ID

5010

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00820365

Link

http://clinicaltrials.gov/show/NCT00820365

Stichworte

Versionen (3)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 16.04.14 16.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

16. April 2014

DOI

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Lizenz

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Eligibility NCT00820365 Inflammatory Bowel Disease (IBD)

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 70 Jahre
Beschreibung

Age 18 Years to 70 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Established diagnosis of CD, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
Beschreibung

Established diagnosis of CD, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
UMLS CUI 2011AA
C0041618
SNOMED CT 2011_0131
16310003
MedDRA 14.1
10065594
LOINC Version 232
MTHU000076
HL7 V3 2006_05
12
UMLS CUI 2011AA
C0043299
SNOMED CT 2011_0131
363680008
ICD-9-CM Version 2011
87
Patients must be in clinical remission (Crohn's Disease Activity Index [CDAI] <150 points) on steroid therapy for at least 2 weeks
Beschreibung

Patients must be in clinical remission (Crohn's Disease Activity Index [CDAI] <150 points) on steroid therapy for at least 2 weeks

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
UMLS CUI 2011AA
C0451071
SNOMED CT 2011_0131
273364009
UMLS CUI 2011AA
C0149783
SNOMED CT 2011_0131
297279009
MedDRA 14.1
10062117
Confirmed steroid-dependency of CD: patients who are either
Beschreibung

Confirmed steroid-dependency of CD: patients who are either

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
CL414916
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
Beschreibung

unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0038317
who have a relapse within 2 months of stopping steroids
Beschreibung

who have a relapse within 2 months of stopping steroids

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1947925
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose
Beschreibung

Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0449864
SNOMED CT 2011_0131
118589004
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
CL415123
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week
Beschreibung

Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0017710
SNOMED CT 2011_0131
419933005
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
CL415123
Established diagnosis of UC, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
Beschreibung

Established diagnosis of UC, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0302596
SNOMED CT 2011_0131
64766004
MedDRA 14.1
10009900
ICD-10-CM Version 2010
K51
ICD-9-CM Version 2011
556
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
UMLS CUI 2011AA
C0041618
SNOMED CT 2011_0131
16310003
MedDRA 14.1
10065594
LOINC Version 232
MTHU000076
HL7 V3 2006_05
12
UMLS CUI 2011AA
C0043299
SNOMED CT 2011_0131
363680008
ICD-9-CM Version 2011
87
Patients must be in clinical remission (Clinical Activity Index [CAI] <4 points) on steroid therapy for at least 2 weeks
Beschreibung

Patients must be in clinical remission (Clinical Activity Index [CAI] <4 points) on steroid therapy for at least 2 weeks

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
UMLS CUI 2011AA
C0451071
SNOMED CT 2011_0131
273364009
UMLS CUI 2011AA
C0149783
SNOMED CT 2011_0131
297279009
MedDRA 14.1
10062117
Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose
Beschreibung

Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0449864
SNOMED CT 2011_0131
118589004
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
CL415123
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week (* The threshold dose is that dose at which the patient experienced the relapses)
Beschreibung

Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week (* The threshold dose is that dose at which the patient experienced the relapses)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0017710
SNOMED CT 2011_0131
419933005
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
CL415123
Written informed consent
Beschreibung

Written informed consent

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Negative pregnancy test at screening in females of child-bearing potential
Beschreibung

Negative pregnancy test at screening in females of child-bearing potential

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
Males willing to use condoms or to be sexually abstinent
Beschreibung

Males willing to use condoms or to be sexually abstinent

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
Use of appropriate contraceptive methods for females of childbearing potential one month before, throughout the course of the study and one month after study termination. This must be a combination of the following:
Beschreibung

Use of appropriate contraceptive methods for females of childbearing potential one month before, throughout the course of the study and one month after study termination. This must be a combination of the following:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
a highly effective method of first choice = a method with a low failure rate (i.e. < 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some Intra Uterine Devices (IUDs), vasectomized partner together with
Beschreibung

a highly effective method of first choice = a method with a low failure rate (i.e. < 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some Intra Uterine Devices (IUDs), vasectomized partner together with

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
a method of second choice like condom, diaphragm, or cup pessary
Beschreibung

a method of second choice like condom, diaphragm, or cup pessary

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0031246
SNOMED CT 2011_0131
46625003
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Syndrom des kurzen Darms
Beschreibung

Short bowel syndrome

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0036992
SNOMED CT 2011_0131
26629001
MedDRA 14.1
10049416
Ileostomy, colostomy or rectal pouch
Beschreibung

Ileostomy, colostomy or rectal pouch

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0020883
SNOMED CT 2011_0131
173977007
MedDRA 14.1
10021321
ICD-9-CM Version 2011
46.20
UMLS CUI 2011AA
C0009410
SNOMED CT 2011_0131
398740003
MedDRA 14.1
10010041
ICD-9-CM Version 2011
46.10
UMLS CUI 2011AA
C0939964
Relapse during screening
Beschreibung

Relapse during screening

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C1409616
History of or existence of active tuberculosis
Beschreibung

History of or existence of active tuberculosis

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0375796
ICD-10-CM Version 2010
Z86.11
ICD-9-CM Version 2011
V12.01
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0151332
SNOMED CT 2011_0131
427099000
MedDRA 14.1
10071157
History of or existence of urolithiasis
Beschreibung

History of or existence of urolithiasis

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0451641
SNOMED CT 2011_0131
95566004
MedDRA 14.1
10046707
ICD-10-CM Version 2010
N20-N23
History of or existence of human immune deficiency virus (HIV), Hepatitis B or C
Beschreibung

History of or existence of human immune deficiency virus (HIV), Hepatitis B or C

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
UMLS CUI 2011AA
C1997078
SNOMED CT 2011_0131
429721005
History of malignancy within the past five years (excluding basal cell carcinoma of the skin)
Beschreibung

History of malignancy within the past five years (excluding basal cell carcinoma of the skin)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
Previous opportunistic infection
Beschreibung

Previous opportunistic infection

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0029118
SNOMED CT 2011_0131
61274003
MedDRA 14.1
10030901
History of serious drug sensitivity
Beschreibung

History of serious drug sensitivity

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0237865
SNOMED CT 2011_0131
419511003
Significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ECG)
Beschreibung

Significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ECG)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0428977
SNOMED CT 2011_0131
48867003
MedDRA 14.1
10006093
ICD-10-CM Version 2010
R00.1
UMLS CUI 2011AA
C0039231
SNOMED CT 2011_0131
3424008
MedDRA 14.1
10019303
ICD-10-CM Version 2010
R00.0
ICD-9-CM Version 2011
785.0
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
CL435382
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
kongestive Herzinsuffizienz
Beschreibung

Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
Uncontrolled hypertension
Beschreibung

Uncontrolled arterial hypertension

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
Uncontrolled asthma
Beschreibung

Uncontrolled asthma

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0004096
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
Nierenerkrankung
Beschreibung

Renal disease

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
Renal insufficiency defined as glomerular filtration rate (GRF) <50 ml/min/1.73 m (estimated GRF according to Cockcroft-Gault)
Beschreibung

Renal insufficiency defined as glomerular filtration rate (GRF) <50 ml/min/1.73 m (estimated GRF according to Cockcroft-Gault)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10022467
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
Psychiatrische Erkrankung
Beschreibung

Psychiatric illness

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
Known or suspected immunodeficiency
Beschreibung

Known or suspected immunodeficiency

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0021051
SNOMED CT 2011_0131
234532001
MedDRA 14.1
10061598
ICD-10-CM Version 2010
D84.9
ICD-9-CM Version 2011
279.3
Laboratory abnormalities: hemoglobin <8.5 g/dl, white blood cell count <3500/mm, platelet count <125 000/mm, clinically relevant elevation of liver enzymes, serum creatinine level >=1.4 mg/dl, hematuria (>=10 erythrocytes/field on dipsticks)
Beschreibung

