ID

10875

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00299923 Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

Link

http://clinicaltrials.gov/show/NCT00299923

Stichworte

Klinische Studie [Dokumenttyp]

Hepatitis C

Behandlungsbedürftigkeit, Begutachtung

Hochgeladen am

11. Juni 2015

DOI

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Lizenz

Creative Commons BY 4.0

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Hepatitis C Eligibility NCT00299923

Modell
Details

Eligibility Hepatitis C, Chronic Relapse NCT00299923

1 Formulare

StudyEvent: Eligibility
1. Eligibility Hepatitis C, Chronic Relapse NCT00299923

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Inclusion Criteria

Item Group

Einschlusskriterien

C1512693 (UMLS CUI-1)

Age

Item

Alter 18 Jahre und älter

boolean

C0001779 (UMLS CUI-1)

Relapsers to combination therapy with negative HCV-RNA test result at treatment's end and positive HCV-RNA test result during follow-up

Item

boolean

C0277556 (UMLS CUI-1)
C0556895 (UMLS CUI-2)
C0369335 (UMLS CUI-3)

Termination of (PEG-)IFN alfa-/ribavirin therapy

Item

Termination of (PEG-)IFN alfa-/ribavirin therapy at least 3 months prior to enrolment

boolean

HCV infection genotype 1 or 3

Item

Chronic HCV infection genotype 1 or 3

boolean

quantitative HCV-RNA PCR test

Item

Serum HCV-RNA quantifiable at >100 IU/mL by COBAS AmpliPrep or another quantitative HCV-RNA PCR test (reported in IU)

boolean

liver disease (Child-Pugh A)

Item

Compensated liver disease (Child-Pugh A)

boolean

Exclusion of HCC in patients with cirrhosis

Item

Exclusion of HCC in patients with cirrhosis or transition to cirrhosis. In patients with AFP >50 ng/mL an established assay for exclusion of HCC has to be done

boolean

Negative pregnancy test

Item

Negative urine or blood pregnancy test

boolean

fertile males and females use two forms of contraception

Item

All fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months post treatment

boolean

Exclusion Criteria

Item Group

Ausschlusskriterien

C0680251 (UMLS CUI-1)

Hypersensitiveness to ingredient of the drugs

Item

Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs

boolean

pregnancy or breast feeding

Item

Ongoing pregnancy or breast feeding

boolean

Male partners of women who are pregnant or without contraception

Item

Male partners of women who are pregnant or with women without effective contraception

boolean

hepatocellular carcinoma

Item

Signs or symptoms of hepatocellular carcinoma

boolean

HCV infection genotype 2, 4, 5 or 6

Item

Chronic HCV infection genotype 2, 4, 5 or 6

boolean

Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment. Exception: patients who have had a limited course of acyclovir or valacyclovir for herpetic lesions.

Item

Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment < 6 months prior to the first dose of study drug and during study period. Exception: patients who have had a limited (< 7 days) course of acyclovir or valacyclovir for herpetic lesions < 1 month prior to the first administration of test drug are not excluded.

boolean

investigational drug < 6 weeks prior to the study drug

Item

Any investigational drug < 6 weeks prior to the first dose of study drug

boolean

Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV

Item

Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV

boolean

chronic liver disease other than HCV

Item

History or other evidence of a medical condition associated with chronic liver disease other than HCV

boolean

decompensated liver disease or Child-Pugh score > 6

Item

History or other evidence of decompensated liver disease or a Child-Pugh score > 6.

boolean

Hemoglobin low

Item

Hb <12 g/dL bei Frauen oder <13 g/dL bei Männern beim Screening

boolean

C0162119 (UMLS CUI-1)

patient with risk for anemia or for whom anemia would be problematic

Item

Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic

boolean

Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3

Item

Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3

boolean

Serum creatinin concentration >1.5 mg/dl

Item

Serum creatinin concentration >1.5 mg/dl

boolean

severe psychiatric disease

Item

History of severe psychiatric disease, especially depression.

boolean

seizure disorder not stabilizable by medication

Item

History of a severe seizure disorder that can not be stabilized by medication

boolean

immunologically mediated disease

Item

History of immunologically mediated disease

boolean

Chronic pulmonary disease

Item

Chronic pulmonary disease associated with functional limitation

boolean

severe cardiac disease

Item

History of severe cardiac disease

boolean

major organ transplantation except corneatransplantation

Item

History of major organ transplantation except corneatransplantation

boolean

severe illness, malignancy, or any other conditions which would make the patient unsuitable for the study

Item

Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

boolean

Thyroid dysfunction not adequately controlled

Item

Thyroid dysfunction not adequately controlled

boolean

severe retinopathy or ophthalmological disorder due to diabetes mellitus or hypertension

Item

Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension

boolean

active drug abuse

Item

Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution

boolean

Take of Memantine

Item

Take of Memantine during study period

boolean

Cardiomyopathy and myocarditis

Item

Cardiomyopathy and myocarditis

boolean

AV-Block II and III

Item

AV-Block II and III

boolean

bradycardia < 55 counts/min

Item

Pre-existing bradycardia < 55 counts/min

boolean

QT-interval or U-waves or QT-syndrome

Item

Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome

boolean

severe ventricular arrhythmia

Item

History of severe ventricular arrhythmia incl. Torsade de pointes

boolean

Simultaneous therapy with Budipin or other medicine that extend the QT-interval

Item

Simultaneous therapy with Budipin or other medicine that extend the QT-interval like (e.g.antiarrhythmic drugs class IA and class III, antipsychotic drugs, tri- and tetracyclic antidepressants, antihistaminics, macrolide, gyrase inhibitors, Azol-antimykotics)

boolean

obstructive glaucoma

Item

Patients with obstructive glaucoma

boolean

excitableness and confusion

Item

Patients with excitableness and confusion

boolean

delirium and exogenic psychosis in the anamnesis

Item

Patients with delirium and exogenic psychosis in the anamnesis

boolean

Prostataadenome

Item

Prostataadenome

boolean

medication of type combination Triamterene/ Hydrochlorothiazide

Item

Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide

boolean

lack of informed consent or of abidance by the study requirements

Item

Inability or unwillingness to provide informed consent or abide by the requirements of the study

boolean

Medical Concepts

Item Group

Medizinische Konzepte

PEG

Item

Polyethylene Glycols

string

C0032483 (UMLS CUI)
8030004 (SNOMED CT 2010_0731)

IFN Alpha

Item

Interferon-alpha, IFN-alpha

string

C1610033 (UMLS CUI)

Ribavirin

Item

Ribavirin

string

C0035525 (UMLS CUI)
387188005 (SNOMED CT 2010_0731)
MTHU018696 (LOINC Version 232)

HCV RNA

Item

Hepatitis C virus RNA (substance)

string

C0369335 (UMLS CUI)
121204002 (SNOMED CT 2010_0731)
MTHU001816 (LOINC Version 232)

Test

Item

Test

string

C0392366 (UMLS CUI)
C47891 (SNOMED CT 2010_0731)

Negative

Item

negativ

string

CL415098 (UMLS CUI)

Therapy

Item

Therapie

string

C0087111 (UMLS CUI)

positive

Item

positiv

string

CL415097 (UMLS CUI)

Follow-up

Item

Follow-up

string

C1522577 (UMLS CUI)

Period

Item

Period (temporal concept)

string

C1948053 (UMLS CUI)

Enrollment

Item

Registrierung

string

C2348568 (UMLS CUI)

HCV

Item

Hepatitis-C-Virus

string

C0220847 (UMLS CUI)
62944002 (SNOMED CT 2010_0731)
10019752 (MedDRA 13.1)

chronic

Item

chronisch

string

C0205191 (UMLS CUI)
90734009 (SNOMED CT 2010_0731)

Infection

Item

Infektion

string

C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)

Genotype

Item

Genotyp

string

C0017431 (UMLS CUI)

Serum

Item

Serum

string

C0229671 (UMLS CUI)
67922002 (SNOMED CT 2010_0731)
MTHU001009 (LOINC Version 232)

Item

internationale Einheit, IE

string

C0439453 (UMLS CUI)
258997004 (SNOMED CT 2010_0731)
[IU] (HL7 V3 02-34)

