ID

3675

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01233440

Link

http://clinicaltrials.gov/show/NCT01233440

Stichworte

Versionen (3)
  1. 12.02.13 12.02.13 - Martin Dugas
  2. 19.04.14 19.04.14 - Julian Varghese
  3. 27.09.21 27.09.21 -
Hochgeladen am

12. Februar 2013

DOI

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Lizenz

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Eligibility NCT01233440 Hemophilia B

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

age 12 Years to 65 Years
Beschreibung

age 12 Years to 65 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male, 12 - 65 years, with body weight >= 30 kg and <= 120 kg
Beschreibung

Male, 12 - 65 years, with body weight >= 30 kg and <= 120 kg

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
Documented severe Hemophilia B (FIX activity of <= 2%) or tested by the central laboratory at screening
Beschreibung

Documented severe Hemophilia B (FIX activity of <= 2%) or tested by the central laboratory at screening

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0008533
SNOMED CT 2011_0131
41788008
MedDRA 14.1
10016077
ICD-10-CM Version 2010
D67
ICD-9-CM Version 2011
286.1
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0368934
LOINC Version 232
MTHU014834
UMLS CUI 2011AA
C0871311
MedDRA 14.1
10072089
Subjects who have received FIX products for > 150 exposure days (EDs) (estimated)
Beschreibung

Subjects who have received FIX products for > 150 exposure days (EDs) (estimated)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1827657
SNOMED CT 2011_0131
424562004
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0302077
SNOMED CT 2011_0131
36020009
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1707491
UMLS CUI 2011AA
C1335447
UMLS CUI 2011AA
C0302077
SNOMED CT 2011_0131
36020009
UMLS CUI 2011AA
CL415098
UMLS CUI 2011AA
C0439151
SNOMED CT 2011_0131
258725007
HL7 V3 2006_05
[BETH'U]
UMLS CUI 2011AA
C1409616
Subjects can be treated on-demand or under prophylactic therapy
Beschreibung

Subjects can be treated on-demand or under prophylactic therapy

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0679686
UMLS CUI 2011AA
C0445202
SNOMED CT 2011_0131
262073000
MedDRA 14.1
10036893
UMLS CUI 2011AA
C0039798
Signed Informed Consent/Assent
Beschreibung

Signed Informed Consent/Assent

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein
Beschreibung

Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0002792
SNOMED CT 2011_0131
39579001
MedDRA 14.1
10002199
ICD-10-CM Version 2010
T78.2
CTCAE 1105E
E11254
UMLS CUI 2011AA
C1827657
SNOMED CT 2011_0131
424562004
UMLS CUI 2011AA
C0018557
SNOMED CT 2011_0131
392390005
UMLS CUI 2011AA
C0033684
SNOMED CT 2011_0131
88878007
LOINC Version 232
MTHU001951
Any known congenital or acquired coagulation disorder other than congenital FIX deficiency
Beschreibung

Any known congenital or acquired coagulation disorder other than congenital FIX deficiency

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
UMLS CUI 2011AA
C0398622
SNOMED CT 2011_0131
234466008
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0008533
SNOMED CT 2011_0131
41788008
MedDRA 14.1
10016077
ICD-10-CM Version 2010
D67
ICD-9-CM Version 2011
286.1
Platelet count - finding
Beschreibung

Platelet count < 100,000/microL

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
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)
Beschreibung

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)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0085393
SNOMED CT 2011_0131
370388006
UMLS CUI 2011AA
C1277776
SNOMED CT 2011_0131
313660005
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0033607
SNOMED CT 2011_0131
412127001
UMLS CUI 2011AA
C2363964
MedDRA 14.1
10068724
Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment
Beschreibung

Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0005525
UMLS CUI 2011AA
C0021027
SNOMED CT 2011_0131
399771004
HL7 V3 2006_05
14
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C1515119
Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration > 5 times (x) the upper limit of normal (ULN)
Beschreibung

Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration > 5 times (x) the upper limit of normal (ULN)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
Serum creatinine > 2 x ULN
Beschreibung

Serum creatinine > 2 x ULN

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1519815
Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment
Beschreibung

Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0040053
SNOMED CT 2011_0131
439127006
MedDRA 14.1
10043607
UMLS CUI 2011AA
C0149871
SNOMED CT 2011_0131
128053003
MedDRA 14.1
10051055
ICD-10-CM Version 2010
I82.40
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
C0034065
SNOMED CT 2011_0131
59282003
MedDRA 14.1
10037377
ICD-10-CM Version 2010
I26
ICD-9-CM Version 2011
415.1
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0549124
SNOMED CT 2011_0131
54687002
MedDRA 14.1
10014513
Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration
Beschreibung

Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1514798
UMLS CUI 2011AA
C0015491
SNOMED CT 2011_0131
54378000
UMLS CUI 2011AA
C0162768
SNOMED CT 2011_0131
422055000
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry
Beschreibung

Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C1970394
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0162439
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0015491
SNOMED CT 2011_0131
54378000
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance
Beschreibung

Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0023015
SNOMED CT 2011_0131
62305002
ICD-10-CM Version 2010
F80.9
UMLS CUI 2011AA
C0278060
SNOMED CT 2011_0131
36456004
LOINC Version 232
MTHU001424
CTCAE 1105E
MTHU117157
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C0496735
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
age 12 Years to 65 Years
Item
age 12 Years to 65 Years
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
C0024554 (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)
C1827657 (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
C1519316 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
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)
C1827657 (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
Platelet count - finding
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)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (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)
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