age 18 Years to 60 Years
Item
Alter 18 bis 60 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subject has voluntarily given written informed consent (before conduct of any study-related procedures)
Item
Subject has voluntarily given written informed consent (before conduct of any study-related procedures)
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
The subject has hereditary type 3 VWD (<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo <= 10% and FVIII:C <20%)
Item
The subject has hereditary type 3 VWD (<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo <= 10% and FVIII:C <20%)
boolean
C1264041 (UMLS CUI 2011AA)
128108002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1264039 (UMLS CUI 2011AA)
128106003 (SNOMED CT 2011_0131)
C1282968 (UMLS CUI 2011AA)
359714009 (SNOMED CT 2011_0131)
The subject has a medical history of at least 25 exposure days to VWF/FVIII coagulation factor concentrates
Item
The subject has a medical history of at least 25 exposure days to VWF/FVIII coagulation factor concentrates
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0042971 (UMLS CUI 2011AA)
18288009 (SNOMED CT 2011_0131)
MTHU024978 (LOINC Version 232)
C0005789 (UMLS CUI 2011AA)
350475008 (SNOMED CT 2011_0131)
C2003864 (UMLS CUI 2011AA)
The subject has a Karnofsky score >= 70%
Item
Karnofsky performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
NOT APPLICABLE IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice contraception using a method of proven reliability from the day of screening until the study completion visit
Item
NOT APPLICABLE IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice contraception using a method of proven reliability from the day of screening until the study completion visit
boolean
C1518422 (UMLS CUI 2011AA)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
APPLICABLE ONLY IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice non-hormonal-based contraception using a method of proven reliability (IUD acceptable) from the day of screening until 96 hours after the last investigational drug infusion
Item
APPLICABLE ONLY IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice non-hormonal-based contraception using a method of proven reliability (IUD acceptable) from the day of screening until 96 hours after the last investigational drug infusion
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
NOT APPLICABLE IN ITALY: The subject must agree not to be on any therapy (hormone-based contraception acceptable) interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
Item
NOT APPLICABLE IN ITALY: The subject must agree not to be on any therapy (hormone-based contraception acceptable) interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
boolean
C1518422 (UMLS CUI 2011AA)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0005789 (UMLS CUI 2011AA)
350475008 (SNOMED CT 2011_0131)
C0031328 (UMLS CUI 2011AA)
C1879533 (UMLS CUI 2011AA)
CL424941 (UMLS CUI 2011AA)
APPLICABLE ONLY IN ITALY: The subject must agree not to be on any therapy interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
Item
APPLICABLE ONLY IN ITALY: The subject must agree not to be on any therapy interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0005789 (UMLS CUI 2011AA)
350475008 (SNOMED CT 2011_0131)
C0031328 (UMLS CUI 2011AA)
The subject has been diagnosed with a hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders and/or an international normalized ratio (INR) > 1.4)
Item
The subject has been diagnosed with a hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders and/or an international normalized ratio (INR) > 1.4)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0042974 (UMLS CUI 2011AA)
128105004 (SNOMED CT 2011_0131)
10047715 (MedDRA 14.1)
D68.0 (ICD-10-CM Version 2010)
286.4 (ICD-9-CM Version 2011)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0005818 (UMLS CUI 2011AA)
22716005 (SNOMED CT 2011_0131)
10035532 (MedDRA 14.1)
CL415281 (UMLS CUI 2011AA)
The subject has been diagnosed with an ADAMTS13 deficiency with < 10% ADAMTS13 activity
Item
The subject has been diagnosed with an ADAMTS13 deficiency with < 10% ADAMTS13 activity
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0389918 (UMLS CUI 2011AA)
MTHU025106 (LOINC Version 232)
CL426295 (UMLS CUI 2011AA)
C0441655 (UMLS CUI 2011AA)