PCR

Item

Polymerase-Kettenreaktion

string

C0032520 (UMLS CUI)
258066000 (SNOMED CT 2010_0731)
10050967 (MedDRA 13.1)
132 (HL7 V3 02-34)

Quantitative

Item

quantitativ

string

C0392762 (UMLS CUI)
30766002 (SNOMED CT 2010_0731)

Liver disorder

Item

Lebererkrankung

string

C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)

Child-Pugh Classification

Item

Child-Pugh Score

string

C2347612 (UMLS CUI)

HCC

Item

Leberzellkarzinom

string

C0019204 (UMLS CUI)
10049010 (MedDRA 13.1)

Hepatic Cirrhosis

Item

Leberzirrhose

string

C0023890 (UMLS CUI)
19943007 (SNOMED CT 2010_0731)
10019641 (MedDRA 13.1)
K74.60 (ICD-10-CM Version 2010)

AFP measurement

Item

Alpha-Fetoprotein

string

C0201539 (UMLS CUI)
80152001 (SNOMED CT 2010_0731)
10001455 (MedDRA 13.1)

Assay

Item

Assay

string

C1510438 (UMLS CUI)
272392009 (SNOMED CT 2010_0731)

Urine pregnancy test negative

Item

Urine pregnancy test negative

string

C0430057 (UMLS CUI)
167254001 (SNOMED CT 2010_0731)
10036577 (MedDRA 13.1)

Negative Pregnancy Test

Item

negativer Schwangerschaftstest

string

C0427780 (UMLS CUI)
250425007 (SNOMED CT 2010_0731)
10036574 (MedDRA 13.1)

blood

Item

Blut

string

C0005768 (UMLS CUI)

Fertile

Item

fertil

string

CL426012 (UMLS CUI)

Male

Item

maskulin, männlich

string

C0024554 (UMLS CUI)

Female

Item

feminin, weiblich

string

C0015780 (UMLS CUI)

Contraception

Item

Kontrazeption

string

C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)

Hypersensitivity

Item

Allergic reaction to substance

string

C0020517 (UMLS CUI)
418634005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)

Interferons

Item

Interferon, IFN

string

C0021747 (UMLS CUI)
49327004 (SNOMED CT 2010_0731)
MTHU021353 (LOINC Version 232)

peginterferon alfa-2a

Item

Peginterferon alpha-2a (substance)

string

C0391001 (UMLS CUI)
421559001 (SNOMED CT 2010_0731)

Amantadine

Item

Amantadin

string

C0002403 (UMLS CUI)
372763006 (SNOMED CT 2010_0731)
MTHU006774 (LOINC Version 232)

Pharmaceutical Preparations

Item

Medikation

string

C0013227 (UMLS CUI)

Pregnancy

Item

Schwangerschaft

string

C0549206 (UMLS CUI)
289908002 (SNOMED CT 2010_0731)
10036556 (MedDRA 13.1)
MTHU035048 (LOINC Version 232)

pregnant

Item

schwanger

string

C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)

Lactation

Item

Stillzeit

string

C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)

signs

Item

signs

string

C0220912 (UMLS CUI)

Symptoms

Item

Symptom

string

C1457887 (UMLS CUI)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)

Systemic Therapy

Item

Systemische Therapie

string

C1515119 (UMLS CUI)

Antiviral treatment

Item

Antiviral treatment

string

C2363964 (UMLS CUI)
10068724 (MedDRA 13.1)

antineoplastic Immunotherapy

Item

Immunotherapy, antineoplastic

string

C0864561 (UMLS CUI)

Immunomodulatory or immunosuppressive therapy

Item

Immunomodulatory or immunosuppressive therapy

string

C1963758 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
10067473 (MedDRA 13.1)

Acyclovir

Item

Acyclovir

string

C0001367 (UMLS CUI)
372729009 (SNOMED CT 2010_0731)
MTHU006764 (LOINC Version 232)

Valaciclovir

Item

Valacyclovir

string

C0249458 (UMLS CUI)
96098007 (SNOMED CT 2010_0731)

Herpes dermatitis

Item

eczema herpeticum

string

C1262170 (UMLS CUI)
10062639 (MedDRA 13.1)

Investigational Drug

Item

Investigational New Drug

string

C0013230 (UMLS CUI)

HAV

Item

Hepatitis-A-Virus, HAV

string

C0376325 (UMLS CUI)
32452004 (SNOMED CT 2010_0731)

IgM

Item

Immunglobulin, IgM

string

C0020861 (UMLS CUI)
74889000 (SNOMED CT 2010_0731)
MTHU004563 (LOINC Version 232)

HBsAg

Item

Hepatitis-B-Oberflächenantigen

string

C0019168 (UMLS CUI)
22290004 (SNOMED CT 2010_0731)
MTHU001814 (LOINC Version 232)

HBc IgM

Item

Hepatitis B core IgM level

string

C1277836 (UMLS CUI)
315132007 (SNOMED CT 2010_0731)

HIV

Item

HIV-Virus

string

C0019699 (UMLS CUI)
19030005 (SNOMED CT 2010_0731)

Decompensated Liver Disease

Item

End Stage Liver Disease

string

C0745744 (UMLS CUI)
10050060 (MedDRA 13.1)

man

Item

Mann

string

C0025266 (UMLS CUI)
339947000 (SNOMED CT 2010_0731)

Woman

Item

Frau

string

C0043210 (UMLS CUI)
224526002 (SNOMED CT 2010_0731)

disorder risk

Item

disease risk

string

C0683481 (UMLS CUI)

Anemia

Item

Anämie

string

C0002871 (UMLS CUI)
271737000 (SNOMED CT 2010_0731)
10002034 (MedDRA 13.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE Version 4.03)

Baseline

Item

Baseline

string

C1442488 (UMLS CUI)

Neutrophil count

Item

Neutrophil count (procedure)

string

C0200633 (UMLS CUI)
30630007 (SNOMED CT 2010_0731)
10029363 (MedDRA 13.1)

Platelet count

Item

Thrombozyten

string

C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)

Serum Creatinine

Item

Kreatinin im Serum

string

C0201976 (UMLS CUI)
113075003 (SNOMED CT 2010_0731)
10040230 (MedDRA 13.1)

Concentration

Item

Concentration

string

C1446561 (UMLS CUI)

Mental disorders

Item

Psychiatric disorder

string

C0004936 (UMLS CUI)
74732009 (SNOMED CT 2010_0731)
10037174 (MedDRA 13.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)

Depressive disorder

Item

Depression

string

C0011581 (UMLS CUI)
35489007 (SNOMED CT 2010_0731)
10012401 (MedDRA 13.1)
F32.9 (ICD-10-CM Version 2010)

Epilepsy

Item

Epilepsia

string

C0014544 (UMLS CUI)
84757009 (SNOMED CT 2010_0731)
10015037 (MedDRA 13.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)

Stabilization

Item

Stabilisierung

string

C1293130 (UMLS CUI)
115979005 (SNOMED CT 2010_0731)

Immunotherapy

Item

Immunotherapy

string

C0021083 (UMLS CUI)
146638005 (SNOMED CT 2010_0731)

Pulmonary disease

Item

Lungenerkrankung

string

C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)

Limitation

Item

Limitation

string

C0449295 (UMLS CUI)
246175000 (SNOMED CT 2010_0731)

Functional Status

Item

Functional Status, Level of function

string

C0598463 (UMLS CUI)
MTHU027728 (LOINC Version 232)

Cardiac disease

Item

Herzkrankheit

string

C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)

Organ Transplantation

Item

Organtransplantation

string

C0029216 (UMLS CUI)
10061890 (MedDRA 13.1)
MTHU000173 (LOINC Version 232)

Major

Item

Major (qualifier value)

string

C0205164 (UMLS CUI)
255603008 (SNOMED CT 2010_0731)

Keratoplasty

Item

Keratoplastik, Hornhauttransplantation

string

C0010042 (UMLS CUI)
60656008 (SNOMED CT 2010_0731)
10054846 (MedDRA 13.1)
11.60 (ICD-9-CM Version 2011)

Disease

Item

disorder

string

C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)

Cancer

Item

Krebs

string

C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)

Thyroid dysfunction

Item

Thyroid dysfunction

string

C0348024 (UMLS CUI)
264580006 (SNOMED CT 2010_0731)
10013907 (MedDRA 13.1)

Retinopathy

Item

Retinopathy

string

C0035309 (UMLS CUI)
399625000 (SNOMED CT 2010_0731)
10038923 (MedDRA 13.1)
E10432 (CTCAE Version 4.03)

Disorder of eye

Item

Ophthalmological disorder

string

C0015397 (UMLS CUI)
371405004 (SNOMED CT 2010_0731)
10015916 (MedDRA 13.1)
H44 (ICD-10-CM Version 2010)
379.90 (ICD-9-CM Version 2011)

Diabetes mellitus

Item

Diabetes mellitus

string

C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)

Hypertension

Item

Hypertonie

string

C0020538 (UMLS CUI)
38341003 (SNOMED CT 2010_0731)
10020772 (MedDRA 13.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE Version 4.03)

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)

Active

Item

aktiv

string

C0205177 (UMLS CUI)
55561003 (SNOMED CT 2010_0731)

Prescriptions

Item

Prescription (procedure)

string

C0033080 (UMLS CUI)
16076005 (SNOMED CT 2010_0731)

Opioid Rotation

Item

Opioid Substitution

string

C1518592 (UMLS CUI)

Stable status

Item

Stability

string

C0205360 (UMLS CUI)
58158008 (SNOMED CT 2010_0731)
MTHU015276 (LOINC Version 232)

Memantine

Item

Memantine (substance)

string

C0025242 (UMLS CUI)
406458000 (SNOMED CT 2010_0731)
MTHU035864 (LOINC Version 232)

Take

Item

Take- dosing instruction imperative (qualifier value)

string

C1515187 (UMLS CUI)
419652001 (SNOMED CT 2010_0731)

Cardiomyopathy

Item

Kardiomyopathie

string

C0878544 (UMLS CUI)
85898001 (SNOMED CT 2010_0731)
10007636 (MedDRA 13.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)

Myocarditis

Item

Myokarditis

string

C0027059 (UMLS CUI)
50920009 (SNOMED CT 2010_0731)
10028606 (MedDRA 13.1)
I51.4 (ICD-10-CM Version 2010)
429.0 (ICD-9-CM Version 2011)
E10157 (CTCAE Version 4.03)

AV Block

Item

AV-Block

string

C0004245 (UMLS CUI)
233917008 (SNOMED CT 2010_0731)
10003671 (MedDRA 13.1)
I44.30 (ICD-10-CM Version 2010)
426.10 (ICD-9-CM Version 2011)

Bradycardia

Item

Bradykardie

string

C0428977 (UMLS CUI)
48867003 (SNOMED CT 2010_0731)
10006093 (MedDRA 13.1)
R00.1 (ICD-10-CM Version 2010)

QTC interval

Item

QTC interval

string

C0489625 (UMLS CUI)
MTHU024527 (LOINC Version 232)

QT interval - finding

Item

Finding of ECG QT interval (finding)

string

C1287082 (UMLS CUI)
365417009 (SNOMED CT 2010_0731)

U Waves

Item

U-Welle

string

C0232333 (UMLS CUI)
39438000 (SNOMED CT 2010_0731)
10045281 (MedDRA 13.1)

Syndrome

Item

Syndrom

string

C0039082 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)

congenital

Item

kongenital

string

C0009678 (UMLS CUI)

Ventricular arrhythmia

Item

Ventrikuläre Arrhythmie

string

C0085612 (UMLS CUI)
44103008 (SNOMED CT 2010_0731)
10047281 (MedDRA 13.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE Version 4.03)

Torsades de Pointes

Item

Ventricular tachycardia, polymorphic with Q-T prolongation

string

C0040479 (UMLS CUI)
31722008 (SNOMED CT 2010_0731)
10044066 (MedDRA 13.1)

Simultaneous

Item

simultan

string

C0521115 (UMLS CUI)
79970003 (SNOMED CT 2010_0731)

Budipine

Item

1-(1,1-Dimethylethyl)-4,4-diphenylpiperidine

string

C0054202 (UMLS CUI)

Antiarrhythmic drug

Item

Antiarrhythmic drug

string

C0003195 (UMLS CUI)
67507000 (SNOMED CT 2010_0731)

Antipsychotic Agent

Item

Antipsychotika

string

C0040615 (UMLS CUI)
372482001 (SNOMED CT 2010_0731)
MTHU003337 (LOINC Version 232)

Tricyclic antidepressant

Item

trizyklisches Antidepressivum

string

C0003290 (UMLS CUI)
373253007 (SNOMED CT 2010_0731)
MTHU001920 (LOINC Version 232)

Tetracyclic antidepressant

Item

tetrazyklisches Antidepressivum

string

C0360108 (UMLS CUI)
372576002 (SNOMED CT 2010_0731)

Antihistamines

Item

Antihistaminikum

string

C0003360 (UMLS CUI)
372806008 (SNOMED CT 2010_0731)
MTHU003328 (LOINC Version 232)

Macrolides

Item

Makrolid

string

C0282563 (UMLS CUI)
428787002 (SNOMED CT 2010_0731)

DNA Gyrase Inhibitors

Item

Gyraseinhibitor

string

C2936780 (UMLS CUI)

Azole antifungal

Item

Azole antifungal (substance)

string

C0360363 (UMLS CUI)
373236000 (SNOMED CT 2010_0731)

Glaucoma

Item

Glaukom

string

C0017601 (UMLS CUI)
23986001 (SNOMED CT 2010_0731)
10018304 (MedDRA 13.1)
MTHU020819 (LOINC Version 232)
H40-H42 (ICD-10-CM Version 2010)
365 (ICD-9-CM Version 2011)
E10392 (CTCAE Version 4.03)

obstructive glaucoma

Item

Engwinkelglaukom

string

C0017605 (UMLS CUI)
392291006 (SNOMED CT 2010_0731)
10002500 (MedDRA 13.1)

Excitable

Item

Excitable

string

C0857393 (UMLS CUI)
10015623 (MedDRA 13.1)

Confusion

Item

Konfusion

string

C0009676 (UMLS CUI)
286933003 (SNOMED CT 2010_0731)
10010305 (MedDRA 13.1)
MTHU019384 (LOINC Version 232)
R41.0 (ICD-10-CM Version 2010)
E12889 (CTCAE Version 4.03)

Delirium

Item

Delirium

string

C0011206 (UMLS CUI)
2776000 (SNOMED CT 2010_0731)
10012218 (MedDRA 13.1)
MTHU031955 (LOINC Version 232)
R41.0 (ICD-10-CM Version 2010)
E12898 (CTCAE Version 4.03)

Psychotic Disorders

Item

Psychose

string

C0033975 (UMLS CUI)
69322001 (SNOMED CT 2010_0731)
10061920 (MedDRA 13.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE Version 4.03)

exogen

Item

exogen

string

C1752469 (UMLS CUI)

Anamnesis

Item

Anamnese

string

C0021055 (UMLS CUI)
940000 (SNOMED CT 2010_0731)

Prostatic Hyperplasia

Item

Prostatahyperplasie, Prostata-Adenom

string

C2937421 (UMLS CUI)
433234005 (SNOMED CT 2010_0731)
10020728 (MedDRA 13.1)
N40 (ICD-10-CM Version 2010)
600 (ICD-9-CM Version 2011)

Diuretic

Item

Diuretikum

string

C0012798 (UMLS CUI)
372695000 (SNOMED CT 2010_0731)
MTHU003217 (LOINC Version 232)

Triamterene

Item

Triamteren

string

C0040869 (UMLS CUI)
387053007 (SNOMED CT 2010_0731)
MTHU001919 (LOINC Version 232)

Hydrochlorothiazide

Item

Hydrochlorothiazid

string

C0020261 (UMLS CUI)
387525002 (SNOMED CT 2010_0731)
MTHU016732 (LOINC Version 232)

Informed Consent

Item

Einverständniserklärung

string

C0021430 (UMLS CUI)

Requirement

Item

Erfordernis

string

C1514873 (UMLS CUI)

Study

Item

Studie

string

C0008976 (UMLS CUI)
110465008 (SNOMED CT 2010_0731)

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Modell Kommentare :

Itemgroup Kommentare für :

Item Kommentare für :

Hepatitis C Eligibility NCT00299923

Eligibility Hepatitis C, Chronic Relapse NCT00299923

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