ID

43063

Description

ODM derived from http://clinicaltrials.gov/show/NCT01194219

Lien

http://clinicaltrials.gov/show/NCT01194219

Mots-clés

  1. 19/03/2013 19/03/2013 - Martin Dugas
  2. 19/04/2014 19/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

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Licence

Creative Commons BY 4.0

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Eligibility NCT01194219 Plaque Psoriasis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alter mindestens 18 Jahre
Description

age at least 18 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Males or females, ≥ 18 years of age at the time of signing the informed consent document
Description

Males or females, ≥ 18 years of age at the time of signing the informed consent document

Type de données

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C2348583
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
Description

Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0406317
SNOMED CT 2011_0131
200965009
ICD-10-CM Version 2010
L40.0
Have moderate to severe plaque psoriasis at Screening and Baseline
Description

Have moderate to severe plaque psoriasis at Screening and Baseline

Type de données

boolean

Alias
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
UMLS CUI 2011AA
C0406317
SNOMED CT 2011_0131
200965009
ICD-10-CM Version 2010
L40.0
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1442488
Must meet all laboratory criteria
Description

Must meet all laboratory criteria

Type de données

boolean

Alias
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
CL414621
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
Description

Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication

Type de données

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0348078
SNOMED CT 2011_0131
246176004
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.
Description

Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0042387
SNOMED CT 2011_0131
22523008
MedDRA 14.1
10047133
ICD-9-CM Version 2011
63.73
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0023115
SNOMED CT 2011_0131
400664008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0032616
SNOMED CT 2011_0131
255781002
Ausschlusskriterien
Description

Ausschlusskriterien

Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
Description

Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.

Type de données

boolean

Alias
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Pregnant or breast feeding
Description

Pregnant or breast feeding

Type de données

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
History of allergy to any component of the study drug
Description

History of allergy to any component of the study drug

Type de données

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Hepatitis B surface antigen positive at Screening
Description

Hepatitis B surface antigen positive at Screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0149709
SNOMED CT 2011_0131
165806002
MedDRA 14.1
10019742
UMLS CUI 2011AA
C1409616
Anti-hepatitis C antibody positive at Screening
Description

Anti-hepatitis C antibody positive at Screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
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
CL415097
UMLS CUI 2011AA
C1409616
Active tuberculosis (TB) or a history of incompletely treated TB
Description

Active tuberculosis (TB) or a history of incompletely treated TB

Type de données

boolean

Alias
UMLS CUI 2011AA
C0151332
SNOMED CT 2011_0131
427099000
MedDRA 14.1
10071157
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205257
SNOMED CT 2011_0131
255599008
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.1
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
Clinically significant abnormality on 12-Lead ECG at Screening
Description

Clinically significant abnormality on 12-Lead ECG at Screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0522055
SNOMED CT 2011_0131
102594003
MedDRA 14.1
10014363
UMLS CUI 2011AA
C1409616
Clinically significant abnormal chest x-ray
Description

Clinically significant abnormal chest x-ray

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0436503
SNOMED CT 2011_0131
168734001
MedDRA 14.1
10008499
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
Description

History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0853602
MedDRA 14.1
10021450
UMLS CUI 2011AA
C0596032
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Description

Active substance abuse or a history of substance abuse within 6 months prior to Screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C1299544
SNOMED CT 2011_0131
371435006
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
Description

Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0004623
SNOMED CT 2011_0131
87628006
MedDRA 14.1
10060945
ICD-10-CM Version 2010
A49.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0559681
SNOMED CT 2011_0131
281791007
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
Description

Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0334245
SNOMED CT 2011_0131
59529006
MedDRA 14.1
10022782
UMLS CUI 2011AA
C0206708
SNOMED CT 2011_0131
285636001
MedDRA 14.1
10056576
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
Psoriasis flare or rebound within 4 weeks prior to Screening
Description

Psoriasis flare or rebound within 4 weeks prior to Screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0235763
MedDRA 14.1
10037156
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
Evidence of skin conditions that would interfere with clinical assessments
Description

Evidence of skin conditions that would interfere with clinical assessments

Type de données

boolean

Alias
UMLS CUI 2011AA
C1719933
SNOMED CT 2011_0131
422000003
LOINC Version 232
MTHU034830
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C1516048
Topical therapy within 2 weeks of randomization
Description

Topical therapy within 2 weeks of randomization

Type de données

boolean

Alias
UMLS CUI 2011AA
C0150349
SNOMED CT 2011_0131
386439008
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0034656
Systemic therapy for psoriasis within 4 weeks prior to randomization
Description

Systemic therapy for psoriasis within 4 weeks prior to randomization

Type de données

boolean

Alias
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
Description

Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0031765
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
Description

Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization

Type de données

boolean

Alias
UMLS CUI 2011AA
C1122087
SNOMED CT 2011_0131
407317001
UMLS CUI 2011AA
C0717758
SNOMED CT 2011_0131
387045004
UMLS CUI 2011AA
C0666743
SNOMED CT 2011_0131
386891004
LOINC Version 232
MTHU018219
UMLS CUI 2011AA
C1172157
SNOMED CT 2011_0131
430307008
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
Description

Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization

Type de données

boolean

Alias
UMLS CUI 2011AA
C0962603
SNOMED CT 2011_0131
398691006
UMLS CUI 2011AA
C2744325
UMLS CUI 2011AA
C1608841
SNOMED CT 2011_0131
443644001
Use of any investigational drug within 4 weeks prior to randomization
Description

