ID

18137

Beschrijving

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00056160

Link

https://clinicaltrials.gov/show/NCT00056160

Trefwoorden

Versies (1)
  1. 22-10-16 22-10-16 -
Geüploaded op

22 oktober 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Multiple Myeloma NCT00056160

Engels

Eligibility Multiple Myeloma NCT00056160

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
prior or current diagnosis durie-salmon stage ii or iii multiple myeloma.
Beschrijving

Multiple Myeloma | Staging

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0332305
no more than 3 previous anti-myeloma regimens
Beschrijving

Regimen Quantity Against Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0521124
UMLS CUI [1,4]
C0026764
no high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
Beschrijving

Dexamethasone High dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0444956
measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
Beschrijving

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

Datatype

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
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior development of disease progression during high-dose dexamethasone containing therapy.
Beschrijving

Dexamethasone High dose | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C0242656
laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm cubed
Beschrijving

LABORATORY ABNORMALITIES | Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0948762
laboratory abnormalities: platelet count less than 75,000/mm cubed
Beschrijving

LABORATORY ABNORMALITIES | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0032181
laboratory abnormalities: serum creatinine greater than 2.5 mg/dl
Beschrijving

LABORATORY ABNORMALITIES | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0201976
laboratory abnormalities: serum glutamic oxaloacetic transaminase (sgot, aspartate transaminase [ast]) or serum glutamic pyruvic transaminase (sgpt, alanine transaminase [alt])greater than 3.0 x upper limit of normal
Beschrijving

LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
laboratory abnormalities: serum total bilirubin greater than 2.0 mg/dl
Beschrijving

LABORATORY ABNORMALITIES | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C1278039
prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
Beschrijving

Malignant Neoplasms | Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0026764
known hypersensitivity to thalidomide or dexamethasone.
Beschrijving

Hypersensitivity Thalidomide | Dexamethasone allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2]
C0571611
development of a desquamating rash while taking thalidomide.
Beschrijving

Thalidomide | Rash desquamating

Datatype

boolean

Alias
UMLS CUI [1]
C0039736
UMLS CUI [2]
C0542171
Terug naar het begin van de pagina

Similar models

Eligibility Multiple Myeloma NCT00056160

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Staging
Item
prior or current diagnosis durie-salmon stage ii or iii multiple myeloma.
boolean
C0026764 (UMLS CUI [1])
C0332305 (UMLS CUI [2])
Regimen Quantity Against Multiple Myeloma
Item
no more than 3 previous anti-myeloma regimens
boolean
C0040808 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C0026764 (UMLS CUI [1,4])
Dexamethasone High dose
Item
no high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
boolean
C0011777 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Multiple Myeloma Serum paraprotein level result | Multiple Myeloma Urine paraprotein level result | Specimen Collection 24 Hours
Item
measurable levels of myeloma paraprotein in serum or urine (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])
Item Group
C0680251 (UMLS CUI)
Dexamethasone High dose | Disease Progression
Item
prior development of disease progression during high-dose dexamethasone containing therapy.
boolean
C0011777 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Absolute neutrophil count
Item
laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm cubed
boolean
C1853129 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Platelet Count measurement
Item
laboratory abnormalities: platelet count less than 75,000/mm cubed
boolean
C1853129 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Creatinine measurement, serum
Item
laboratory abnormalities: serum creatinine greater than 2.5 mg/dl
boolean
C1853129 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
laboratory abnormalities: serum glutamic oxaloacetic transaminase (sgot, aspartate transaminase [ast]) or serum glutamic pyruvic transaminase (sgpt, alanine transaminase [alt])greater than 3.0 x upper limit of normal
boolean
C1853129 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
LABORATORY ABNORMALITIES | Serum total bilirubin measurement
Item
laboratory abnormalities: serum total bilirubin greater than 2.0 mg/dl
boolean
C1853129 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Malignant Neoplasms | Multiple Myeloma
Item
prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
boolean
C0006826 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
Hypersensitivity Thalidomide | Dexamethasone allergy
Item
known hypersensitivity to thalidomide or dexamethasone.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0571611 (UMLS CUI [2])
Thalidomide | Rash desquamating
Item
development of a desquamating rash while taking thalidomide.
boolean
C0039736 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial