ID

18138

Beschreibung

A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00057564

Link

https://clinicaltrials.gov/show/NCT00057564

Stichworte

Versionen (1)
  1. 22.10.16 22.10.16 -
Hochgeladen am

22. Oktober 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Multiple Myeloma NCT00057564

Englisch

Eligibility Multiple Myeloma NCT00057564

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
active multiple myeloma stage ii or iii durie salmon
Beschreibung

Multiple Myeloma | Staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0332305
measurable levels of myeloma paraprotein in serum (≥1.0g/dl) or urine (≥ 0.2g excreted in a 24-hour collection sample)
Beschreibung

Multiple Myeloma Serum paraprotein level result | Multiple Myeloma Urine paraprotein level result | Specimen Collection 24 Hours

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1318383
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C1318384
UMLS CUI [3,1]
C0200345
UMLS CUI [3,2]
C1442770
eastern cooperative oncology group (ecog) performance status of 0, 1, 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
Beschreibung

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity | Hormonal contraception | Tubal Ligation | Contraception, Barrier | Latex condom | Vaginal contraceptive diaphragm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0520483
UMLS CUI [5]
C0004764
UMLS CUI [6]
C3873750
UMLS CUI [7]
C0042241
males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity
Beschreibung

Gender Sex Behavior Contraception, Barrier | Gender Sex Behavior Latex condom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036864
UMLS CUI [1,3]
C0004764
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036864
UMLS CUI [2,3]
C3873750
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
peripheral neuropathy ≥ to grade 2 of the nci ctc.
Beschreibung

Peripheral Neuropathy | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
prior history of malignancy unless subject has been free of disease for ≥ 3 years
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
lab abnormality: absolute neutrophil count (anc) <1,000 cells/mm^3 (1.0 x 10^9/l)
Beschreibung

LABORATORY ABNORMALITIES | Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0948762
lab abnormality: platelet count <50,000/mm^3 (50.0 x 10^9/l)
Beschreibung

LABORATORY ABNORMALITIES | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0032181
lab abnormality: serum creatinine >3.0 mg/dl (265 µmol/l)
Beschreibung

LABORATORY ABNORMALITIES | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0201976
lab abnormality: serum glutamic oxaloacetic transaminase (sgot) /aspartate aminotransferase (ast) or serum glutamic pyruvic transaminase (sgpt)/alanine transaminase (alt) >3.0 x upper limit of normal (uln)
Beschreibung

LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
lab abnormality: serum total bilirubin > 2.0 mg/dl (34 µmol/l)
Beschreibung

LABORATORY ABNORMALITIES | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C1278039
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Multiple Myeloma NCT00057564

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Staging
Item
active multiple myeloma stage ii or iii durie salmon
boolean
C0026764 (UMLS CUI [1])
C0332305 (UMLS CUI [2])
Multiple Myeloma Serum paraprotein level result | Multiple Myeloma Urine paraprotein level result | Specimen Collection 24 Hours
Item
measurable levels of myeloma paraprotein in serum (≥1.0g/dl) or urine (≥ 0.2g excreted in a 24-hour collection sample)
boolean
C0026764 (UMLS CUI [1,1])
C1318383 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C1318384 (UMLS CUI [2,2])
C0200345 (UMLS CUI [3,1])
C1442770 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, 2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity | Hormonal contraception | Tubal Ligation | Contraception, Barrier | Latex condom | Vaginal contraceptive diaphragm
Item
women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2985296 (UMLS CUI [3])
C0520483 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C3873750 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
Gender Sex Behavior Contraception, Barrier | Gender Sex Behavior Latex condom
Item
males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity
boolean
C0079399 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0036864 (UMLS CUI [2,2])
C3873750 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy ≥ to grade 2 of the nci ctc.
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Malignant Neoplasms
Item
prior history of malignancy unless subject has been free of disease for ≥ 3 years
boolean
C0006826 (UMLS CUI [1])
LABORATORY ABNORMALITIES | Absolute neutrophil count
Item
lab abnormality: absolute neutrophil count (anc) <1,000 cells/mm^3 (1.0 x 10^9/l)
boolean
C1853129 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Platelet Count measurement
Item
lab abnormality: platelet count <50,000/mm^3 (50.0 x 10^9/l)
boolean
C1853129 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Creatinine measurement, serum
Item
lab abnormality: serum creatinine >3.0 mg/dl (265 µmol/l)
boolean
C1853129 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
lab abnormality: serum glutamic oxaloacetic transaminase (sgot) /aspartate aminotransferase (ast) or serum glutamic pyruvic transaminase (sgpt)/alanine transaminase (alt) >3.0 x upper limit of normal (uln)
boolean
C1853129 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
LABORATORY ABNORMALITIES | Serum total bilirubin measurement
Item
lab abnormality: serum total bilirubin > 2.0 mg/dl (34 µmol/l)
boolean
C1853129 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video