Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 12 Years to 70 Years
Item
Alter 12 bis 70 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males
Item
männlich
boolean
C0024554 (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
Ausschlusskriterien
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
Nierendysfunktion, Nierenfunktionsstörung
boolean
C1848822 (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)

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