ID

79

Descripción

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00661609

Link

http://clinicaltrials.gov/ct2/show/record/NCT00661609

Palabras clave

  1. 18/11/11 18/11/11 -
  2. 26/3/14 26/3/14 - Martin Dugas
  3. 17/9/21 17/9/21 -
Subido en

18 de noviembre de 2011

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00661609 Bladder Cancer

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Descripción

Inclusion criteria

Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra)
Descripción

Urothelial cancer

Tipo de datos

boolean

Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
Descripción

Stage IV

Tipo de datos

boolean

Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting
Descripción

Prior chemotherapy

Tipo de datos

boolean

Ambulatory and capable of all selfcare more than 50% of waking hours
Descripción

General status

Tipo de datos

boolean

Exclusion criteria
Descripción

Exclusion criteria

Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication, 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
Descripción

Prior treatment

Tipo de datos

boolean

Inadequate bone marrow reserve
Descripción

Bone marrow

Tipo de datos

boolean

Inadequate liver function in the presence of liver metastases
Descripción

Liver

Tipo de datos

boolean

Impaired renal function
Descripción

Kidney

Tipo de datos

boolean

Medical concepts
Descripción

Medical concepts

Diagnosis
Descripción

Diagnosis

Tipo de datos

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Carcinoma of bladder
Descripción

Bladder Cancer

Tipo de datos

string

Alias
UMLS CUI
C0699885
SNOMED CT 2010_0731
255108000
MedDRA 13.1
10005014
Diagnostic Neoplasm Staging
Descripción

Tumor Staging

Tipo de datos

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Chemotherapy
Descripción

Chemotherapy

Tipo de datos

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Ambulatory
Descripción

Ambulatory

Tipo de datos

string

Alias
UMLS CUI
C0439841
Radiotherapy
Descripción

Radiotherapy

Tipo de datos

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
White Blood Cells
Descripción

WBC

Tipo de datos

string

Alias
SNOMED CT 2010_0731
767002
LOINC Version 232
6690-2
Platelet count - finding
Descripción

Platelet count

Tipo de datos

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Hemoglobin
Descripción

Hemoglobin

Tipo de datos

string

Alias
UMLS CUI
C0019046
SNOMED CT 2010_0731
38082009
MedDRA 13.1
10019481
LOINC Version 232
LP14449-0
Metastatic Malignant Neoplasm to the Liver
Descripción

Liver Metastasis

Tipo de datos

string

Alias
UMLS CUI
C0494165
SNOMED CT 2010_0731
94381002
MedDRA 13.1
10027457
ICD-10-CM Version 2010
C78.7
ICD-9-CM Version 2011
197.7

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion criteria
Urothelial cancer
Item
Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra)
boolean
Stage IV
Item
Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
boolean
Prior chemotherapy
Item
Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting
boolean
General status
Item
Ambulatory and capable of all selfcare more than 50% of waking hours
boolean
Item Group
Exclusion criteria
Prior treatment
Item
Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication, 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
boolean
Bone marrow
Item
Inadequate bone marrow reserve
boolean
Liver
Item
Inadequate liver function in the presence of liver metastases
boolean
Kidney
Item
Impaired renal function
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Bladder Cancer
Item
Carcinoma of bladder
string
C0699885 (UMLS CUI)
255108000 (SNOMED CT 2010_0731)
10005014 (MedDRA 13.1)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Ambulatory
Item
Ambulatory
string
C0439841 (UMLS CUI)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
WBC
Item
White Blood Cells
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC Version 232)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Hemoglobin
Item
Hemoglobin
string
C0019046 (UMLS CUI)
38082009 (SNOMED CT 2010_0731)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC Version 232)
Liver Metastasis
Item
Metastatic Malignant Neoplasm to the Liver
string
C0494165 (UMLS CUI)
94381002 (SNOMED CT 2010_0731)
10027457 (MedDRA 13.1)
C78.7 (ICD-10-CM Version 2010)
197.7 (ICD-9-CM Version 2011)

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