Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
male and female patients age >= 18 and < 55
Item
Age >= 18 and < 55
boolean
C0001779 (UMLS CUI 2011AA)
weight between 50 and 100 kg
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
confirmed diagnosis of AE (UK working party criteria)
Item
confirmed diagnosis of AE (UK working party criteria)
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C0041700 (UMLS CUI 2011AA)
223860005 (SNOMED CT 2011_0131)
C0043227 (UMLS CUI 2011AA)
261041009 (SNOMED CT 2011_0131)
C1518904 (UMLS CUI 2011AA)
C0679228 (UMLS CUI 2011AA)
objective SCORAD > 40
Item
objective SCORAD > 40
boolean
C1571702 (UMLS CUI 2011AA)
260224007 (SNOMED CT 2011_0131)
MTHU036448 (LOINC Version 232)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
DLQI > 10
Item
DLQI > 10
boolean
C0205489 (UMLS CUI 2011AA)
64947008 (SNOMED CT 2011_0131)
C0518214 (UMLS CUI 2011AA)
405152002 (SNOMED CT 2011_0131)
C0918012 (UMLS CUI 2011AA)
resistancy against topical treatment options including steroids and calcineurin-inhibitors
Item
resistancy against topical treatment options including steroids and calcineurin-inhibitors
boolean
C0332325 (UMLS CUI 2011AA)
30714006 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0683525 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C1562036 (UMLS CUI 2011AA)
416798007 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
participation to another clinical trial within the last 4 weeks before baseline
Item
participation to another clinical trial within the last 4 weeks before baseline
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
pregnant or breastfeeding
Item
pregnant or breastfeeding
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
women of childbearing potential without adequate contraception
Item
women of childbearing potential without adequate contraception
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
allergy against prednisolone or Ciclosporine A
Item
allergy against prednisolone or Ciclosporine A
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
acute bacterial or viral infection
Item
acute bacterial or viral infection
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
malignant tumor in personal history
Item
History of neoplastic disease
boolean
C0006826 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
diabetes mellitus
Item
Diabetes mellitus
boolean
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
arterial hypertension
Item
Hypertensive disease, High Blood Pressure
boolean
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
Glaucoma
Item
Glaucoma
boolean
C0017601 (UMLS CUI 2011AA)
23986001 (SNOMED CT 2011_0131)
10018304 (MedDRA 14.1)
MTHU020819 (LOINC Version 232)
H40-H42 (ICD-10-CM Version 2010)
365 (ICD-9-CM Version 2011)
E10392 (CTCAE 1105E)
peptic ulcer
Item
Peptic Ulcer
boolean
C0030920 (UMLS CUI 2011AA)
13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
severe osteoporosis
Item
Severe osteoporosis
boolean
C1859443 (UMLS CUI 2011AA)
tuberculosis in personal history
Item
Personal history of tuberculosis
boolean
C0375796 (UMLS CUI 2011AA)
Z86.11 (ICD-10-CM Version 2010)
V12.01 (ICD-9-CM Version 2011)
colitis ulcerosa
Item
Ulcerative colitis (UC), Colitis ulcerative
boolean
C0302596 (UMLS CUI 2011AA)
64766004 (SNOMED CT 2011_0131)
10009900 (MedDRA 14.1)
K51 (ICD-10-CM Version 2010)
556 (ICD-9-CM Version 2011)
diverticulitis
Item
Diverticulitis
boolean
C0012813 (UMLS CUI 2011AA)
307496006 (SNOMED CT 2011_0131)
10013538 (MedDRA 14.1)
concurrent treatment with chloroquin, Mefloquin, Statins, Warafin
Item
concurrent treatment with chloroquin, Mefloquin, Statins, Warafin
boolean
C0009429 (UMLS CUI 2011AA)
C0008269 (UMLS CUI 2011AA)
373468005 (SNOMED CT 2011_0131)
MTHU014870 (LOINC Version 232)
C0025153 (UMLS CUI 2011AA)
387505001 (SNOMED CT 2011_0131)
MTHU013611 (LOINC Version 232)
C0360714 (UMLS CUI 2011AA)
372912004 (SNOMED CT 2011_0131)
C0043031 (UMLS CUI 2011AA)
48603004 (SNOMED CT 2011_0131)
MTHU003212 (LOINC Version 232)
Creatinin Clearance < 60 ml /min
Item
Creatinine clearance (CrCl) measurement
boolean
C0201976 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
UV treatment within 8 weeks before inclusion
Item
UV treatment within 8 weeks before inclusion
boolean
C0041626 (UMLS CUI 2011AA)
363695005 (SNOMED CT 2011_0131)
10046850 (MedDRA 14.1)
99.82 (ICD-9-CM Version 2011)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
ongoing systemic immunosuppressive treatment
Item
ongoing systemic immunosuppressive treatment
boolean
C0750536 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
planned vaccination within 8 weeks before study entry, during study and 2 weeks after end of study
Item
planned vaccination within 8 weeks before study entry, during study and 2 weeks after end of study
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0042196 (UMLS CUI 2011AA)
33879002 (SNOMED CT 2011_0131)
10046859 (MedDRA 14.1)
MTHU000146 (LOINC Version 232)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL421124 (UMLS CUI 2011AA)
Poliomyelitis
Item
POLIOMYELITIS
boolean
CL415131 (UMLS CUI 2011AA)
Lymphadenitis after BCG vaccination
Item
Lymphadenitis after BCG vaccination
boolean
C0024205 (UMLS CUI 2011AA)
19471005 (SNOMED CT 2011_0131)
10025188 (MedDRA 14.1)
I88.1 (ICD-10-CM Version 2010)
E11449 (CTCAE 1105E)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0199804 (UMLS CUI 2011AA)
42284007 (SNOMED CT 2011_0131)
99.33 (ICD-9-CM Version 2011)
Hyperuricaemia
Item
Hyperuricemia
boolean
C0740394 (UMLS CUI 2011AA)
35885006 (SNOMED CT 2011_0131)
10020903 (MedDRA 14.1)
E12305 (CTCAE 1105E)
chronic liver disease
Item
Chronic liver disease
boolean
C0341439 (UMLS CUI 2011AA)
328383001 (SNOMED CT 2011_0131)
10008953 (MedDRA 14.1)
Xeroderma pigmentosum, Cockaye-Syndrome, Bloom Syndrome
Item
Xeroderma pigmentosum, Cockaye-Syndrome, Bloom Syndrome
boolean
C0043346 (UMLS CUI 2011AA)
44600005 (SNOMED CT 2011_0131)
10048220 (MedDRA 14.1)
Q82.1 (ICD-10-CM Version 2010)
C0009207 (UMLS CUI 2011AA)
21086008 (SNOMED CT 2011_0131)
10009835 (MedDRA 14.1)
Q87.1 (ICD-10-CM Version 2010)
C0005859 (UMLS CUI 2011AA)
4434006 (SNOMED CT 2011_0131)
Psychiatric co-morbidity
Item
Psychiatric co-morbidity
boolean
C0205487 (UMLS CUI 2011AA)
27296002 (SNOMED CT 2011_0131)
MTHU002618 (LOINC Version 232)
C0009488 (UMLS CUI 2011AA)
drug or alcohol abuse
Item
drug or alcohol abuse
boolean
C0237123 (UMLS CUI 2011AA)

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