ID

43390

Description

ODM derived from http://clinicaltrials.gov/show/NCT00623727

Link

http://clinicaltrials.gov/show/NCT00623727

Keywords

Versions (3)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00623727 Hemophilia A

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 12 Years to 70 Years
Description

age 12 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
male, male gender
Description

Males

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
Description

Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)

Data type

boolean

Alias
UMLS CUI 2011AA
C0272322
SNOMED CT 2011_0131
16872008
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
Subjects with >= 150 exposure days (EDs) with any FVIII in total
Description

Subjects with >= 150 exposure days (EDs) with any FVIII in total

Data type

boolean

Alias
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
C0439810
SNOMED CT 2011_0131
255619001
Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
Description

Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule

Data type

boolean

Alias
UMLS CUI 2011AA
C0679686
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C2347946
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
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C0199176
SNOMED CT 2011_0131
360271000
MedDRA 14.1
10036898
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0086960
Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
Description

Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records

Data type

boolean

Alias
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
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0025102
SNOMED CT 2011_0131
129465004
LOINC Version 232
MTHU002728
Subjects with no measurable inhibitor activity
Description

Subjects with no measurable inhibitor activity

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0368953
SNOMED CT 2011_0131
58730008
LOINC Version 232
MTHU014157
UMLS CUI 2011AA
C0441655
SNOMED CT 2011_0131
257733005
LOINC Version 232
MTHU002837
ICD-9-CM Version 2011
E001-E030.9
Subjects with no history of FVIII inhibitor antibody formation
Description

Subjects with no history of FVIII inhibitor antibody formation

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0368953
SNOMED CT 2011_0131
58730008
LOINC Version 232
MTHU014157
UMLS CUI 2011AA
C0003241
SNOMED CT 2011_0131
68498002
LOINC Version 232
MTHU003502
UMLS CUI 2011AA
C1522492
Written informed consent by subject and parent / legal representative, if < 18 years
Description

Written informed consent by subject and parent / legal representative, if < 18 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Subjects who are receiving primary prophylaxis
Description

Subjects who are receiving primary prophylaxis

Data type

boolean

Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
Description

Subjects on prophylaxis with documented requirements of > 75 IU/kg/week

Data type

boolean

Alias
UMLS CUI 2011AA
C0199176
SNOMED CT 2011_0131
360271000
MedDRA 14.1
10036898
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0439453
SNOMED CT 2011_0131
258997004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
Description

Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
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
UMLS CUI 2011AA
C0042974
SNOMED CT 2011_0131
128105004
MedDRA 14.1
10047715
ICD-10-CM Version 2010
D68.0
ICD-9-CM Version 2011
286.4
Renal dysfunction
Description

Subjects with abnormal renal function

Data type

boolean

Alias
UMLS CUI 2011AA
C0151746
Elevated hepatic transaminases
Description

Subjects with elevated hepatic transaminases

Data type

boolean

Alias
UMLS CUI 2011AA
C1848701
Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
Description

Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0005525
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
Description

Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0439861
SNOMED CT 2011_0131
105590001
UMLS CUI 2011AA
C1334805
UMLS CUI 2011AA
C0018557
SNOMED CT 2011_0131
392390005
UMLS CUI 2011AA
C0033684
SNOMED CT 2011_0131
88878007
LOINC Version 232
MTHU001951
UMLS CUI 2011AA
C0023828
UMLS CUI 2011AA
C0032483
SNOMED CT 2011_0131
8030004
Subjects who require any pre-medication for FVIII injections
Description

Subjects who require any pre-medication for FVIII injections

Data type

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0033045
MedDRA 14.1
10036500
UMLS CUI 2011AA
C0015506
SNOMED CT 2011_0131
278910002, 259736008
LOINC Version 232
MTHU009422
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 12 Years to 70 Years
Item
age 12 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males
Item
male, male gender
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
Item
Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
boolean
C0272322 (UMLS CUI 2011AA)
16872008 (SNOMED CT 2011_0131)
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)
Subjects with >= 150 exposure days (EDs) with any FVIII in total
Item
Subjects with >= 150 exposure days (EDs) with any FVIII in total
boolean
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)
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
Item
Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
boolean
C0679686 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C2347946 (UMLS CUI 2011AA)
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)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0199176 (UMLS CUI 2011AA)
360271000 (SNOMED CT 2011_0131)
10036898 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
Item
Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
boolean
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)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0025102 (UMLS CUI 2011AA)
129465004 (SNOMED CT 2011_0131)
MTHU002728 (LOINC Version 232)
Subjects with no measurable inhibitor activity
Item
Subjects with no measurable inhibitor activity
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1513040 (UMLS CUI 2011AA)
C0368953 (UMLS CUI 2011AA)
58730008 (SNOMED CT 2011_0131)
MTHU014157 (LOINC Version 232)
C0441655 (UMLS CUI 2011AA)
257733005 (SNOMED CT 2011_0131)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
Subjects with no history of FVIII inhibitor antibody formation
Item
Subjects with no history of FVIII inhibitor antibody formation
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0368953 (UMLS CUI 2011AA)
58730008 (SNOMED CT 2011_0131)
MTHU014157 (LOINC Version 232)
C0003241 (UMLS CUI 2011AA)
68498002 (SNOMED CT 2011_0131)
MTHU003502 (LOINC Version 232)
C1522492 (UMLS CUI 2011AA)
Written informed consent by subject and parent / legal representative, if < 18 years
Item
Written informed consent by subject and parent / legal representative, if < 18 years
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Subjects who are receiving primary prophylaxis
Item
Subjects who are receiving primary prophylaxis
boolean
Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
Item
Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
boolean
C0199176 (UMLS CUI 2011AA)
360271000 (SNOMED CT 2011_0131)
10036898 (MedDRA 14.1)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0439453 (UMLS CUI 2011AA)
258997004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
Item
Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
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)
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)
Subjects with abnormal renal function
Item
Renal dysfunction
boolean
C0151746 (UMLS CUI 2011AA)
Subjects with elevated hepatic transaminases
Item
Elevated hepatic transaminases
boolean
C1848701 (UMLS CUI 2011AA)
Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
Item
Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
boolean
C0039798 (UMLS CUI 2011AA)
C0005525 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
Item
Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0439861 (UMLS CUI 2011AA)
105590001 (SNOMED CT 2011_0131)
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)
C0023828 (UMLS CUI 2011AA)
C0032483 (UMLS CUI 2011AA)
8030004 (SNOMED CT 2011_0131)
Subjects who require any pre-medication for FVIII injections
Item
Subjects who require any pre-medication for FVIII injections
boolean
C1514873 (UMLS CUI 2011AA)
C0033045 (UMLS CUI 2011AA)
10036500 (MedDRA 14.1)
C0015506 (UMLS CUI 2011AA)
278910002, 259736008 (SNOMED CT 2011_0131)
MTHU009422 (LOINC Version 232)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial