ID

38231

Descripción

A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours; ODM derived from: https://clinicaltrials.gov/show/NCT01493336

Link

https://clinicaltrials.gov/show/NCT01493336

Palabras clave

Versiones (1)
  1. 30/9/19 30/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

30 de septiembre de 2019

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 :

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

Eligibility Breast Cancer, Colorectal Cancer NCT01493336

Inglés

Eligibility Breast Cancer, Colorectal Cancer NCT01493336

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
histological/cytological confirmation of colorectal or breast cancer
Descripción

Colorectal Carcinoma | Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C0678222
patient is ambulatory and has a karnofsky performance status of > 70%
Descripción

Patient Ambulatory | Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439841
UMLS CUI [2]
C0206065
body surface area between 1.5 and 2.0 m2
Descripción

Body Surface Area

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005902
either:
Descripción

Either

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3844638
due to receive xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
Descripción

Etiology | Xeloda | Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0724419
UMLS CUI [3]
C0009429
currently receiving xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on day 1 and day 2
Descripción

Xeloda | Ability Receive Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0724419
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0013230
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to xeloda
Descripción

Medical contraindication Xeloda

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0724419
received xeloda in the 6 days prior to day 1
Descripción

Xeloda Received Recently

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0724419
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0332185
subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
Descripción

Organ allografts | Exception Autologous bone marrow transplant Post High-dose chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0194037
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C1328050
renal impairment
Descripción

Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
pregnant or lactating females
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in an investigational drug study within 28 days prior to screening
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
Descripción

Lacking Integrity Upper Gastrointestinal Tract | Malabsorption Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C1947912
UMLS CUI [1,3]
C3203348
UMLS CUI [2]
C0024523
serious uncontrolled intercurrent infections
Descripción

Communicable Diseases Serious Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
history of clinically significant coronary artery disease
Descripción

Coronary Artery Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1956346
concomitant treatment with warfarin
Descripción

Warfarin therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4303340
known dihydropyrimidine dehydrogenase deficiency
Descripción

Dihydropyrimidine Dehydrogenase Deficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1959620
Volver a la parte superior de la página

Similar models

Eligibility Breast Cancer, Colorectal Cancer NCT01493336

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])
Colorectal Carcinoma | Breast Carcinoma
Item
histological/cytological confirmation of colorectal or breast cancer
boolean
C0009402 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Patient Ambulatory | Karnofsky Performance Status
Item
patient is ambulatory and has a karnofsky performance status of > 70%
boolean
C0030705 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0206065 (UMLS CUI [2])
Body Surface Area
Item
body surface area between 1.5 and 2.0 m2
boolean
C0005902 (UMLS CUI [1])
Either
Item
either:
boolean
C3844638 (UMLS CUI [1])
Etiology | Xeloda | Combined Modality Therapy
Item
due to receive xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
boolean
C0015127 (UMLS CUI [1])
C0724419 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Xeloda | Ability Receive Investigational New Drugs
Item
currently receiving xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on day 1 and day 2
boolean
C0724419 (UMLS CUI [1])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Xeloda
Item
any contraindication to xeloda
boolean
C1301624 (UMLS CUI [1,1])
C0724419 (UMLS CUI [1,2])
Xeloda Received Recently
Item
received xeloda in the 6 days prior to day 1
boolean
C0724419 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Organ allografts | Exception Autologous bone marrow transplant Post High-dose chemotherapy
Item
subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0194037 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C1328050 (UMLS CUI [2,4])
Renal Insufficiency
Item
renal impairment
boolean
C1565489 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in an investigational drug study within 28 days prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Lacking Integrity Upper Gastrointestinal Tract | Malabsorption Syndrome
Item
lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
boolean
C0332268 (UMLS CUI [1,1])
C1947912 (UMLS CUI [1,2])
C3203348 (UMLS CUI [1,3])
C0024523 (UMLS CUI [2])
Communicable Diseases Serious Uncontrolled
Item
serious uncontrolled intercurrent infections
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Coronary Artery Disease
Item
history of clinically significant coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Warfarin therapy
Item
concomitant treatment with warfarin
boolean
C4303340 (UMLS CUI [1])
Dihydropyrimidine Dehydrogenase Deficiency
Item
known dihydropyrimidine dehydrogenase deficiency
boolean
C1959620 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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