Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
Age
Item
16 Jahre und älter
boolean
consent
Item
Written informed consent
boolean
Chronic Plaque Psoriasis
Item
Diagnosed with chronic plaque psoriasis and require systemic therapy
boolean
CD4+
Item
CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
boolean
Item Group
Ausschlusskriterien
Unstable erthrodermic or pustular psoriasis
Item
Unstable erthrodermic or pustular psoriasis
boolean
guttate psoriasis
Item
Diagnosis of guttate psoriasis
boolean
Serious infection
Item
Serious local infection or systemic infection within 3 months prior to first dose of alefacept
boolean
HIV
Item
Positive for HIV antibody
boolean
Cancer
Item
Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded
boolean
tuberculosis
Item
Evidence of active tuberculosis, Current treatment for active tuberculosis or tuberculosis prophylaxis
boolean
contraception
Item
Female patients unwilling to practice effective contraception as defined by the investigator
boolean
pregnant or breast-feeding
Item
Female patients who are pregnant or breast-feeding
boolean
other study
Item
Current enrollment in any other investigational drug study
boolean
Previous alefacept
Item
Previous participation in this study or previous alefacept studies
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2011_0131)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Psoriasis
Item
Psoriasis
string
C0033860 (UMLS CUI)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.0)
L40 (ICD-10-CM Version 2010)
Systemic Therapy
Item
Systemische Therapie
string
C1515119 (UMLS CUI)
CD4+ lymphocyte count
Item
CD4+ Anzahl
string
C1277776 (UMLS CUI)
313660005 (SNOMED CT 2011_0131)
erythrodermic psoriasis
Item
exfoliative psoriasis
string
C0748052 (UMLS CUI)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.0)
guttate psoriasis
Item
Psoriasis guttata
string
C0343052 (UMLS CUI)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
pustular psoriasis
Item
pustular psoriasis
string
C0152081 (UMLS CUI)
200973000 (SNOMED CT 2011_0131)
10037159 (MedDRA 14.0)
Infection
Item
Infektion
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.0)
HIV Infection
Item
HIV Infektion
string
C0019693 (UMLS CUI)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.0)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.0)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Pharmaceutical Preparations
Item
Medikation
string
C0013227 (UMLS CUI)
Tuberculosis
Item
Tuberkulose
string
C0041296 (UMLS CUI)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.0)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.0)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 14.0)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 14.0)
Enrollment
Item
Registrierung
string
C2348568 (UMLS CUI)
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