ID

35315

Description

A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01739491

Link

https://clinicaltrials.gov/show/NCT01739491

Keywords

Versions (1)
  1. 2/27/19 2/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT01739491

English

Eligibility Chronic Lymphocytic Leukemia NCT01739491

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult filipino patients with chronic lymphocytic leukemia
Description

Adult | Filipino | Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C1556093
UMLS CUI [3]
C0023434
patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic binet stage b or c) and for whom fludarabine combination chemotherapy is not appropriate
Description

Chronic Lymphocytic Leukemia Symptomatic Binet Staging System | Patients Inappropriate Fludarabine Combination Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1511118
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0059985
UMLS CUI [2,4]
C1521750
world health organization performance status of 0, 1, or 2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
need-to-treat criteria in b-cell chronic lymphocytic leukemia
Description

Chronic Lymphocytic Leukemia Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
had received previous treatment with other cytotoxic drugs
Description

Cytotoxic agent

Data type

boolean

Alias
UMLS CUI [1]
C0304497
had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer)
Description

Second malignancy | Exception Basal cell carcinoma Cured | Exception Cervical cancer Cured

Data type

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C4048328
UMLS CUI [3,3]
C1880198
concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection
Description

Comorbidity | Heart failure | Cardiomyopathy | Myocardial Infarction | Diabetes mellitus uncontrolled Severe | Uncontrolled hypertension Severe | Communicable Disease Requirement Antibiotic therapy Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0878544
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0421258
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C1868885
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0338237
UMLS CUI [7,4]
C0205373
patients with severe renal and hepatic impairment
Description

Renal Insufficiency Severe | Hepatic impairment Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205082
patients with severe bone marrow suppression and severe blood count alterations
Description

Bone Marrow Suppression Severe | Blood Count Alteration Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0280962
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0005771
UMLS CUI [2,2]
C1515926
UMLS CUI [2,3]
C0205082
pregnant women and lactating mothers
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Chronic Lymphocytic Leukemia NCT01739491

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Filipino | Chronic Lymphocytic Leukemia
Item
adult filipino patients with chronic lymphocytic leukemia
boolean
C0001675 (UMLS CUI [1])
C1556093 (UMLS CUI [2])
C0023434 (UMLS CUI [3])
Chronic Lymphocytic Leukemia Symptomatic Binet Staging System | Patients Inappropriate Fludarabine Combination Chemotherapy
Item
patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic binet stage b or c) and for whom fludarabine combination chemotherapy is not appropriate
boolean
C0023434 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1511118 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0059985 (UMLS CUI [2,3])
C1521750 (UMLS CUI [2,4])
WHO performance status scale
Item
world health organization performance status of 0, 1, or 2
boolean
C1298650 (UMLS CUI [1])
Chronic Lymphocytic Leukemia Criteria Fulfill
Item
need-to-treat criteria in b-cell chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cytotoxic agent
Item
had received previous treatment with other cytotoxic drugs
boolean
C0304497 (UMLS CUI [1])
Second malignancy | Exception Basal cell carcinoma Cured | Exception Cervical cancer Cured
Item
had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer)
boolean
C0085183 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C4048328 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
Comorbidity | Heart failure | Cardiomyopathy | Myocardial Infarction | Diabetes mellitus uncontrolled Severe | Uncontrolled hypertension Severe | Communicable Disease Requirement Antibiotic therapy Systemic
Item
concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection
boolean
C0009488 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0878544 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0421258 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0338237 (UMLS CUI [7,3])
C0205373 (UMLS CUI [7,4])
Renal Insufficiency Severe | Hepatic impairment Severe
Item
patients with severe renal and hepatic impairment
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Bone Marrow Suppression Severe | Blood Count Alteration Severe
Item
patients with severe bone marrow suppression and severe blood count alterations
boolean
C0280962 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0005771 (UMLS CUI [2,1])
C1515926 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant women and lactating mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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