Laboratory abnormalities: hemoglobin <8.5 g/dl, white blood cell count <3500/mm, platelet count <125 000/mm, clinically relevant elevation of liver enzymes, serum creatinine level >=1.4 mg/dl, hematuria (>=10 erythrocytes/field on dipsticks)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0857093
MedDRA 14.1
10014480
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0018965
SNOMED CT 2011_0131
34436003
MedDRA 14.1
10018867
ICD-10-CM Version 2010
R31
ICD-9-CM Version 2011
599.7
CTCAE 1105E
E13000
Pregnancy, lactation
Beschreibung

Pregnancy, lactation

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
History of alcohol and/or drug dependence
Beschreibung

History of alcohol and/or drug dependence

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0085762
starker Raucher (mehr als 20 pro Tag)
Beschreibung

Heavy smoking (> 20 cigarettes per day)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0337669
SNOMED CT 2011_0131
56771006
Use of prohibited drugs or treatments
Beschreibung

Use of prohibited drugs or treatments

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
Patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems
Beschreibung

Patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0457432
SNOMED CT 2011_0131
258143003
UMLS CUI 2011AA
C0680734
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0520817
SNOMED CT 2011_0131
32572006
MedDRA 14.1
10048624
UMLS CUI 2011AA
C1306341
SNOMED CT 2011_0131
47437004
MedDRA 14.1
10027374
ICD-10-CM Version 2010
F79
UMLS CUI 2011AA
C0023015
SNOMED CT 2011_0131
62305002
ICD-10-CM Version 2010
F80.9
Participation in another investigational drug or vaccine trial within the last three months or concurrently with this study
Beschreibung

Participation in another investigational drug or vaccine trial within the last three months or concurrently with this study

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0042210
SNOMED CT 2011_0131
71181003
LOINC Version 232
MTHU014526
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Vaccination with life attenuated viruses within 4 weeks prior to study start
Beschreibung

Vaccination with life attenuated viruses within 4 weeks prior to study start

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0042196
SNOMED CT 2011_0131
33879002
MedDRA 14.1
10046859
LOINC Version 232
MTHU000146
UMLS CUI 2011AA
C1516086
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial
Beschreibung

Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patients possibly dependent on the investigator or the sponsor
Beschreibung