257733005 (SNOMED CT 2011_0131)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
The subject has a history or presence of VWF inhibitor
Item
von-Willebrand-Faktor-Inhibitor
boolean
C0313543 (UMLS CUI 2011AA)
1914001 (SNOMED CT 2011_0131)
The subject has a history or presence of FVIII inhibitor with a titer >= 0.4 BU (by Nijmegen assay) or >= 0.6 BU (by Bethesda assay)
Item
The subject has a history or presence of FVIII inhibitor with a titer >= 0.4 BU (by Nijmegen assay) or >= 0.6 BU (by Bethesda assay)
boolean
C0368953 (UMLS CUI 2011AA)
58730008 (SNOMED CT 2011_0131)
MTHU014157 (LOINC Version 232)
C0475208 (UMLS CUI 2011AA)
118590008 (SNOMED CT 2011_0131)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
C1510438 (UMLS CUI 2011AA)
272392009 (SNOMED CT 2011_0131)
The subject has a known hypersensitivity to mouse or hamster proteins
Item
The subject has a known hypersensitivity to mouse or hamster proteins
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1334805 (UMLS CUI 2011AA)
C0018557 (UMLS CUI 2011AA)
392390005 (SNOMED CT 2011_0131)
C0033684 (UMLS CUI 2011AA)
88878007 (SNOMED CT 2011_0131)
MTHU001951 (LOINC Version 232)
The subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, food allergies or animal allergies
Item
The subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, food allergies or animal allergies
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0021053 (UMLS CUI 2011AA)
71922006 (SNOMED CT 2011_0131)
10021425 (MedDRA 14.1)
D89.9 (ICD-10-CM Version 2010)
279.9 (ICD-9-CM Version 2011)
CL411789 (UMLS CUI 2011AA)
C0348688 (UMLS CUI 2011AA)
J30.2 (ICD-10-CM Version 2010)
C0339164 (UMLS CUI 2011AA)
231855007 (SNOMED CT 2011_0131)
C0016470 (UMLS CUI 2011AA)
414285001 (SNOMED CT 2011_0131)
10016946 (MedDRA 14.1)
FALG (HL7 V3 2006_05)
C0003062 (UMLS CUI 2011AA)
387961004 (SNOMED CT 2011_0131)
ANM (HL7 V3 2006_05)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
The subject has a medical history of a thromboembolic event
Item
The subject has a medical history of a thromboembolic event
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0857496 (UMLS CUI 2011AA)
10043565 (MedDRA 14.1)
The subject is HIV positive with an absolute CD4 count < 200/mm3
Item
The subject is HIV positive with an absolute CD4 count < 200/mm3
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C1277776 (UMLS CUI 2011AA)
313660005 (SNOMED CT 2011_0131)
The subject has been diagnosed with cardiovascular disease (New York Heart Association (NYHA) classes 1-4)
Item
The subject has been diagnosed with cardiovascular disease (New York Heart Association (NYHA) classes 1-4)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1319793 (UMLS CUI 2011AA)
420300004 (SNOMED CT 2011_0131)
10064079 (MedDRA 14.1)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
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)
The subject has been diagnosed with insulin-dependent diabetes mellitus
Item
The subject has been diagnosed with insulin-dependent diabetes mellitus
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
The subject has an acute illness (e.g. influenza, flu-like syndrome, allergic rhinitis/conjunctivitis)
Item
The subject has an acute illness (e.g. influenza, flu-like syndrome, allergic rhinitis/conjunctivitis)
boolean
C0001314 (UMLS CUI 2011AA)
2704003 (SNOMED CT 2011_0131)
C0021400 (UMLS CUI 2011AA)
6142004 (SNOMED CT 2011_0131)
10022000 (MedDRA 14.1)
J11.1 (ICD-10-CM Version 2010)
487 (ICD-9-CM Version 2011)
C1558931 (UMLS CUI 2011AA)
MTHU116939 (CTCAE 1105E)
C2607914 (UMLS CUI 2011AA)
61582004 (SNOMED CT 2011_0131)
10039085 (MedDRA 14.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE 1105E)
C0009766 (UMLS CUI 2011AA)
231854006 (SNOMED CT 2011_0131)
10010744 (MedDRA 14.1)
The subject has been diagnosed with liver disease, as evidenced by, but not limited to, any of the following: serum ALT three times the upper limit of normal, hypoalbuminemia, portal vein hypertension (e.g. presence of otherwise unexplained splenomegaly, history of esophageal varices)
Item
The subject has been diagnosed with liver disease, as evidenced by, but not limited to, any of the following: serum ALT three times the upper limit of normal, hypoalbuminemia, portal vein hypertension (e.g. presence of otherwise unexplained splenomegaly, history of esophageal varices)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0239981 (UMLS CUI 2011AA)
