ID

41219

Descripción

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01144403

Link

https://clinicaltrials.gov/show/NCT01144403

Palabras clave

Versiones (1)
  1. 18/7/20 18/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de julio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT01144403

Inglés

Eligibility Lymphoma, B-Cell NCT01144403

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/=18 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
untreated mantle cell lymphoma, not eligible for autologous stem cell transplantation
Descripción

Mantle cell lymphoma Untreated | Ineligibility Autologous hematopoietic stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0334634
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C2193200
known mantle cell lymphoma international prognostic index (mipi) at diagnosis
Descripción

MIPI - Mantle Cell Lymphoma International Prognostic Index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4706335
ecog performance status 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, renal and hepatic function
Descripción

Hematologic function | Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to murine proteins or chemotherapy regimen
Descripción

Hypersensitivity Murine protein | Hypersensitivity Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0392920
previous first-line therapy
Descripción

First line treatment Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0205156
history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
Descripción

Cancer Other | Exception Squamous cell carcinoma | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007137
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
active infection
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
clinically significant cardiac disease
Descripción

Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Descripción

Steroid therapy Regular

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205272
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Similar models

Eligibility Lymphoma, B-Cell NCT01144403

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Mantle cell lymphoma Untreated | Ineligibility Autologous hematopoietic stem cell transplant
Item
untreated mantle cell lymphoma, not eligible for autologous stem cell transplantation
boolean
C0334634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C2193200 (UMLS CUI [2,2])
MIPI - Mantle Cell Lymphoma International Prognostic Index
Item
known mantle cell lymphoma international prognostic index (mipi) at diagnosis
boolean
C4706335 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematological, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Murine protein | Hypersensitivity Chemotherapy
Item
known hypersensitivity to murine proteins or chemotherapy regimen
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
First line treatment Previous
Item
previous first-line therapy
boolean
C1708063 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Cancer Other | Exception Squamous cell carcinoma | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007137 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Steroid therapy Regular
Item
regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
boolean
C0149783 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Volver a la parte superior de la página 

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