Patients possibly dependent on the investigator or the sponsor

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
CL414916
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C2347796
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
Age 18 Years to 70 Years
Item
Alter 18 bis 70 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Established diagnosis of CD, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
Item
Established diagnosis of CD, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C2828392 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0041618 (UMLS CUI 2011AA)
16310003 (SNOMED CT 2011_0131)
10065594 (MedDRA 14.1)
MTHU000076 (LOINC Version 232)
12 (HL7 V3 2006_05)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
Patients must be in clinical remission (Crohn's Disease Activity Index [CDAI] <150 points) on steroid therapy for at least 2 weeks
Item
Patients must be in clinical remission (Crohn's Disease Activity Index [CDAI] <150 points) on steroid therapy for at least 2 weeks
boolean
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
Confirmed steroid-dependency of CD: patients who are either
Item
Confirmed steroid-dependency of CD: patients who are either
boolean
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
CL414916 (UMLS CUI 2011AA)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
Item
unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
boolean
C0038317 (UMLS CUI 2011AA)
who have a relapse within 2 months of stopping steroids
Item
who have a relapse within 2 months of stopping steroids
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1947925 (UMLS CUI 2011AA)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose
Item
Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose
boolean
C0449864 (UMLS CUI 2011AA)
118589004 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week
Item
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Established diagnosis of UC, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
Item
Established diagnosis of UC, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
C2828392 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0041618 (UMLS CUI 2011AA)
16310003 (SNOMED CT 2011_0131)
10065594 (MedDRA 14.1)
MTHU000076 (LOINC Version 232)
12 (HL7 V3 2006_05)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
Patients must be in clinical remission (Clinical Activity Index [CAI] <4 points) on steroid therapy for at least 2 weeks
Item
Patients must be in clinical remission (Clinical Activity Index [CAI] <4 points) on steroid therapy for at least 2 weeks
boolean
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose
Item
Individual threshold dose of previous relapses should be <= 20 mg/day Prednisolone or equivalent steroid dose
boolean
C0449864 (UMLS CUI 2011AA)
118589004 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week (* The threshold dose is that dose at which the patient experienced the relapses)
Item
Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week (* The threshold dose is that dose at which the patient experienced the relapses)
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Negative pregnancy test at screening in females of child-bearing potential
Item
Negative pregnancy test at screening in females of child-bearing potential
boolean
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
Males willing to use condoms or to be sexually abstinent
Item
Males willing to use condoms or to be sexually abstinent
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
Use of appropriate contraceptive methods for females of childbearing potential one month before, throughout the course of the study and one month after study termination. This must be a combination of the following:
Item
Use of appropriate contraceptive methods for females of childbearing potential one month before, throughout the course of the study and one month after study termination. This must be a combination of the following:
boolean
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
a highly effective method of first choice = a method with a low failure rate (i.e. < 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some Intra Uterine Devices (IUDs), vasectomized partner together with
Item
a highly effective method of first choice = a method with a low failure rate (i.e. < 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some Intra Uterine Devices (IUDs), vasectomized partner together with
boolean
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
a method of second choice like condom, diaphragm, or cup pessary
Item
a method of second choice like condom, diaphragm, or cup pessary
boolean
C0677582 (UMLS CUI 2011AA)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0031246 (UMLS CUI 2011AA)
46625003 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Short bowel syndrome
Item
Syndrom des kurzen Darms
boolean
C0036992 (UMLS CUI 2011AA)
26629001 (SNOMED CT 2011_0131)
10049416 (MedDRA 14.1)
Ileostomy, colostomy or rectal pouch
Item
Ileostomy, colostomy or rectal pouch
boolean
C0020883 (UMLS CUI 2011AA)
173977007 (SNOMED CT 2011_0131)
10021321 (MedDRA 14.1)
46.20 (ICD-9-CM Version 2011)
C0009410 (UMLS CUI 2011AA)
398740003 (SNOMED CT 2011_0131)
10010041 (MedDRA 14.1)
46.10 (ICD-9-CM Version 2011)
C0939964 (UMLS CUI 2011AA)
Relapse during screening
Item
Relapse during screening
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
History of or existence of active tuberculosis
Item
History of or existence of active tuberculosis
boolean
C0375796 (UMLS CUI 2011AA)
Z86.11 (ICD-10-CM Version 2010)
V12.01 (ICD-9-CM Version 2011)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
History of or existence of urolithiasis
Item
History of or existence of urolithiasis
