ID

30154

Descripción

Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00748189

Link

https://clinicaltrials.gov/show/NCT00748189

Palabras clave

Versiones (2)
  1. 15/5/18 15/5/18 -
  2. 16/5/18 16/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukaemia, Lymphocytic, Chronic NCT00748189

Inglés

Eligibility Leukaemia, Lymphocytic, Chronic NCT00748189

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed cll diagnosis and active cll requiring treatment
Descripción

Chronic Lymphocytic Leukemia Treatment required for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332121
considered inappropriate for fludarabine-based therapy
Descripción

Patient Inappropriate Fludarabine therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0059985
UMLS CUI [1,4]
C0087111
not been treated for cll before
Descripción

Chronic Lymphocytic Leukemia untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332155
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
Descripción

Other Coding | Self-care Capability | Fit and well Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0036592
UMLS CUI [2,2]
C2698977
UMLS CUI [3,1]
C0424576
UMLS CUI [3,2]
C0439165
age 18yrs or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
signed written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior cll therapy
Descripción

Prior Therapy Chronic Lymphocytic Leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023434
abnormal/inadequate blood values, liver, and kidney function
Descripción

ABNORMAL LABORATORY RESULT (HEMATOLOGY) | Liver Dysfunction | Abnormal renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262364
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0151746
certain heart problems, active or chronic infections, serious significant diseases, aiha requiring treatment, other current cancer or within last 5 years
Descripción

Heart problems | Communicable Diseases | Chronic infectious disease | Disease Serious | Autoimmune hemolytic anemia Treatment required for | Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0795691
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0151317
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205404
UMLS CUI [5,1]
C0002880
UMLS CUI [5,2]
C0332121
UMLS CUI [6]
C1707251
cll transformation
Descripción

Chronic lymphocytic leukaemia transformation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1142081
cll central nervous system involvement
Descripción

Chronic Lymphocytic Leukemia | Central Nervous System Involvement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C4050309
current participation in other clinical study
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
inability to comply with the protocol activities
Descripción

Protocol Compliance Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Descripción

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Gender Partner in relationship Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C3831118
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Similar models

Eligibility Leukaemia, Lymphocytic, Chronic NCT00748189

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Treatment required for
Item
confirmed cll diagnosis and active cll requiring treatment
boolean
C0023434 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Patient Inappropriate Fludarabine therapy
Item
considered inappropriate for fludarabine-based therapy
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0059985 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Chronic Lymphocytic Leukemia untreated
Item
not been treated for cll before
boolean
C0023434 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Other Coding | Self-care Capability | Fit and well Percentage
Item
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
boolean
C3846158 (UMLS CUI [1])
C0036592 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C0424576 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Age
Item
age 18yrs or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Chronic Lymphocytic Leukemia
Item
prior cll therapy
boolean
C1514463 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
ABNORMAL LABORATORY RESULT (HEMATOLOGY) | Liver Dysfunction | Abnormal renal function
Item
abnormal/inadequate blood values, liver, and kidney function
boolean
C0262364 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0151746 (UMLS CUI [3])
Heart problems | Communicable Diseases | Chronic infectious disease | Disease Serious | Autoimmune hemolytic anemia Treatment required for | Cancer Other
Item
certain heart problems, active or chronic infections, serious significant diseases, aiha requiring treatment, other current cancer or within last 5 years
boolean
C0795691 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0002880 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
C1707251 (UMLS CUI [6])
Chronic lymphocytic leukaemia transformation
Item
cll transformation
boolean
C1142081 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Central Nervous System Involvement
Item
cll central nervous system involvement
boolean
C0023434 (UMLS CUI [1])
C4050309 (UMLS CUI [2])
Study Subject Participation Status
Item
current participation in other clinical study
boolean
C2348568 (UMLS CUI [1])
Protocol Compliance Unable
Item
inability to comply with the protocol activities
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Gender Partner in relationship Childbearing Potential
Item
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C3831118 (UMLS CUI [4,3])
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