119247004 (SNOMED CT 2011_0131)
10020942 (MedDRA 14.1)
E12310 (CTCAE 1105E)
C0020541 (UMLS CUI 2011AA)
34742003 (SNOMED CT 2011_0131)
10036200 (MedDRA 14.1)
K76.6 (ICD-10-CM Version 2010)
572.3 (ICD-9-CM Version 2011)
E11238 (CTCAE 1105E)
C0038002 (UMLS CUI 2011AA)
16294009 (SNOMED CT 2011_0131)
10041660 (MedDRA 14.1)
R16.1 (ICD-10-CM Version 2010)
789.2 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014867 (UMLS CUI 2011AA)
28670008 (SNOMED CT 2011_0131)
10030209 (MedDRA 14.1)
I85 (ICD-10-CM Version 2010)
The subject has been diagnosed with renal disease, with a serum creatinine level >= 2 mg/dL
Item
The subject has been diagnosed with renal disease, with a serum creatinine level >= 2 mg/dL
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
In the judgment of the investigator, the subject has another clinically significant concomitant disease (e.g. uncontrolled hypertension, diabetes type II) that may pose additional risks for the subject
Item
In the judgment of the investigator, the subject has another clinically significant concomitant disease (e.g. uncontrolled hypertension, diabetes type II) that may pose additional risks for the subject
boolean
C0243087 (UMLS CUI 2011AA)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
The subject has been treated with an immunomodulatory drug, excluding topical treatment (e.g. ointments, nasal sprays) within 30 days before enrollment
Item
The subject has been treated with an immunomodulatory drug, excluding topical treatment (e.g. ointments, nasal sprays) within 30 days before enrollment
boolean
CL415147 (UMLS CUI 2011AA)
C0005525 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C0028912 (UMLS CUI 2011AA)
417519007 (SNOMED CT 2011_0131)
OINT (HL7 V3 2006_05)
C0461725 (UMLS CUI 2011AA)
385157007 (SNOMED CT 2011_0131)
NASSPRY (HL7 V3 2006_05)
The subject has been treated with drugs known to induce thrombotic thrombocytopenic purpura (TTP) (e.g. Adenosine diphosphate (ADP) receptor inhibitors (Clopidogrel, Ticlopidine)) within 60 days before enrollment
Item
The subject has been treated with drugs known to induce thrombotic thrombocytopenic purpura (TTP) (e.g. Adenosine diphosphate (ADP) receptor inhibitors (Clopidogrel, Ticlopidine)) within 60 days before enrollment
boolean
CL415147 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0034155 (UMLS CUI 2011AA)
78129009 (SNOMED CT 2011_0131)
10043648 (MedDRA 14.1)
M31.1 (ICD-10-CM Version 2010)
E10061 (CTCAE 1105E)
C1373149 (UMLS CUI 2011AA)
C0070166 (UMLS CUI 2011AA)
386952008 (SNOMED CT 2011_0131)
C0040207 (UMLS CUI 2011AA)
108971003 (SNOMED CT 2011_0131)
MTHU001495 (LOINC Version 232)
The subject is receiving or anticipates receiving another investigational and/or interventional drug within 30 days before enrollment
Item
The subject is receiving or anticipates receiving another investigational and/or interventional drug within 30 days before enrollment
boolean
C1514756 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
C0013227 (UMLS CUI 2011AA)
The subject is a lactating female
Item
The subject is a lactating female
boolean
C2828358 (UMLS CUI 2011AA)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
The subject has a history of drug or alcohol abuse within the last 5 years
Item
The subject has a history of drug or alcohol abuse within the last 5 years
boolean
C1299544 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
C0221628 (UMLS CUI 2011AA)
371434005 (SNOMED CT 2011_0131)
The subject has a progressive fatal disease and/or life expectancy of < 3 months
Item
The subject has a progressive fatal disease and/or life expectancy of < 3 months
boolean
C1302234 (UMLS CUI 2011AA)
399166001 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
Item
The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
C0680734 (UMLS CUI 2011AA)
The subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
Item
The subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
boolean
C0809986 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0424350 (UMLS CUI 2011AA)
248042003 (SNOMED CT 2011_0131)
Subject is in prison or compulsory detention by regulatory and/or juridical order
Item
Subject is in prison or compulsory detention by regulatory and/or juridical order
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0392751 (UMLS CUI 2011AA)
91497007 (SNOMED CT 2011_0131)