ID

19454

Description

2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT00191971

Link

https://clinicaltrials.gov/show/NCT00191971

Keywords

Versions (1)
  1. 1/3/17 1/3/17 -
Uploaded on

January 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Urologic Neoplasms NCT00191971

English

Eligibility Urologic Neoplasms NCT00191971

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically and/or cytologically confirmed tcc
Description

Carcinoma, Transitional Cell

Data type

boolean

Alias
UMLS CUI [1]
C0007138
received 1st line chemotherapy for locally advanced or metastatic tcc with cddp regimen
Description

chemotherapeutics regimen first line Transitional Cell Carcinoma Advanced Locally | chemotherapeutics regimen first line Transitional cell carcinoma metastatic | Cisplatin

Data type

boolean

Alias
UMLS CUI [1,1]
C2045825
UMLS CUI [1,2]
C0007138
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C1517927
UMLS CUI [2,1]
C2045825
UMLS CUI [2,2]
C3160869
UMLS CUI [3]
C0008838
to have at least one measurable region
Description

Measurable Disease region Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C1265611
ps: 0-2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
to have adequate organ function (bone marrow, liver and renal function)
Description

organ function | Bone Marrow function | Liver function | Normal renal function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0232805
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
to have interstitial pneumonia or pulmonary fibrosis
Description

Pneumonia, Interstitial | Pulmonary Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
within 4 weeks after the latest chemotherapy or radiotherapy
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
to have brain metastasis with symptom
Description

Metastatic malignant neoplasm to brain Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1457887
to have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
Description

Severe complication | Myocardial Infarction | Communicable Disease | Drug Allergy | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C3495031
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0013182
UMLS CUI [5]
C0011849
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Similar models

Eligibility Urologic Neoplasms NCT00191971

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma, Transitional Cell
Item
histologically and/or cytologically confirmed tcc
boolean
C0007138 (UMLS CUI [1])
chemotherapeutics regimen first line Transitional Cell Carcinoma Advanced Locally | chemotherapeutics regimen first line Transitional cell carcinoma metastatic | Cisplatin
Item
received 1st line chemotherapy for locally advanced or metastatic tcc with cddp regimen
boolean
C2045825 (UMLS CUI [1,1])
C0007138 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1517927 (UMLS CUI [1,4])
C2045825 (UMLS CUI [2,1])
C3160869 (UMLS CUI [2,2])
C0008838 (UMLS CUI [3])
Measurable Disease region Quantity
Item
to have at least one measurable region
boolean
C1513041 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
performance status
Item
ps: 0-2
boolean
C1518965 (UMLS CUI [1])
organ function | Bone Marrow function | Liver function | Normal renal function
Item
to have adequate organ function (bone marrow, liver and renal function)
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3])
C0232805 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pneumonia, Interstitial | Pulmonary Fibrosis
Item
to have interstitial pneumonia or pulmonary fibrosis
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
within 4 weeks after the latest chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Symptoms
Item
to have brain metastasis with symptom
boolean
C0220650 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Severe complication | Myocardial Infarction | Communicable Disease | Drug Allergy | Diabetes Mellitus
Item
to have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
boolean
C3495031 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0013182 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
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