ID

44621

Description

ODM derived from http://clinicaltrials.gov/show/NCT01092533

Link

http://clinicaltrials.gov/show/NCT01092533

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01092533 Non-infectious Intermediate Uveitis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 80 Years
Description

age 18 Years to 80 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects with a documented at least 6 months history of unilateral or bilateral intermediate uveitis either idiopathic or due to non-infectious systemic disease (e.g. sarcoidosis, multiple sclerosis)
Description

Subjects with a documented at least 6 months history of unilateral or bilateral intermediate uveitis either idiopathic or due to non-infectious systemic disease (e.g. sarcoidosis, multiple sclerosis)

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0238767
SNOMED CT 2011_0131
51440002
UMLS CUI 2011AA
C0042166
SNOMED CT 2011_0131
314429009
MedDRA 14.1
10022557
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332240
SNOMED CT 2011_0131
54690008
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0442893
SNOMED CT 2011_0131
56019007, 264578000
UMLS CUI 2011AA
C0036202
SNOMED CT 2011_0131
31541009
MedDRA 14.1
10039486
ICD-10-CM Version 2010
D86.9
ICD-9-CM Version 2011
135
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
Uveitis has to be considered to be active at the timepoint of enrolment according to at least one of the following criteria:
Description

Uveitis has to be considered to be active at the timepoint of enrolment according to at least one of the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C0042164
Grade 2+ or higher for vitreous haze
Description

Grade 2+ or higher for vitreous haze

Data type

boolean

Alias
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C0152006
SNOMED CT 2011_0131
422061002
MedDRA 14.1
10047658
Grade 2+ or higher for anterior chamber cells
Description

Grade 2+ or higher for anterior chamber cells

Data type

boolean

Alias
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C0423282
SNOMED CT 2011_0131
246993000
MedDRA 14.1
10053781
Presence of cystoid macular edema in OCT
Description

Presence of cystoid macular edema in OCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0024440
SNOMED CT 2011_0131
193387007
MedDRA 14.1
10058202
UMLS CUI 2011AA
C0920367
SNOMED CT 2011_0131
392010000
MedDRA 14.1
10057208
Presence of retinal vessel leakage in FA
Description

Presence of retinal vessel leakage in FA

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0035330
SNOMED CT 2011_0131
28758002
UMLS CUI 2011AA
C0015376
SNOMED CT 2011_0131
76676007
MedDRA 14.1
10015866
UMLS CUI 2011AA
C0016313
SNOMED CT 2011_0131
172581008
Considered by the investigator to require systemic treatment.
Description

Considered by the investigator to require systemic treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1515119
Not planning to undergo elective ocular surgery during the study
Description

Not planning to undergo elective ocular surgery during the study

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0439608
SNOMED CT 2011_0131
103390000
UMLS CUI 2011AA
C1705869
SNOMED CT 2011_0131
422191005
Capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements
Description

Capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Subjects of both gender with reproductive potential who are sexually active agree to use contraception throughout the course of the study and for at least 3 months after completion of their study participation.
Description

Subjects of both gender with reproductive potential who are sexually active agree to use contraception throughout the course of the study and for at least 3 months after completion of their study participation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1706086
UMLS CUI 2011AA
C0079399
SNOMED CT 2011_0131
263495000
LOINC Version 232
MTHU002975
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal IUDs combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner.
Description

Women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal IUDs combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0458083
SNOMED CT 2011_0131
278994005
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0037862
SNOMED CT 2011_0131
425484006
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Women of childbearing age must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and must not be lactating.
Description

Women of childbearing age must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and must not be lactating.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C2826207
Female subjects of non-childbearing potential must meet at least one of the following criteria:
Description

Female subjects of non-childbearing potential must meet at least one of the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Postmenopausal females, defined as:
Description

Postmenopausal females, defined as:

Data type

boolean

Alias
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1704788
Females over the age of 60 years.
Description

Females over the age of 60 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Females who are 45 to 60 years of age must be amenorrheic for at least 2 years.
Description

Females who are 45 to 60 years of age must be amenorrheic for at least 2 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0002453
SNOMED CT 2011_0131
14302001
MedDRA 14.1
10001928
ICD-10-CM Version 2010
N91.2
ICD-9-CM Version 2011
626.0
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Females who had a hysterectomy and/or bilateral oophorectomy.
Description

Females who had a hysterectomy and/or bilateral oophorectomy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0020699
SNOMED CT 2011_0131
236886002
MedDRA 14.1
10021151
UMLS CUI 2011AA
C0278321
SNOMED CT 2011_0131
76876009
MedDRA 14.1
10030339
ICD-9-CM Version 2011
65.51
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Uveitis of infectious etiology
Description

Uveitis of infectious etiology

Data type

boolean

Alias
UMLS CUI 2011AA
C0042164
Signs of tuberculosis in chest x-ray during the past 12 months before study entry
Description

Signs of tuberculosis in chest x-ray during the past 12 months before study entry

Data type

boolean

Alias
UMLS CUI 2011AA
C0220912
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
UMLS CUI 2011AA
C0039985
SNOMED CT 2011_0131
399208008
MedDRA 14.1
10008498
Clinically suspected or confirmed central nervous system or ocular lymphoma
Description

Clinically suspected or confirmed central nervous system or ocular lymphoma

Data type

boolean

Alias
UMLS CUI 2011AA
C0280803
SNOMED CT 2011_0131
307649006
MedDRA 14.1
10007953
ICD-9-CM Version 2011
200.5
UMLS CUI 2011AA
C1706527
SNOMED CT 2011_0131
420788006
Primary diagnosis of anterior or posterior uveitis
Description

Primary diagnosis of anterior or posterior uveitis

Data type

boolean

Alias
UMLS CUI 2011AA
C0801658
LOINC Version 232
18630-4
UMLS CUI 2011AA
C0042165
SNOMED CT 2011_0131
410692006
MedDRA 14.1
10046852
UMLS CUI 2011AA
C0042167
SNOMED CT 2011_0131
43363007
MedDRA 14.1
10036370
Uncontrolled glaucoma or known steroid response
Description

Uncontrolled glaucoma or known steroid response

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0017601
SNOMED CT 2011_0131
23986001
MedDRA 14.1
10018304
LOINC Version 232
MTHU020819
ICD-10-CM Version 2010
H40-H42
ICD-9-CM Version 2011
365
CTCAE 1105E
E10392
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0871261
Subjects who received treatment with a systemic immunosuppressive drug, a monoclonal antibody or any other biologic therapy within 90 days prior study entry
Description

Subjects who received treatment with a systemic immunosuppressive drug, a monoclonal antibody or any other biologic therapy within 90 days prior study entry

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C0005527
Treatment with mycophenolate mofetil or mycophenolate sodium in the past
Description

Treatment with mycophenolate mofetil or mycophenolate sodium in the past

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0209368
SNOMED CT 2011_0131
386976000
UMLS CUI 2011AA
C1337395
SNOMED CT 2011_0131
426216009
Treatment with a periocular steroid injection within 6 weeks prior to study entry
Description

Treatment with a periocular steroid injection within 6 weeks prior to study entry

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1444677
SNOMED CT 2011_0131
410563000
Presence of absolute contraindications for Decortin H and/or Myfortic as mentioned in the product informations (Appendix 1 and 2)
Description

Presence of absolute contraindications for Decortin H and/or Myfortic as mentioned in the product informations (Appendix 1 and 2)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205344
SNOMED CT 2011_0131
56136002
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
C0026933
SNOMED CT 2011_0131
409330005
Presence of relative contraindications for Decortin H and/or Myfortic as mentioned in the product information (Appendix 1 and 2) if the disorder leading to the relative contraindication can not sufficiently managed by concomitant medication.
Description

Presence of relative contraindications for Decortin H and/or Myfortic as mentioned in the product information (Appendix 1 and 2) if the disorder leading to the relative contraindication can not sufficiently managed by concomitant medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205345
SNOMED CT 2011_0131
29920004
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
C0026933
SNOMED CT 2011_0131
409330005
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205410
SNOMED CT 2011_0131
51117008
UMLS CUI 2011AA
CL415147
Recipients of a solid organ transplant
Description