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0451641 (UMLS CUI 2011AA)
95566004 (SNOMED CT 2011_0131)
10046707 (MedDRA 14.1)
N20-N23 (ICD-10-CM Version 2010)
History of or existence of human immune deficiency virus (HIV), Hepatitis B or C
Item
History of or existence of human immune deficiency virus (HIV), Hepatitis B or C
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C1997078 (UMLS CUI 2011AA)
429721005 (SNOMED CT 2011_0131)
History of malignancy within the past five years (excluding basal cell carcinoma of the skin)
Item
History of malignancy within the past five years (excluding basal cell carcinoma of the skin)
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
Previous opportunistic infection
Item
Previous opportunistic infection
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0029118 (UMLS CUI 2011AA)
61274003 (SNOMED CT 2011_0131)
10030901 (MedDRA 14.1)
History of serious drug sensitivity
Item
History of serious drug sensitivity
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0237865 (UMLS CUI 2011AA)
419511003 (SNOMED CT 2011_0131)
Significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ECG)
Item
Significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ECG)
boolean
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0428977 (UMLS CUI 2011AA)
48867003 (SNOMED CT 2011_0131)
10006093 (MedDRA 14.1)
R00.1 (ICD-10-CM Version 2010)
C0039231 (UMLS CUI 2011AA)
3424008 (SNOMED CT 2011_0131)
10019303 (MedDRA 14.1)
R00.0 (ICD-10-CM Version 2010)
785.0 (ICD-9-CM Version 2011)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
CL435382 (UMLS CUI 2011AA)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
Congestive heart failure
Item
kongestive Herzinsuffizienz
boolean
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
Uncontrolled arterial hypertension
Item
Uncontrolled hypertension
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
Uncontrolled asthma
Item
Uncontrolled asthma
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Renal disease
Item
Nierenerkrankung
boolean
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
Renal insufficiency defined as glomerular filtration rate (GRF) <50 ml/min/1.73 m (estimated GRF according to Cockcroft-Gault)
Item
Renal insufficiency defined as glomerular filtration rate (GRF) <50 ml/min/1.73 m (estimated GRF according to Cockcroft-Gault)
boolean
C1565489 (UMLS CUI 2011AA)
10022467 (MedDRA 14.1)
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
Psychiatric illness
Item
Psychiatrische Erkrankung
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
Known or suspected immunodeficiency
Item
Known or suspected immunodeficiency
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0021051 (UMLS CUI 2011AA)
234532001 (SNOMED CT 2011_0131)
10061598 (MedDRA 14.1)
D84.9 (ICD-10-CM Version 2010)
279.3 (ICD-9-CM Version 2011)
Laboratory abnormalities: hemoglobin <8.5 g/dl, white blood cell count <3500/mm, platelet count <125 000/mm, clinically relevant elevation of liver enzymes, serum creatinine level >=1.4 mg/dl, hematuria (>=10 erythrocytes/field on dipsticks)
Item
Laboratory abnormalities: hemoglobin <8.5 g/dl, white blood cell count <3500/mm, platelet count <125 000/mm, clinically relevant elevation of liver enzymes, serum creatinine level >=1.4 mg/dl, hematuria (>=10 erythrocytes/field on dipsticks)
boolean
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0857093 (UMLS CUI 2011AA)
10014480 (MedDRA 14.1)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0018965 (UMLS CUI 2011AA)
34436003 (SNOMED CT 2011_0131)
10018867 (MedDRA 14.1)
R31 (ICD-10-CM Version 2010)
599.7 (ICD-9-CM Version 2011)
E13000 (CTCAE 1105E)
Pregnancy, lactation
Item
Pregnancy, lactation
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
History of alcohol and/or drug dependence
Item
History of alcohol and/or drug dependence
boolean
C0085762 (UMLS CUI 2011AA)
Heavy smoking (> 20 cigarettes per day)
Item
starker Raucher (mehr als 20 pro Tag)
boolean
C0337669 (UMLS CUI 2011AA)
56771006 (SNOMED CT 2011_0131)
Use of prohibited drugs or treatments
Item
Use of prohibited drugs or treatments
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems
Item
Patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems
boolean
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C0520817 (UMLS CUI 2011AA)
32572006 (SNOMED CT 2011_0131)
10048624 (MedDRA 14.1)
C1306341 (UMLS CUI 2011AA)
47437004 (SNOMED CT 2011_0131)
10027374 (MedDRA 14.1)
F79 (ICD-10-CM Version 2010)
C0023015 (UMLS CUI 2011AA)
62305002 (SNOMED CT 2011_0131)
F80.9 (ICD-10-CM Version 2010)
Participation in another investigational drug or vaccine trial within the last three months or concurrently with this study
Item
Participation in another investigational drug or vaccine trial within the last three months or concurrently with this study
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0042210 (UMLS CUI 2011AA)
71181003 (SNOMED CT 2011_0131)
MTHU014526 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Vaccination with life attenuated viruses within 4 weeks prior to study start
Item
Vaccination with life attenuated viruses within 4 weeks prior to study start
boolean
C0042196 (UMLS CUI 2011AA)
33879002 (SNOMED CT 2011_0131)
10046859 (MedDRA 14.1)
MTHU000146 (LOINC Version 232)
C1516086 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial
Item
Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients possibly dependent on the investigator or the sponsor
Item
Patients possibly dependent on the investigator or the sponsor
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
CL414916 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
C2347796 (UMLS CUI 2011AA)
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