age 12 Years to 65 Years
Item
Alter 12 bis 65 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subject is 12 to 65 years old at the time of screening
Item
Subject is 12 to 65 years old at the time of screening
boolean
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Subject and/or legal representative has/have provided signed informed consent
Item
Subject and/or legal representative has/have provided signed informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Subject has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level <= 2%) hemophilia B (based on the one stage activated partial thromboplastin time [aPTT] assay), as tested at screening at the central laboratory
Item
Subject has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level <= 2%) hemophilia B (based on the one stage activated partial thromboplastin time [aPTT] assay), as tested at screening at the central laboratory
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1299393 (UMLS CUI 2011AA)
371924009 (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)
C0200408 (UMLS CUI 2011AA)
78882004 (SNOMED CT 2011_0131)
10009744 (MedDRA 14.1)
C1705938 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
Subject is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs)(based on the subject's medical records)
Item
Subject is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs)(based on the subject's medical records)
boolean
C1514463 (UMLS CUI 2011AA)
C2964352 (UMLS CUI 2011AA)
MTHU036409 (LOINC Version 232)
C1514798 (UMLS CUI 2011AA)
C0360726 (UMLS CUI 2011AA)
346428009 (SNOMED CT 2011_0131)
C1524031 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
Subject has no evidence of a history of FIX inhibitors (based on the subject's medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment.
Item
Subject has no evidence of a history of FIX inhibitors (based on the subject's medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment.
boolean
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
The subject has a history of FIX inhibitors with a titer >= 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening
Item
The subject has a history of FIX inhibitors with a titer >= 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
C0475208 (UMLS CUI 2011AA)
118590008 (SNOMED CT 2011_0131)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
The subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
Item
The subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
boolean
C1511790 (UMLS CUI 2011AA)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0475208 (UMLS CUI 2011AA)
118590008 (SNOMED CT 2011_0131)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
The subject's weight is < 35 kg or > 120 kg
Item
Gewicht anomal
boolean
C0332543 (UMLS CUI 2011AA)
22495007 (SNOMED CT 2011_0131)
10056814 (MedDRA 14.1)
The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)
Item
The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
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)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0360726 (UMLS CUI 2011AA)
346428009 (SNOMED CT 2011_0131)
The subject has a known hypersensitivity to hamster proteins or rFurin
Item
The subject has a known hypersensitivity to hamster proteins or rFurin
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0018557 (UMLS CUI 2011AA)
392390005 (SNOMED CT 2011_0131)
C0033684 (UMLS CUI 2011AA)
88878007 (SNOMED CT 2011_0131)
MTHU001951 (LOINC Version 232)
C1514798 (UMLS CUI 2011AA)
C0287990 (UMLS CUI 2011AA)
130632003 (SNOMED CT 2011_0131)
The subject has ongoing or recent evidence of a thrombotic disease, fibrinolysis or DIC
Item
The subject has ongoing or recent evidence of a thrombotic disease, fibrinolysis or DIC
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0040053 (UMLS CUI 2011AA)
439127006 (SNOMED CT 2011_0131)
10043607 (MedDRA 14.1)
C0016017 (UMLS CUI 2011AA)
385538006 (SNOMED CT 2011_0131)
C0012739 (UMLS CUI 2011AA)
67406007 (SNOMED CT 2011_0131)
10013442 (MedDRA 14.1)
D65 (ICD-10-CM Version 2010)
286.6 (ICD-9-CM Version 2011)
E10028 (CTCAE 1105E)