ID

21066

Descripción

An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01902862

Link

https://clinicaltrials.gov/show/NCT01902862

Palabras clave

Versiones (1)
  1. 7/4/17 7/4/17 -
Subido en

7 de abril de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

Sin comentarios

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Lymphoma, Follicular NCT01902862

Inglés

Eligibility Lymphoma, Follicular NCT01902862

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
Descripción

Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C0277556
UMLS CUI [1,4]
C1514815
UMLS CUI [2]
C1272836
UMLS CUI [3]
C0882818
participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
Descripción

rituximab planned, prior chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C1514457
women must be either postmenopausal or sterilized; negative pregnancy test at screening
Descripción

postmenopausal state, sterilized, pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0032961
participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
Descripción

total bilirubin, creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0201976
participants with karnofsky status greater than or equal to 60 percent
Descripción

karnofsky

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
Descripción

Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1541445
participants with previous known allergic reaction to bortezomib, boron or mannitol
Descripción

previous known allergic reaction to bortezomib, boron or mannitol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0024730
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0006030
participants with life-expectancy of less than 3 months
Descripción

life-expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
Descripción

history of cancer, basalioma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0007117
participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
Descripción

peripheral neuropathy, common terminology criteria for adverse events (ctcae)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C3888020
Volver a la parte superior de la página

Similar models

Eligibility Lymphoma, Follicular NCT01902862

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen
Item
participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
boolean
C0024301 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1514815 (UMLS CUI [1,4])
C1272836 (UMLS CUI [2])
C0882818 (UMLS CUI [3])
rituximab planned, prior chemotherapy
Item
participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
boolean
C0393022 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
postmenopausal state, sterilized, pregnancy
Item
women must be either postmenopausal or sterilized; negative pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
total bilirubin, creatinine
Item
participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
boolean
C0201913 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
karnofsky
Item
participants with karnofsky status greater than or equal to 60 percent
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab
Item
participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
boolean
C1514463 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1541445 (UMLS CUI [2,2])
previous known allergic reaction to bortezomib, boron or mannitol
Item
participants with previous known allergic reaction to bortezomib, boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0006030 (UMLS CUI [3,2])
life-expectancy
Item
participants with life-expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
history of cancer, basalioma
Item
participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
peripheral neuropathy, common terminology criteria for adverse events (ctcae)
Item
participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
boolean
C0031117 (UMLS CUI [1,1])
C3888020 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Ayuda

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