Eligibility Melanoma NCT00226408

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00226408
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
18 Years to 70 Years
boolean
Melanoma IIIa,b,c
Item
Histological documented cutaneous malignant melanoma Stage IIIa, IIIb, IIIc (AJCC 2002)
boolean
R0
Item
R0 resection dating back no longer than 56 days
boolean
ECOG 0-1
Item
Performance status (ECOG 0-1)
boolean
Bone marrow
Item
Bone marrow funktion: White cell count > 3000 cells/ul, platelets > 100000 cells/ul, hemoglobin > 10 g/dl
boolean
C0005953 (UMLS CUI-1)
C0023508 (UMLS CUI-2)
C0518015 (UMLS CUI-3)
Liver and kidney
Item
Liver and kidney funktion: Serum creatinin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal, Serum bilirubin < 2 times upper limit of normal
boolean
consent
Item
Written inform consent
boolean
Item Group
Exclusion Criteria
distant metastasis
Item
Confirmed distant metastasis
boolean
C0456957 (UMLS CUI-1)
Choroid or mucosal melanoma
Item
Choroid or mucosal melanoma
boolean
Pregnancy/lactation
Item
Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception
boolean
Active autoimmun disease
Item
Active autoimmun disease
boolean
patients with history of neuropsychiatric disease requiring hospitalization
Item
patients with history of neuropsychiatric disease requiring hospitalization
boolean
Severe medical conditions
Item
Severe medical condition such us: Florid hepatitis, Severe acute infection, Myocardial infarction within the past year, symptomatic angina pectoris, Grade III to IV congestive heart failure, serious pulmonary disease, HIV-positive patients with an AIDS - defining condition
boolean
other trial
Item
treatment in another clinical drug trial within the last 30 days
boolean
allergy
Item
A history of hypersensitivity to interferon alfa
boolean
other cancer
Item
History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)
boolean
prior interferon
Item
Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Melanoma
Item
Malignant melanoma
string
C0025202 (UMLS CUI)
2092003 (SNOMED CT 2010_0731)
10025650 (MedDRA 13.1)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
ECOG
Item
ECOG performance status finding
string
C1520224 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
Leukocyte Count
Item
White Blood Cell Count procedure (WBC)
string
C0023508 (UMLS CUI)
767002 (SNOMED CT 2010_0731)
10047939 (MedDRA 13.1)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Creatinine
Item
Creatinine
string
C0201976 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
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)
Bilirubin
Item
Bilirubin
string
C1278039 (UMLS CUI)
79706000 (SNOMED CT 2010_0731)
1975-2 (LOINC Version 232)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Metastasis
Item
Metastasis
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Autoimmune Disorder
Item
Autoimmune Disease
string
C0004364 (UMLS CUI)
85828009 (SNOMED CT 2010_0731)
10061664 (MedDRA 13.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE Version 4.03)
Psychotic Disorders
Item
Psychosis (Psychotic disorder)
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)
Hepatitis
Item
Hepatitis
string
C0019158 (UMLS CUI)
29001004 (SNOMED CT 2010_0731)
10019717 (MedDRA 13.1)
Sepsis
Item
Systemic infection
string
C0243026 (UMLS CUI)
91302008 (SNOMED CT 2010_0731)
10040047 (MedDRA 13.1)
995.91 (ICD-9-CM Version 2011)
Myocardial Infarction (MI)
Item
Heart infarction
string
C0027051 (UMLS CUI)
22298006 (SNOMED CT 2010_0731)
10028596 (MedDRA 13.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE Version 4.03)
Chronic congestive heart failure
Item
Chronic congestive heart failure
string
C0264722 (UMLS CUI)
42343007 (SNOMED CT 2010_0731)
10007559 (MedDRA 13.1)
MTHU020787 (LOINC Version 232)
I50 (ICD-10-CM Version 2010)
428 (ICD-9-CM Version 2011)
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)
AIDS
Item
Acquired Immunodeficiency Syndrome
string
C0001175 (UMLS CUI)
62479008 (SNOMED CT 2010_0731)
10000565 (MedDRA 13.1)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
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)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
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