ID

3841

Description

ODM derived from http://clinicaltrials.gov/show/NCT01376700

Link

http://clinicaltrials.gov/show/NCT01376700

Keywords

  1. 4/17/13 4/17/13 - Martin Dugas
Uploaded on

April 17, 2013

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT01376700 Hemophilia A

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age up to 1 Year
Description

age up to 1 Year

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects with severe and moderately severe hemophilia A (FVIII <= 2%). Certain FVIII mutation types (e.g., large multi-domain deletions, nonsense mutations, insertions/deletions/inversions that result in a premature stop codon, intron 22 inversions) can be used to corroborate a severe hemophilia A phenotype when laboratory assays show FVIII levels >= 1% because of rounding errors or carryover effect from a previous FVIII administration. A central laboratory FVIII assay is required to confirm subject eligibility.
Description

Subjects with severe and moderately severe hemophilia A (FVIII <= 2%). Certain FVIII mutation types (e.g., large multi-domain deletions, nonsense mutations, insertions/deletions/inversions that result in a premature stop codon, intron 22 inversions) can be used to corroborate a severe hemophilia A phenotype when laboratory assays show FVIII levels >= 1% because of rounding errors or carryover effect from a previous FVIII administration. A central laboratory FVIII assay is required to confirm subject eligibility.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
UMLS CUI 2011AA
C0019069
SNOMED CT 2011_0131
234440005
MedDRA 14.1
10016080
ICD-10-CM Version 2010
D66
ICD-9-CM Version 2011
286.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0015506
SNOMED CT 2011_0131
278910002, 259736008
LOINC Version 232
MTHU009422
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C0544885
SNOMED CT 2011_0131
327671006
UMLS CUI 2011AA
C0205252
SNOMED CT 2011_0131
1090009
UMLS CUI 2011AA
C0242611
UMLS CUI 2011AA
C0272322
SNOMED CT 2011_0131
16872008
UMLS CUI 2011AA
C0031437
SNOMED CT 2011_0131
8116006
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1880016
UMLS CUI 2011AA
C0200399
SNOMED CT 2011_0131
269819008
Subjects must have <= 3 exposure days (EDs) to any FVIII concentrate or FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more than 2 infusions per event), or for preventative or precautionary infusions following possible injury
Description

Subjects must have <= 3 exposure days (EDs) to any FVIII concentrate or FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more than 2 infusions per event), or for preventative or precautionary infusions following possible injury

Data type

boolean

Alias
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
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
C0015506
SNOMED CT 2011_0131
278910002, 259736008
LOINC Version 232
MTHU009422
UMLS CUI 2011AA
C2003864
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C3160770
MedDRA 14.1
10070922
Subjects with prior circumcision are allowed to enroll only if bleeding issues related to circumcision were the cause for the original diagnosis of hemophilia A and no more than 2 EDs of FVIII treatment were required
Description

Subjects with prior circumcision are allowed to enroll only if bleeding issues related to circumcision were the cause for the original diagnosis of hemophilia A and no more than 2 EDs of FVIII treatment were required

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1704304
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
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
UMLS CUI 2011AA
C0033213
SNOMED CT 2011_0131
55607006
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0019069
SNOMED CT 2011_0131
234440005
MedDRA 14.1
10016080
ICD-10-CM Version 2010
D66
ICD-9-CM Version 2011
286.0
Adequate venous access (without need for CVAD-placement) as determined by the physician
Description

Adequate venous access (without need for CVAD-placement) as determined by the physician

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0348013
SNOMED CT 2011_0131
263925004
UMLS CUI 2011AA
C0444454
SNOMED CT 2011_0131
260507000
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C1145640
SNOMED CT 2011_0131
52124006
UMLS CUI 2011AA
C0441587
SNOMED CT 2011_0131
71861002, 257867005
HL7 V3 2006_05
_Insertion
Written informed consent from legally authorized representative(s)
Description

Written informed consent from legally authorized representative(s)

Data type

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C1301860
SNOMED CT 2011_0131
398165009
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Life-threatening conditions (intracranial hemorrhage, severe trauma) or requirement for surgery at the time of enrollment
Description

Life-threatening conditions (intracranial hemorrhage, severe trauma) or requirement for surgery at the time of enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0151699
SNOMED CT 2011_0131
1386000
MedDRA 14.1
10018985
ICD-9-CM Version 2011
432.9
CTCAE 1105E
E12696
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0038895
Evidence of inhibitor >= 0.6 BU in Nijmegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitor test results)
Description

Evidence of inhibitor >= 0.6 BU in Nijmegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitor test results)

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0368953
SNOMED CT 2011_0131
58730008
LOINC Version 232
MTHU014157
UMLS CUI 2011AA
C0439151
SNOMED CT 2011_0131
258725007
HL7 V3 2006_05
[BETH'U]
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1510438
SNOMED CT 2011_0131
272392009
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C2346630
Inherited or acquired hemostatic defect other than hemophilia A
Description

Inherited or acquired hemostatic defect other than hemophilia A

Data type

boolean

Alias
UMLS CUI 2011AA
CL035566
UMLS CUI 2011AA
C0439661
SNOMED CT 2011_0131
255396000
UMLS CUI 2011AA
C0019116
SNOMED CT 2011_0131
74848003
UMLS CUI 2011AA
C1457869
SNOMED CT 2011_0131
6920004
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0019069
SNOMED CT 2011_0131
234440005
MedDRA 14.1
10016080
ICD-10-CM Version 2010
D66
ICD-9-CM Version 2011
286.0
Any clinically significant, chronic disease other than hemophilia A
Description

Any clinically significant, chronic disease other than hemophilia A

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0008679
SNOMED CT 2011_0131
27624003
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0019069
SNOMED CT 2011_0131
234440005
MedDRA 14.1
10016080
ICD-10-CM Version 2010
D66
ICD-9-CM Version 2011
286.0
Known hypersensitivity to ADVATE or any of its constituents
Description

Known hypersensitivity to ADVATE or any of its constituents

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1815260
UMLS CUI 2011AA
C0729650
SNOMED CT 2011_0131
312297002
Any planned elective surgery that cannot be postponed until after the first 20 EDs
Description

Any planned elective surgery that cannot be postponed until after the first 20 EDs

