ID

30155

Description

Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00824265

Link

https://clinicaltrials.gov/show/NCT00824265

Keywords

Versions (1)
  1. 5/16/18 5/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 16, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Leukaemia, Lymphocytic, Chronic NCT00824265

English

Eligibility Leukaemia, Lymphocytic, Chronic NCT00824265

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed and active cll requiring treatment
Description

Chronic Lymphocytic Leukemia Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332121
at least one previous treatment for cll and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
Description

Prior Therapy Quantity Chronic Lymphocytic Leukemia | Complete remission | Partial response | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
UMLS CUI [2]
C0677874
UMLS CUI [3]
C1521726
UMLS CUI [4]
C0242656
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
Description

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

Data type

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
Description

Age

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of refractory cll (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-cll treatment
Description

Chronic lymphocytic leukaemia refractory | Complete remission failed | Partial response failed | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0278791
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0231175
UMLS CUI [4]
C0242656
abnormal/inadequate blood values, liver and kidney function
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0262364
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0151746
certain heart problems, serious significant diseases, aiha, other current cancers or within the last 5 years
Description

Heart problems | Disease Serious | Autoimmune hemolytic anemia | Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C0795691
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0002880
UMLS CUI [4]
C1707251
active or chronic infections
Description

Communicable Diseases | Chronic infectious disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
Description

Anti-Allergic Agents | Anti-Inflammatory Agents | Glucocorticoids

Data type

boolean

Alias
UMLS CUI [1]
C0282555
UMLS CUI [2]
C0003209
UMLS CUI [3]
C0017710
cll transformation
Description

Chronic lymphocytic leukaemia transformation

Data type

boolean

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

Chronic Lymphocytic Leukemia | Central Nervous System Involvement

Data type

boolean

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

Study Subject Participation Status

Data type

boolean

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

Protocol Compliance Unable

Data type

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
Description

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

Data type

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
Back to the top of the page

Similar models

Eligibility Leukaemia, Lymphocytic, Chronic NCT00824265

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Treatment required for
Item
confirmed and active cll requiring treatment
boolean
C0023434 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Prior Therapy Quantity Chronic Lymphocytic Leukemia | Complete remission | Partial response | Disease Progression
Item
at least one previous treatment for cll and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2])
C1521726 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
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)
Chronic lymphocytic leukaemia refractory | Complete remission failed | Partial response failed | Disease Progression
Item
diagnosis of refractory cll (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-cll treatment
boolean
C0278791 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
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 | Disease Serious | Autoimmune hemolytic anemia | Cancer Other
Item
certain heart problems, serious significant diseases, aiha, other current cancers or within the last 5 years
boolean
C0795691 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0002880 (UMLS CUI [3])
C1707251 (UMLS CUI [4])
Communicable Diseases | Chronic infectious disease
Item
active or chronic infections
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Anti-Allergic Agents | Anti-Inflammatory Agents | Glucocorticoids
Item
use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
boolean
C0282555 (UMLS CUI [1])
C0003209 (UMLS CUI [2])
C0017710 (UMLS CUI [3])
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial