA)
88878007 (SNOMED CT 2011_0131)
MTHU001951 (LOINC Version 232)
Any known congenital or acquired coagulation disorder other than congenital FIX deficiency
Item
Any known congenital or acquired coagulation disorder other than congenital FIX deficiency
boolean
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
C0398622 (UMLS CUI 2011AA)
234466008 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0008533 (UMLS CUI 2011AA)
41788008 (SNOMED CT 2011_0131)
10016077 (MedDRA 14.1)
D67 (ICD-10-CM Version 2010)
286.1 (ICD-9-CM Version 2011)
Platelet count < 100,000/microL
Item
Thrombozyten
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Immunocompromised (CD4 count < 200/mm3), (HIV positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the Investigator)
Item
Immunocompromised (CD4 count < 200/mm3), (HIV positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the Investigator)
boolean
C0085393 (UMLS CUI 2011AA)
370388006 (SNOMED CT 2011_0131)
C1277776 (UMLS CUI 2011AA)
313660005 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0033607 (UMLS CUI 2011AA)
412127001 (SNOMED CT 2011_0131)
C2363964 (UMLS CUI 2011AA)
10068724 (MedDRA 14.1)
Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment
Item
Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment
boolean
C1514756 (UMLS CUI 2011AA)
C0005525 (UMLS CUI 2011AA)
C0021027 (UMLS CUI 2011AA)
399771004 (SNOMED CT 2011_0131)
14 (HL7 V3 2006_05)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration > 5 times (x) the upper limit of normal (ULN)
Item
Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration > 5 times (x) the upper limit of normal (ULN)
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Serum creatinine > 2 x ULN
Item
Serum creatinine > 2 x ULN
boolean
C0201976 (UMLS CUI 2011AA)
Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment
Item
Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment
boolean
C0040053 (UMLS CUI 2011AA)
439127006 (SNOMED CT 2011_0131)
10043607 (MedDRA 14.1)
C0149871 (UMLS CUI 2011AA)
128053003 (SNOMED CT 2011_0131)
10051055 (MedDRA 14.1)
I82.40 (ICD-10-CM Version 2010)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0549124 (UMLS CUI 2011AA)
54687002 (SNOMED CT 2011_0131)
10014513 (MedDRA 14.1)
Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration
Item
Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1514798 (UMLS CUI 2011AA)
C0015491 (UMLS CUI 2011AA)
54378000 (SNOMED CT 2011_0131)
C0162768 (UMLS CUI 2011AA)
422055000 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry
Item
Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry
boolean
C2826244 (UMLS CUI 2011AA)
C1970394 (UMLS CUI 2011AA)
C0679637 (UMLS CUI 2011AA)
C0162439 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Subject currently on a dose and/or regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the PK sampling period
Item
Subject currently on a dose and/or regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the PK sampling period
boolean
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C0015491 (UMLS CUI 2011AA)
54378000 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance
Item
Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0023015 (UMLS CUI 2011AA)
62305002 (SNOMED CT 2011_0131)
F80.9 (ICD-10-CM Version 2010)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0496735 (UMLS CUI 2011AA)