Use of any investigational drug within 4 weeks prior to randomization

Type de données

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0013230
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Description

Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources

Type de données

boolean

Alias
UMLS CUI 2011AA
C0439590
SNOMED CT 2011_0131
255224006
UMLS CUI 2011AA
C1456711
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0183827
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0041625
SNOMED CT 2011_0131
41355003
UMLS CUI 2011AA
C0449416
SNOMED CT 2011_0131
260753009
Prior treatment with apremilast
Description

Prior treatment with apremilast

Type de données

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1678805

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males or females, ≥ 18 years of age at the time of signing the informed consent document
Item
Males or females, ≥ 18 years of age at the time of signing the informed consent document
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C2348583 (UMLS CUI 2011AA)
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
Item
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0406317 (UMLS CUI 2011AA)
200965009 (SNOMED CT 2011_0131)
L40.0 (ICD-10-CM Version 2010)
Have moderate to severe plaque psoriasis at Screening and Baseline
Item
Have moderate to severe plaque psoriasis at Screening and Baseline
boolean
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0406317 (UMLS CUI 2011AA)
200965009 (SNOMED CT 2011_0131)
L40.0 (ICD-10-CM Version 2010)
C1409616 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
Must meet all laboratory criteria
Item
Must meet all laboratory criteria
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL414621 (UMLS CUI 2011AA)
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
Item
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0348078 (UMLS CUI 2011AA)
246176004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.
Item
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0023115 (UMLS CUI 2011AA)
400664008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0032616 (UMLS CUI 2011AA)
255781002 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
Item
Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
boolean
CL411789 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Pregnant or breast feeding
Item
Pregnant or breast feeding
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
History of allergy to any component of the study drug
Item
History of allergy to any component of the study drug
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C1705248 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Hepatitis B surface antigen positive at Screening
Item
Hepatitis B surface antigen positive at Screening
boolean
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Anti-hepatitis C antibody positive at Screening
Item
Anti-hepatitis C antibody positive at Screening
boolean
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
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)
CL415097 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
Active tuberculosis (TB) or a history of incompletely treated TB
Item
Active tuberculosis (TB) or a history of incompletely treated TB
boolean
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
Clinically significant abnormality on 12-Lead ECG at Screening
Item
Clinically significant abnormality on 12-Lead ECG at Screening
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0522055 (UMLS CUI 2011AA)
102594003 (SNOMED CT 2011_0131)
10014363 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Clinically significant abnormal chest x-ray
Item
Clinically significant abnormal chest x-ray
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0436503 (UMLS CUI 2011AA)
168734001 (SNOMED CT 2011_0131)
10008499 (MedDRA 14.1)
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
Item
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0853602 (UMLS CUI 2011AA)
10021450 (MedDRA 14.1)
C0596032 (UMLS CUI 2011AA)
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Item
Active substance abuse or a history of substance abuse within 6 months prior to Screening
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C1299544 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
Item
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
boolean
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0559681 (UMLS CUI 2011AA)
281791007 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
Item
Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL415147 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0334245 (UMLS CUI 2011AA)
59529006 (SNOMED CT 2011_0131)
10022782 (MedDRA 14.1)
C0206708 (UMLS CUI 2011AA)
285636001 (SNOMED CT 2011_0131)
10056576 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
Psoriasis flare or rebound within 4 weeks prior to Screening
Item
Psoriasis flare or rebound within 4 weeks prior to Screening
boolean
C0235763 (UMLS CUI 2011AA)
10037156 (MedDRA 14.1)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
Evidence of skin conditions that would interfere with clinical assessments
Item
Evidence of skin conditions that would interfere with clinical assessments
boolean
C1719933 (UMLS CUI 2011AA)
422000003 (SNOMED CT 2011_0131)
MTHU034830 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
Topical therapy within 2 weeks of randomization
Item
Topical therapy within 2 weeks of randomization
boolean
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (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)
C0034656 (UMLS CUI 2011AA)
Systemic therapy for psoriasis within 4 weeks prior to randomization
Item
Systemic therapy for psoriasis within 4 weeks prior to randomization
boolean
C1515119 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
Item
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
boolean
C0031765 (UMLS CUI 2011AA)
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
Item
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
boolean
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
C0717758 (UMLS CUI 2011AA)
387045004 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C1172157 (UMLS CUI 2011AA)
430307008 (SNOMED CT 2011_0131)
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
Item
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
boolean
C0962603 (UMLS CUI 2011AA)
398691006 (SNOMED CT 2011_0131)
C2744325 (UMLS CUI 2011AA)
C1608841 (UMLS CUI 2011AA)
443644001 (SNOMED CT 2011_0131)
Use of any investigational drug within 4 weeks prior to randomization
Item
Use of any investigational drug within 4 weeks prior to randomization
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Item
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
boolean
C0439590 (UMLS CUI 2011AA)
255224006 (SNOMED CT 2011_0131)
C1456711 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0183827 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0041625 (UMLS CUI 2011AA)
41355003 (SNOMED CT 2011_0131)
C0449416 (UMLS CUI 2011AA)
260753009 (SNOMED CT 2011_0131)
Prior treatment with apremilast
Item
Prior treatment with apremilast
boolean
C1514463 (UMLS CUI 2011AA)
C1678805 (UMLS CUI 2011AA)

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