Recipients of a solid organ transplant

Data type

boolean

Alias
UMLS CUI 2011AA
C1709854
UMLS CUI 2011AA
C0730400
SNOMED CT 2011_0131
313039003
Subjects with lens opacities or obscured ocular media upon enrolment making unable evaluation of the posterior eye segment
Description

Subjects with lens opacities or obscured ocular media upon enrolment making unable evaluation of the posterior eye segment

Data type

boolean

Alias
UMLS CUI 2011AA
C1510497
SNOMED CT 2011_0131
193570009
MedDRA 14.1
10024214
UMLS CUI 2011AA
CL427838
UMLS CUI 2011AA
C1299003
UMLS CUI 2011AA
C0522503
SNOMED CT 2011_0131
300828005
UMLS CUI 2011AA
C0439861
SNOMED CT 2011_0131
105590001
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0278450
SNOMED CT 2011_0131
280659009
Subjects with a history of herpes zoster or varicella infection within 3 months before enrollment
Description

Subjects with a history of herpes zoster or varicella infection within 3 months before enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019360
SNOMED CT 2011_0131
4740000
MedDRA 14.1
10019974
ICD-10-CM Version 2010
B02
ICD-9-CM Version 2011
53
UMLS CUI 2011AA
C0008049
SNOMED CT 2011_0131
38907003
MedDRA 14.1
10046980
ICD-10-CM Version 2010
B01
ICD-9-CM Version 2011
52
Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the history/presence of active hepatitis A, B or C
Description

Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the history/presence of active hepatitis A, B or C

Data type

boolean

Alias
UMLS CUI 2011AA
C0241886
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1136254
SNOMED CT 2011_0131
250428009
LOINC Version 232
MTHU014499
UMLS CUI 2011AA
C0019159
SNOMED CT 2011_0131
40468003
MedDRA 14.1
10019780
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
HIV Seropositivity
Description

Seropositivity for human immunodeficiency virus (HIV)

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) >= 2x upper limit of normal (ULN)
Description

Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) >= 2x upper limit of normal (ULN)

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0017040
SNOMED CT 2011_0131
60153001
LOINC Version 232
MTHU001941
UMLS CUI 2011AA
C1519815
Severe anemia (hemoglobin < 8 g/dL), leukopenia (white blood cell count [WBC] < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3)
Description

Severe anemia (hemoglobin < 8 g/dL), leukopenia (white blood cell count [WBC] < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0002871
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C0023530
SNOMED CT 2011_0131
84828003
MedDRA 14.1
10024384
ICD-10-CM Version 2010
D72.819
ICD-9-CM Version 2011
288.50
CTCAE 1105E
E12232
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0040034
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
Malignant Neoplasms
Description

Current malignancy or a history of malignancy within the previous 5 years

Data type

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
Pregnant or lactating women
Description

Pregnant or lactating women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Known allergy for fluorescein natrium
Description

Known allergy for fluorescein natrium

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1618612
SNOMED CT 2011_0131
25351006
Currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent
Description

Currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C1709277
UMLS CUI 2011AA
C0879626
SNOMED CT 2011_0131
281647001
MedDRA 14.1
10067484
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0013230
Subjects with non-ocular, medically significant co-morbid conditions that impair normal activities, require systemic corticosteroids or immunosuppressives, or any medical condition that would likely have an impact on the participant´s ability to comply with the study visit schedule
Description

Subjects with non-ocular, medically significant co-morbid conditions that impair normal activities, require systemic corticosteroids or immunosuppressives, or any medical condition that would likely have an impact on the participant´s ability to comply with the study visit schedule

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1299003
UMLS CUI 2011AA
C1275743
SNOMED CT 2011_0131
398192003
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C1280500
SNOMED CT 2011_0131
253861007
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0525058
Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication
Description

Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication

Data type

boolean

Alias
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
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
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C0009452
SNOMED CT 2011_0131
263536004
LOINC Version 232
MTHU021752
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 80 Years
Item
age 18 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects with a documented at least 6 months history of unilateral or bilateral intermediate uveitis either idiopathic or due to non-infectious systemic disease (e.g. sarcoidosis, multiple sclerosis)
Item
Subjects with a documented at least 6 months history of unilateral or bilateral intermediate uveitis either idiopathic or due to non-infectious systemic disease (e.g. sarcoidosis, multiple sclerosis)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
C0042166 (UMLS CUI 2011AA)
314429009 (SNOMED CT 2011_0131)
10022557 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332240 (UMLS CUI 2011AA)
54690008 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0036202 (UMLS CUI 2011AA)
31541009 (SNOMED CT 2011_0131)
10039486 (MedDRA 14.1)
D86.9 (ICD-10-CM Version 2010)
135 (ICD-9-CM Version 2011)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Uveitis has to be considered to be active at the timepoint of enrolment according to at least one of the following criteria:
Item
Uveitis has to be considered to be active at the timepoint of enrolment according to at least one of the following criteria:
boolean
C0042164 (UMLS CUI 2011AA)
Grade 2+ or higher for vitreous haze
Item
Grade 2+ or higher for vitreous haze
boolean
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C0152006 (UMLS CUI 2011AA)
422061002 (SNOMED CT 2011_0131)
10047658 (MedDRA 14.1)
Grade 2+ or higher for anterior chamber cells
Item
Grade 2+ or higher for anterior chamber cells
boolean
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C0423282 (UMLS CUI 2011AA)
246993000 (SNOMED CT 2011_0131)
10053781 (MedDRA 14.1)
Presence of cystoid macular edema in OCT
Item
Presence of cystoid macular edema in OCT
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0024440 (UMLS CUI 2011AA)
193387007 (SNOMED CT 2011_0131)
10058202 (MedDRA 14.1)
C0920367 (UMLS CUI 2011AA)
392010000 (SNOMED CT 2011_0131)
10057208 (MedDRA 14.1)
Presence of retinal vessel leakage in FA
Item
Presence of retinal vessel leakage in FA
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0035330 (UMLS CUI 2011AA)
28758002 (SNOMED CT 2011_0131)
C0015376 (UMLS CUI 2011AA)
76676007 (SNOMED CT 2011_0131)
10015866 (MedDRA 14.1)
C0016313 (UMLS CUI 2011AA)
172581008 (SNOMED CT 2011_0131)
Considered by the investigator to require systemic treatment.
Item
Considered by the investigator to require systemic treatment.
boolean
C1514873 (UMLS CUI 2011AA)
C1515119 (UMLS CUI 2011AA)
Not planning to undergo elective ocular surgery during the study
Item
Not planning to undergo elective ocular surgery during the study
boolean
C1518422 (UMLS CUI 2011AA)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0439608 (UMLS CUI 2011AA)
103390000 (SNOMED CT 2011_0131)
C1705869 (UMLS CUI 2011AA)
422191005 (SNOMED CT 2011_0131)
Capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements
Item
Capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements
boolean
C0021430 (UMLS CUI 2011AA)
Subjects of both gender with reproductive potential who are sexually active agree to use contraception throughout the course of the study and for at least 3 months after completion of their study participation.
Item
Subjects of both gender with reproductive potential who are sexually active agree to use contraception throughout the course of the study and for at least 3 months after completion of their study participation.
boolean
C0681850 (UMLS CUI 2011AA)
C1706086 (UMLS CUI 2011AA)
C0079399 (UMLS CUI 2011AA)
263495000 (SNOMED CT 2011_0131)
MTHU002975 (LOINC Version 232)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal IUDs combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner.
Item
Women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal IUDs combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Women of childbearing age must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and must not be lactating.
Item
Women of childbearing age must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and must not be lactating.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C2826207 (UMLS CUI 2011AA)
Female subjects of non-childbearing potential must meet at least one of the following criteria:
Item
Female subjects of non-childbearing potential must meet at least one of the following criteria:
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Postmenopausal females, defined as:
Item
Postmenopausal females, defined as:
boolean
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1704788 (UMLS CUI 2011AA)
Females over the age of 60 years.
Item
Females over the age of 60 years.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Females who are 45 to 60 years of age must be amenorrheic for at least 2 years.
Item
Females who are 45 to 60 years of age must be amenorrheic for at least 2 years.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0002453 (UMLS CUI 2011AA)
14302001 (SNOMED CT 2011_0131)
10001928 (MedDRA 14.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Females who had a hysterectomy and/or bilateral oophorectomy.
Item
Females who had a hysterectomy and/or bilateral oophorectomy.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0278321 (UMLS CUI 2011AA)
76876009 (SNOMED CT 2011_0131)
10030339 (MedDRA 14.1)
65.51 (ICD-9-CM Version 2011)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Uveitis of infectious etiology
Item
Uveitis of infectious etiology
boolean
C0042164 (UMLS CUI 2011AA)
Signs of tuberculosis in chest x-ray during the past 12 months before study entry
Item
Signs of tuberculosis in chest x-ray during the past 12 months before study entry
boolean
C0220912 (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)
C0039985 (UMLS CUI 2011AA)
399208008 (SNOMED CT 2011_0131)
10008498 (MedDRA 14.1)
Clinically suspected or confirmed central nervous system or ocular lymphoma
Item
Clinically suspected or confirmed central nervous system or ocular lymphoma
boolean
C0280803 (UMLS CUI 2011AA)
307649006 (SNOMED CT 2011_0131)
10007953 (MedDRA 14.1)
200.5 (ICD-9-CM Version 2011)
C1706527 (UMLS CUI 2011AA)
420788006 (SNOMED CT 2011_0131)
Primary diagnosis of anterior or posterior uveitis
Item
Primary diagnosis of anterior or posterior uveitis
boolean
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C0042165 (UMLS CUI 2011AA)
410692006 (SNOMED CT 2011_0131)
10046852 (MedDRA 14.1)
C0042167 (UMLS CUI 2011AA)
43363007 (SNOMED CT 2011_0131)
10036370 (MedDRA 14.1)
Uncontrolled glaucoma or known steroid response
Item
Uncontrolled glaucoma or known steroid response
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
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)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0871261 (UMLS CUI 2011AA)
Subjects who received treatment with a systemic immunosuppressive drug, a monoclonal antibody or any other biologic therapy within 90 days prior study entry
Item
Subjects who received treatment with a systemic immunosuppressive drug, a monoclonal antibody or any other biologic therapy within 90 days prior study entry
boolean
C0039798 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0005527 (UMLS CUI 2011AA)
Treatment with mycophenolate mofetil or mycophenolate sodium in the past
Item
Treatment with mycophenolate mofetil or mycophenolate sodium in the past
boolean
C0039798 (UMLS CUI 2011AA)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C1337395 (UMLS CUI 2011AA)
426216009 (SNOMED CT 2011_0131)
Treatment with a periocular steroid injection within 6 weeks prior to study entry
Item
Treatment with a periocular steroid injection within 6 weeks prior to study entry
boolean
C0039798 (UMLS CUI 2011AA)
C1444677 (UMLS CUI 2011AA)
410563000 (SNOMED CT 2011_0131)
Presence of absolute contraindications for Decortin H and/or Myfortic as mentioned in the product informations (Appendix 1 and 2)
Item
Presence of absolute contraindications for Decortin H and/or Myfortic as mentioned in the product informations (Appendix 1 and 2)
boolean
C0205344 (UMLS CUI 2011AA)
56136002 (SNOMED CT 2011_0131)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
C0026933 (UMLS CUI 2011AA)
409330005 (SNOMED CT 2011_0131)
Presence of relative contraindications for Decortin H and/or Myfortic as mentioned in the product information (Appendix 1 and 2) if the disorder leading to the relative contraindication can not sufficiently managed by concomitant medication.
Item
Presence of relative contraindications for Decortin H and/or Myfortic as mentioned in the product information (Appendix 1 and 2) if the disorder leading to the relative contraindication can not sufficiently managed by concomitant medication.
boolean
C0205345 (UMLS CUI 2011AA)
29920004 (SNOMED CT 2011_0131)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
C0026933 (UMLS CUI 2011AA)
409330005 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0205410 (UMLS CUI 2011AA)
51117008 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
Recipients of a solid organ transplant
Item
Recipients of a solid organ transplant
boolean
C1709854 (UMLS CUI 2011AA)
C0730400 (UMLS CUI 2011AA)
313039003 (SNOMED CT 2011_0131)
Subjects with lens opacities or obscured ocular media upon enrolment making unable evaluation of the posterior eye segment
Item
Subjects with lens opacities or obscured ocular media upon enrolment making unable evaluation of the posterior eye segment
boolean
C1510497 (UMLS CUI 2011AA)
193570009 (SNOMED CT 2011_0131)
10024214 (MedDRA 14.1)
CL427838 (UMLS CUI 2011AA)
C1299003 (UMLS CUI 2011AA)
C0522503 (UMLS CUI 2011AA)
300828005 (SNOMED CT 2011_0131)
C0439861 (UMLS CUI 2011AA)
105590001 (SNOMED CT 2011_0131)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C0278450 (UMLS CUI 2011AA)
280659009 (SNOMED CT 2011_0131)
Subjects with a history of herpes zoster or varicella infection within 3 months before enrollment
Item
Subjects with a history of herpes zoster or varicella infection within 3 months before enrollment
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0008049 (UMLS CUI 2011AA)
38907003 (SNOMED CT 2011_0131)
10046980 (MedDRA 14.1)
B01 (ICD-10-CM Version 2010)
52 (ICD-9-CM Version 2011)
Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the history/presence of active hepatitis A, B or C
Item
Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the history/presence of active hepatitis A, B or C
boolean
C0241886 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C0019159 (UMLS CUI 2011AA)
40468003 (SNOMED CT 2011_0131)
10019780 (MedDRA 14.1)
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)
Seropositivity for human immunodeficiency virus (HIV)
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) >= 2x upper limit of normal (ULN)
Item
Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) >= 2x upper limit of normal (ULN)
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0017040 (UMLS CUI 2011AA)
60153001 (SNOMED CT 2011_0131)
MTHU001941 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Severe anemia (hemoglobin < 8 g/dL), leukopenia (white blood cell count [WBC] < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3)
Item
Severe anemia (hemoglobin < 8 g/dL), leukopenia (white blood cell count [WBC] < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0023530 (UMLS CUI 2011AA)
84828003 (SNOMED CT 2011_0131)
10024384 (MedDRA 14.1)
D72.819 (ICD-10-CM Version 2010)
288.50 (ICD-9-CM Version 2011)
E12232 (CTCAE 1105E)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Current malignancy or a history of malignancy within the previous 5 years
Item
Malignant Neoplasms
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)
Pregnant or lactating women
Item
Pregnant or lactating women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Known allergy for fluorescein natrium
Item
Known allergy for fluorescein natrium
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1618612 (UMLS CUI 2011AA)
25351006 (SNOMED CT 2011_0131)
Currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent
Item
Currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent
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)
C0013230 (UMLS CUI 2011AA)
C1709277 (UMLS CUI 2011AA)
C0879626 (UMLS CUI 2011AA)
281647001 (SNOMED CT 2011_0131)
10067484 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
Subjects with non-ocular, medically significant co-morbid conditions that impair normal activities, require systemic corticosteroids or immunosuppressives, or any medical condition that would likely have an impact on the participant´s ability to comply with the study visit schedule
Item
Subjects with non-ocular, medically significant co-morbid conditions that impair normal activities, require systemic corticosteroids or immunosuppressives, or any medical condition that would likely have an impact on the participant´s ability to comply with the study visit schedule
boolean
C1518422 (UMLS CUI 2011AA)
C1299003 (UMLS CUI 2011AA)
C1275743 (UMLS CUI 2011AA)
398192003 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication
Item
Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication
boolean
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
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)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C1883420 (UMLS CUI 2011AA)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
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