ID

10672

Beschreibung

Eligibility NCT00221000 Rheumatoid Arthritis Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis (RA-1) ODM derived from http://clinicaltrials.gov/show/NCT00221000

Link

http://clinicaltrials.gov/show/NCT00221000

Stichworte

Versionen (3)
  1. 10.02.12 10.02.12 -
  2. 13.04.14 13.04.14 - Julian Varghese
  3. 06.06.15 06.06.15 - Martin Dugas
Hochgeladen am

6. Juni 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Rheumatoid Arthritis Photoimmune Therapy With UVADEX Eligibility NCT00221000

Deutsch Englisch

Eligibility Rheumatoid Arthritis NCT00221000

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
18 Years and older
Beschreibung

18 Years and older

Datentyp

boolean

Alias
UMLS CUI-1
C0001779
Patients must have a history of RA per the ACR criteria for the classification of RA
Beschreibung

Patients must have a history of RA per the ACR criteria for the classification of RA

Datentyp

boolean

Alias
UMLS CUI-1
C0332119
UMLS CUI-2
C0003873
Patients must have moderately to severely active RA
Beschreibung

Patients must have moderately to severely active RA

Datentyp

boolean

Alias
UMLS CUI-1
C1299393
UMLS CUI-2
C0003873
Patients who are not on oral corticosteroids OR Patients who have been on a stable dose of oral corticosteroids at a prednisone equivalent dosage greater than or equal to 15 mg/day for at least 4 weeks prior to screening.
Beschreibung

oral corticosteroids max. 15mg/day prednisone equivalent

Datentyp

boolean

Patients must have a platelet count greater than or equal to 100,000/cmm.
Beschreibung

Patients must have a platelet count greater than or equal to 100,000/cmm.

Datentyp

boolean

Alias
UMLS CUI-1
C0032181
Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods may include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening.
Beschreibung

Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods may include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening.

Datentyp

boolean

Alias
UMLS CUI-1
C0232973
Patients must be able and willing to comply with all study procedures
Beschreibung

Patients must be able and willing to comply with all study procedures

Datentyp

boolean

Alias
UMLS CUI-1
C1321605
Patients must be willing to sign an ICF
Beschreibung

Patients must be willing to sign an ICF

Datentyp

boolean

Alias
UMLS CUI-1
C0021430
Patients must have a body weight greater than or equal to 40 kg (88 lb).
Beschreibung

Patients must have a body weight greater than or equal to 40 kg (88 lb).

Datentyp

boolean

Alias
UMLS CUI-1
C0005910
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patients who have a form of arthritis or arthropathy, other than RA, or any current inflammatory condition that might confound the assessments (e.g., other connective tissue diseases or Lyme disease).
Beschreibung

other arthritis, arthropathy or inflammatory condition

Datentyp

boolean

Patients who have been enrolled in any investigational therapy study for the treatment of RA within 4 weeks prior to the start of the Treatment Period, or patients who are scheduled to receive investigational therapies or a plasma based apheresis procedure (e.g., a protein A column) for the treatment of RA during the course of the study.
Beschreibung

Patients who have been enrolled in any investigational therapy study for the treatment of RA within 4 weeks prior to the start of the Treatment Period, or patients who are scheduled to receive investigational therapies or a plasma based apheresis procedure (e.g., a protein A column) for the treatment of RA during the course of the study.

Datentyp

boolean

Alias
UMLS CUI-1
C2348568
Patients unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure.
Beschreibung

ECP not possible

Datentyp

boolean

Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
Beschreibung

Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.

Datentyp

boolean

Alias
UMLS CUI-1
C0190979
UMLS CUI-2
C0332218
Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen)
Beschreibung

Allergy to psoralen

Datentyp

boolean

Patients who have a known hypersensitivity or allergy to both heparin and citrate products
Beschreibung

Allergy to heparin or citrate products

Datentyp

boolean

Patients who are taking any of the following permitted DMARDs and biological agents and have not been on a stable dose for the specific indicated periods of time prior to screening: MTX for at least 8 weeks; leflunomide for at least 8 weeks; infliximab for at least 14 weeks; etanercept for at least 12 weeks; adalimumab for at least 12 weeks
Beschreibung

no stable dose for DMARDs

Datentyp

boolean

Patients who are taking any of the following permitted medications and have not been on a stable dose for at least 4 weeks prior to screening: NSAIDs; anakinra; hydroxychloroquine; chloroquine; sulfasalazine; D-penicillamine; gold salts; azathioprine; oral corticosteroids (greater than or equal to 15 mg/day, prednisone equivalent dose).
Beschreibung

no stable dose for NSAIDs, anakinra, D-penicillamine, gold salts, azathioprine, oral corticosteroids

Datentyp

boolean

Patients whom the Investigator believes cannot be maintained on stable doses of permitted concomitant RA medications throughout the Treatment Period
Beschreibung

no stable concomitant RA medications

Datentyp

boolean

Patients who are taking any of the following prohibited medications: cyclophosphamide; chlorambucil; intramuscular (IM) or intravenous (IV) corticosteroid injection(s), within 4 weeks of screening; intra-articular corticosteroid injection(s) > 60 mg prednisone equivalent total dose, within 4 weeks of screening
Beschreibung

prohibited: cyclophosphamide, chlorambucil, corticosteroid injections

Datentyp

boolean

Patients who have any known malignant disease (other than basal cell carcinoma) currently or within the last 5 years
Beschreibung

Patients who have any known malignant disease (other than basal cell carcinoma) currently or within the last 5 years

Datentyp

boolean

Alias
UMLS CUI-1
C0445120
Patients who have a pre-existing blood dyscrasia such as bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia, or a coagulation disorder
Beschreibung

blood dyscrasia

Datentyp

boolean

Patients with a persistent or severe infection within 12 weeks of screening.
Beschreibung

persistent or severe infection

Datentyp

boolean

Patients with a history of drug or alcohol abuse within 12 weeks of screening.
Beschreibung

Patients with a history of drug or alcohol abuse within 12 weeks of screening.

Datentyp

boolean

Alias
UMLS CUI-1
C0237123
Patients with impaired hepatic function at screening as shown by abnormal liver function tests (LFT; i.e., aspartate transaminase [AST] or alanine transaminase [ALT] levels > 2 x the upper limit of normal [ULN])
Beschreibung

impaired hepatic function

Datentyp

boolean

Women who are pregnant or lactating
Beschreibung

Women who are pregnant or lactating

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
UMLS CUI-2
C0006147
Medical Concepts
Beschreibung

Medical Concepts

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Rheumatoid Arthritis
Beschreibung

RA

Datentyp

string

Alias
UMLS CUI
C0003873
SNOMED CT 2010_0731
69896004
MedDRA 13.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
Moderately
Beschreibung

Moderate

Datentyp

string

Alias
UMLS CUI
C1881878
C-Reactive Protein Measurement
Beschreibung

CRP

Datentyp

string

Alias
UMLS CUI
C0201657
SNOMED CT 2010_0731
55235003
MedDRA 13.1
10006824
Medication
Beschreibung

Medication

Datentyp

text

Alias
UMLS CUI-1
C0013227
Methotrexate
Beschreibung

MTX

Datentyp

string

Alias
UMLS CUI
C0025677
SNOMED CT 2010_0731
387381009
LOINC Version 232
MTHU005020
Therapeutic Corticosteroid
Beschreibung

Corticosteroids

Datentyp

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
Platelet count - finding
Beschreibung

Platelet count

Datentyp

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Contraception
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Arthritis
Beschreibung

Arthritis

Datentyp

string

Alias
UMLS CUI
C0003864
SNOMED CT 2010_0731
3723001
MedDRA 13.1
10003246
LOINC Version 232
MTHU020793
ICD-10-CM Version 2010
M19.90
ICD-9-CM Version 2011
716.9
CTCAE Version 4.03
E12378
Inflammation
Beschreibung

Inflammation

Datentyp

string

Alias
UMLS CUI
C0021368
SNOMED CT 2010_0731
23583003
MedDRA 13.1
10061218
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C2348568
Chronic congestive heart failure
Beschreibung

Chronic congestive heart failure

Datentyp

string

Alias
UMLS CUI
C0264722
ICD-10-CM Version 2010
I50.0
Lung diseases
Beschreibung

Pulmonary disease

Datentyp

string

Alias
UMLS CUI
C0024115
SNOMED CT 2010_0731
19829001
MedDRA 13.1
10025082
ICD-10-CM Version 2010
J98.4
Renal Insufficiency
Beschreibung

Kidney Insufficiency

Datentyp

string

Alias
UMLS CUI
C1565489
MedDRA 13.1
10038474
Hepatic Insufficiency
Beschreibung

Liver Insufficiency

Datentyp

string

Alias
UMLS CUI
C1306571
SNOMED CT 2010_0731
59927004
MedDRA 13.1
10056542
Hypersensitivity
Beschreibung

Allergy

Datentyp

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Nonsteroidal Antiinflammatory Drug
Beschreibung

NSAID

Datentyp

string

Alias
UMLS CUI
C0003211
SNOMED CT 2010_0731
16403005
Malignant Neoplasms
Beschreibung

Cancer

Datentyp

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
White Blood Cell Count procedure (WBC)
Beschreibung

Leukocyte Count

Datentyp

string

Alias
UMLS CUI
C0023508
SNOMED CT 2010_0731
767002
MedDRA 13.1
10047939
Hemoglobin
Beschreibung

Hb

Datentyp

string

Alias
UMLS CUI
C0518015
SNOMED CT 2010_0731
38082009
MedDRA 13.1
10019481
LOINC Version 232
LP14449-0
Blood Coagulation Disorders
Beschreibung

Coagulopathy

Datentyp

string

Alias
UMLS CUI
C0005779
SNOMED CT 2010_0731
64779008
MedDRA 13.1
10009802
ICD-10-CM Version 2010
D68.9
ICD-9-CM Version 2011
286
Infection
Beschreibung

Infection

Datentyp

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Alcohol abuse
Beschreibung

Alcohol abuse

Datentyp

string

Alias
UMLS CUI
C0085762
SNOMED CT 2010_0731
15167005
MedDRA 13.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
Drug abuse
Beschreibung

Drug abuse

Datentyp

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
GOT (Serum)
Beschreibung

AST

Datentyp

string

Alias
UMLS CUI
C0004002
SNOMED CT 2010_0731
26091008
MedDRA 13.1
10003543
GPT (Serum)
Beschreibung

ALT

Datentyp

string

Alias
UMLS CUI
C0001899
SNOMED CT 2010_0731
56935002
MedDRA 13.1
10001844
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00221000

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI-1)
history of RA
Item
Patients must have a history of RA per the ACR criteria for the classification of RA
boolean
C0332119 (UMLS CUI-1)
C0003873 (UMLS CUI-2)
moderately to severely active RA
Item
Patients must have moderately to severely active RA
boolean
C1299393 (UMLS CUI-1)
C0003873 (UMLS CUI-2)
oral corticosteroids max. 15mg/day prednisone equivalent
Item
Patients who are not on oral corticosteroids OR Patients who have been on a stable dose of oral corticosteroids at a prednisone equivalent dosage greater than or equal to 15 mg/day for at least 4 weeks prior to screening.
boolean
platelet count >= 100,000
Item
Patients must have a platelet count greater than or equal to 100,000/cmm.
boolean
C0032181 (UMLS CUI-1)
no pregnancy
Item
Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods may include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening.
boolean
C0232973 (UMLS CUI-1)
Compliance
Item
Patients must be able and willing to comply with all study procedures
boolean
C1321605 (UMLS CUI-1)
Informed Consent
Item
Patients must be willing to sign an ICF
boolean
C0021430 (UMLS CUI-1)
weight >= 40kg
Item
Patients must have a body weight greater than or equal to 40 kg (88 lb).
boolean
C0005910 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
other arthritis, arthropathy or inflammatory condition
Item
Patients who have a form of arthritis or arthropathy, other than RA, or any current inflammatory condition that might confound the assessments (e.g., other connective tissue diseases or Lyme disease).
boolean
other study
Item
Patients who have been enrolled in any investigational therapy study for the treatment of RA within 4 weeks prior to the start of the Treatment Period, or patients who are scheduled to receive investigational therapies or a plasma based apheresis procedure (e.g., a protein A column) for the treatment of RA during the course of the study.
boolean
C2348568 (UMLS CUI-1)
ECP not possible
Item
Patients unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure.
boolean
Venipuncture difficult
Item
Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
boolean
C0190979 (UMLS CUI-1)
C0332218 (UMLS CUI-2)
Allergy to psoralen
Item
Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen)
boolean
Allergy to heparin or citrate products
Item
Patients who have a known hypersensitivity or allergy to both heparin and citrate products
boolean
no stable dose for DMARDs
Item
Patients who are taking any of the following permitted DMARDs and biological agents and have not been on a stable dose for the specific indicated periods of time prior to screening: MTX for at least 8 weeks; leflunomide for at least 8 weeks; infliximab for at least 14 weeks; etanercept for at least 12 weeks; adalimumab for at least 12 weeks
boolean
no stable dose for NSAIDs, anakinra, D-penicillamine, gold salts, azathioprine, oral corticosteroids
Item
Patients who are taking any of the following permitted medications and have not been on a stable dose for at least 4 weeks prior to screening: NSAIDs; anakinra; hydroxychloroquine; chloroquine; sulfasalazine; D-penicillamine; gold salts; azathioprine; oral corticosteroids (greater than or equal to 15 mg/day, prednisone equivalent dose).
boolean
no stable concomitant RA medications
Item
Patients whom the Investigator believes cannot be maintained on stable doses of permitted concomitant RA medications throughout the Treatment Period
boolean
prohibited: cyclophosphamide, chlorambucil, corticosteroid injections
Item
Patients who are taking any of the following prohibited medications: cyclophosphamide; chlorambucil; intramuscular (IM) or intravenous (IV) corticosteroid injection(s), within 4 weeks of screening; intra-articular corticosteroid injection(s) > 60 mg prednisone equivalent total dose, within 4 weeks of screening
boolean
no cancer
Item
Patients who have any known malignant disease (other than basal cell carcinoma) currently or within the last 5 years
boolean
C0445120 (UMLS CUI-1)
blood dyscrasia
Item
Patients who have a pre-existing blood dyscrasia such as bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia, or a coagulation disorder
boolean
persistent or severe infection
Item
Patients with a persistent or severe infection within 12 weeks of screening.
boolean
drug or alcohol abuse
Item
Patients with a history of drug or alcohol abuse within 12 weeks of screening.
boolean
C0237123 (UMLS CUI-1)
impaired hepatic function
Item
Patients with impaired hepatic function at screening as shown by abnormal liver function tests (LFT; i.e., aspartate transaminase [AST] or alanine transaminase [ALT] levels > 2 x the upper limit of normal [ULN])
boolean
pregnancy / lactation
Item
Women who are pregnant or lactating
boolean
C0549206 (UMLS CUI-1)
C0006147 (UMLS CUI-2)
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
RA
Item
Rheumatoid Arthritis
string
C0003873 (UMLS CUI)
69896004 (SNOMED CT 2010_0731)
10039073 (MedDRA 13.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
Moderate
Item
Moderately
string
C1881878 (UMLS CUI)
CRP
Item
C-Reactive Protein Measurement
string
C0201657 (UMLS CUI)
55235003 (SNOMED CT 2010_0731)
10006824 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
text
C0013227 (UMLS CUI-1)
MTX
Item
Methotrexate
string
C0025677 (UMLS CUI)
387381009 (SNOMED CT 2010_0731)
MTHU005020 (LOINC Version 232)
Corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Arthritis
Item
Arthritis
string
C0003864 (UMLS CUI)
3723001 (SNOMED CT 2010_0731)
10003246 (MedDRA 13.1)
MTHU020793 (LOINC Version 232)
M19.90 (ICD-10-CM Version 2010)
716.9 (ICD-9-CM Version 2011)
E12378 (CTCAE Version 4.03)
Inflammation
Item
Inflammation
string
C0021368 (UMLS CUI)
23583003 (SNOMED CT 2010_0731)
10061218 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
Chronic congestive heart failure
Item
Chronic congestive heart failure
string
C0264722 (UMLS CUI)
I50.0 (ICD-10-CM Version 2010)
Pulmonary disease
Item
Lung diseases
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
Kidney Insufficiency
Item
Renal Insufficiency
string
C1565489 (UMLS CUI)
10038474 (MedDRA 13.1)
Liver Insufficiency
Item
Hepatic Insufficiency
string
C1306571 (UMLS CUI)
59927004 (SNOMED CT 2010_0731)
10056542 (MedDRA 13.1)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
NSAID
Item
Nonsteroidal Antiinflammatory Drug
string
C0003211 (UMLS CUI)
16403005 (SNOMED CT 2010_0731)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Leukocyte Count
Item
White Blood Cell Count procedure (WBC)
string
C0023508 (UMLS CUI)
767002 (SNOMED CT 2010_0731)
10047939 (MedDRA 13.1)
Hb
Item
Hemoglobin
string
C0518015 (UMLS CUI)
38082009 (SNOMED CT 2010_0731)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC Version 232)
Coagulopathy
Item
Blood Coagulation Disorders
string
C0005779 (UMLS CUI)
64779008 (SNOMED CT 2010_0731)
10009802 (MedDRA 13.1)
D68.9 (ICD-10-CM Version 2010)
286 (ICD-9-CM Version 2011)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Alcohol abuse
Item
Alcohol abuse
string
C0085762 (UMLS CUI)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
AST
Item
GOT (Serum)
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
10003543 (MedDRA 13.1)
ALT
Item
GPT (Serum)
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
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