Data type

boolean

Alias
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0206058
SNOMED CT 2011_0131
274075007
MedDRA 14.1
10058829
UMLS CUI 2011AA
C0205421
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age up to 1 Year
Item
age up to 1 Year
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects with severe and moderately severe hemophilia A (FVIII <= 2%). Certain FVIII mutation types (e.g., large multi-domain deletions, nonsense mutations, insertions/deletions/inversions that result in a premature stop codon, intron 22 inversions) can be used to corroborate a severe hemophilia A phenotype when laboratory assays show FVIII levels >= 1% because of rounding errors or carryover effect from a previous FVIII administration. A central laboratory FVIII assay is required to confirm subject eligibility.
Item
Subjects with severe and moderately severe hemophilia A (FVIII <= 2%). Certain FVIII mutation types (e.g., large multi-domain deletions, nonsense mutations, insertions/deletions/inversions that result in a premature stop codon, intron 22 inversions) can be used to corroborate a severe hemophilia A phenotype when laboratory assays show FVIII levels >= 1% because of rounding errors or carryover effect from a previous FVIII administration. A central laboratory FVIII assay is required to confirm subject eligibility.
boolean
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0019069 (UMLS CUI 2011AA)
234440005 (SNOMED CT 2011_0131)
10016080 (MedDRA 14.1)
D66 (ICD-10-CM Version 2010)
286.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0015506 (UMLS CUI 2011AA)
278910002, 259736008 (SNOMED CT 2011_0131)
MTHU009422 (LOINC Version 232)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0544885 (UMLS CUI 2011AA)
327671006 (SNOMED CT 2011_0131)
C0205252 (UMLS CUI 2011AA)
1090009 (SNOMED CT 2011_0131)
C0242611 (UMLS CUI 2011AA)
C0272322 (UMLS CUI 2011AA)
16872008 (SNOMED CT 2011_0131)
C0031437 (UMLS CUI 2011AA)
8116006 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C1880016 (UMLS CUI 2011AA)
C0200399 (UMLS CUI 2011AA)
269819008 (SNOMED CT 2011_0131)
Subjects must have <= 3 exposure days (EDs) to any FVIII concentrate or FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more than 2 infusions per event), or for preventative or precautionary infusions following possible injury
Item
Subjects must have <= 3 exposure days (EDs) to any FVIII concentrate or FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more than 2 infusions per event), or for preventative or precautionary infusions following possible injury
boolean
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (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)
C0015506 (UMLS CUI 2011AA)
278910002, 259736008 (SNOMED CT 2011_0131)
MTHU009422 (LOINC Version 232)
C2003864 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C3160770 (UMLS CUI 2011AA)
10070922 (MedDRA 14.1)
Subjects with prior circumcision are allowed to enroll only if bleeding issues related to circumcision were the cause for the original diagnosis of hemophilia A and no more than 2 EDs of FVIII treatment were required
Item
Subjects with prior circumcision are allowed to enroll only if bleeding issues related to circumcision were the cause for the original diagnosis of hemophilia A and no more than 2 EDs of FVIII treatment were required
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1704304 (UMLS CUI 2011AA)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (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)
C0033213 (UMLS CUI 2011AA)
55607006 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0019069 (UMLS CUI 2011AA)
234440005 (SNOMED CT 2011_0131)
10016080 (MedDRA 14.1)
D66 (ICD-10-CM Version 2010)
286.0 (ICD-9-CM Version 2011)
Adequate venous access (without need for CVAD-placement) as determined by the physician
Item
Adequate venous access (without need for CVAD-placement) as determined by the physician
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0348013 (UMLS CUI 2011AA)
263925004 (SNOMED CT 2011_0131)
C0444454 (UMLS CUI 2011AA)
260507000 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C1145640 (UMLS CUI 2011AA)
52124006 (SNOMED CT 2011_0131)
C0441587 (UMLS CUI 2011AA)
71861002, 257867005 (SNOMED CT 2011_0131)
_Insertion (HL7 V3 2006_05)
Written informed consent from legally authorized representative(s)
Item
Written informed consent from legally authorized representative(s)
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C1301860 (UMLS CUI 2011AA)
398165009 (SNOMED CT 2011_0131)
C1524004 (UMLS CUI 2011AA)
C0030701 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Life-threatening conditions (intracranial hemorrhage, severe trauma) or requirement for surgery at the time of enrollment
Item
Life-threatening conditions (intracranial hemorrhage, severe trauma) or requirement for surgery at the time of enrollment
boolean
C2826244 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0151699 (UMLS CUI 2011AA)
1386000 (SNOMED CT 2011_0131)
10018985 (MedDRA 14.1)
432.9 (ICD-9-CM Version 2011)
E12696 (CTCAE 1105E)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
Evidence of inhibitor >= 0.6 BU in Nijmegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitor test results)
Item
Evidence of inhibitor >= 0.6 BU in Nijmegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitor test results)
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0368953 (UMLS CUI 2011AA)
58730008 (SNOMED CT 2011_0131)
MTHU014157 (LOINC Version 232)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1510438 (UMLS CUI 2011AA)
272392009 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C2346630 (UMLS CUI 2011AA)
Inherited or acquired hemostatic defect other than hemophilia A
Item
Inherited or acquired hemostatic defect other than hemophilia A
boolean
CL035566 (UMLS CUI 2011AA)
C0439661 (UMLS CUI 2011AA)
255396000 (SNOMED CT 2011_0131)
C0019116 (UMLS CUI 2011AA)
74848003 (SNOMED CT 2011_0131)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0019069 (UMLS CUI 2011AA)
234440005 (SNOMED CT 2011_0131)
10016080 (MedDRA 14.1)
D66 (ICD-10-CM Version 2010)
286.0 (ICD-9-CM Version 2011)
Any clinically significant, chronic disease other than hemophilia A
Item
Any clinically significant, chronic disease other than hemophilia A
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0008679 (UMLS CUI 2011AA)
27624003 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0019069 (UMLS CUI 2011AA)
234440005 (SNOMED CT 2011_0131)
10016080 (MedDRA 14.1)
D66 (ICD-10-CM Version 2010)
286.0 (ICD-9-CM Version 2011)
Known hypersensitivity to ADVATE or any of its constituents
Item
Known hypersensitivity to ADVATE or any of its constituents
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1815260 (UMLS CUI 2011AA)
C0729650 (UMLS CUI 2011AA)
312297002 (SNOMED CT 2011_0131)
Any planned elective surgery that cannot be postponed until after the first 20 EDs
Item
Any planned elective surgery that cannot be postponed until after the first 20 EDs
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0206058 (UMLS CUI 2011AA)
274075007 (SNOMED CT 2011_0131)
10058829 (MedDRA 14.1)
C0205421 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)

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