ID

14451

Description

A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia; ODM derived from: https://clinicaltrials.gov/show/NCT00220311

Link

https://clinicaltrials.gov/show/NCT00220311

Keywords

Versions (1)
  1. 4/15/16 4/15/16 -
Uploaded on

April 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00220311

English

Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00220311

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically or cytologically confirmed cll
Description

CLL

Data type

boolean

Alias
UMLS CUI [1]
C0023434
patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal
Description

Hemoglobin and platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
patients who have not received cancer chemotherapy or radiotherapy
Description

No chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332155
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with apparent infections (including viral infections)
Description

Infections

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patients with serious complications (heart, liver, or kidney disease, etc.)
Description

Complications

Data type

boolean

Alias
UMLS CUI [1]
C0009566
patients with a serious bleeding tendency (e.g., dic)
Description

Bleeding tendency

Data type

boolean

Alias
UMLS CUI [1]
C0005779
patients with serious cns symptoms
Description

CNS symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0422879
patients with fever >= 38°c (excluding tumor fever)
Description

Fever (excluding tumor fever)

Data type

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2,1]
C0332196
UMLS CUI [2,2]
C0948348
patients with interstitial pneumonia or pulmonary fibrosis
Description

Interstitial pneumonia or pulmonary fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
patients with active multiple cancers
Description

Multiple cancers

Data type

boolean

Alias
UMLS CUI [1]
C0346429
patients receiving other investigational products within 6 months before registration in this study
Description

Experimental drug

Data type

boolean

Alias
UMLS CUI [1]
C0304229
patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives)
Description

Allergy to trial product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
women who are pregnant, of childbearing potential, or lactating
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
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Similar models

Eligibility Leukemia, Lymphocytic, Chronic, B-Cell NCT00220311

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
CLL
Item
patients with histologically or cytologically confirmed cll
boolean
C0023434 (UMLS CUI [1])
Hemoglobin and platelet count
Item
patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
No chemotherapy or radiotherapy
Item
patients who have not received cancer chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Infections
Item
patients with apparent infections (including viral infections)
boolean
C0009450 (UMLS CUI [1])
Complications
Item
patients with serious complications (heart, liver, or kidney disease, etc.)
boolean
C0009566 (UMLS CUI [1])
Bleeding tendency
Item
patients with a serious bleeding tendency (e.g., dic)
boolean
C0005779 (UMLS CUI [1])
CNS symptoms
Item
patients with serious cns symptoms
boolean
C0422879 (UMLS CUI [1])
Fever (excluding tumor fever)
Item
patients with fever >= 38°c (excluding tumor fever)
boolean
C0015967 (UMLS CUI [1])
C0332196 (UMLS CUI [2,1])
C0948348 (UMLS CUI [2,2])
Interstitial pneumonia or pulmonary fibrosis
Item
patients with interstitial pneumonia or pulmonary fibrosis
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
Multiple cancers
Item
patients with active multiple cancers
boolean
C0346429 (UMLS CUI [1])
Experimental drug
Item
patients receiving other investigational products within 6 months before registration in this study
boolean
C0304229 (UMLS CUI [1])
Allergy to trial product
Item
patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives)
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Gynaecological status
Item
women who are pregnant, of childbearing potential, or lactating
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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