ID

26001

Description

Safety and Dose Ranging Study of ALXN6000 to Treat Relapsing or Refractory CLL or MM; ODM derived from: https://clinicaltrials.gov/show/NCT00648739

Link

https://clinicaltrials.gov/show/NCT00648739

Keywords

Versions (1)
  1. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

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 B-cell Chronic Lymphocytic Leukemia NCT00648739

English

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing or refractory b cll or mm
Description

Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Recurrent multiple myeloma | Refractory multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0854802
UMLS CUI [2]
C0278791
UMLS CUI [3]
C1370446
UMLS CUI [4]
C0278620
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
anticipated survival of greater than 6 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
female patients of childbearing potential must agree to use two forms of contraception
Description

Childbearing Potential Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
patients must have a standard indication for treatment of their malignancy
Description

Standard Indication Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0920425
is willing and able to give written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
absolute neutrophil count (anc) < 1000 x 109/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 50,000 x 109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior history of autoimmune hemolysis requiring therapy.
Description

Hemolysis Autoimmune Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0019054
UMLS CUI [1,2]
C0443146
UMLS CUI [1,3]
C0332121
prior history of immune thrombocytopenia.
Description

Autoimmune thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0242584
active autoimmune disease requiring immunosuppressive therapy.
Description

Autoimmune Disease Requirement Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
positive coombs' test (neither direct or indirect)
Description

Direct Coombs test positive | Indirect Coombs test positive

Data type

boolean

Alias
UMLS CUI [1]
C0151569
UMLS CUI [2]
C0151570
ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
Description

Adrenal Cortex Hormones | Equivalent Mineralocorticoid Effect Prednisone U/day

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C3179191
UMLS CUI [2,3]
C0032952
UMLS CUI [2,4]
C0456683
prior stem cell transplantation within 4 weeks prior to enrollment.
Description

Stem cell transplantation

Data type

boolean

Alias
UMLS CUI [1]
C1504389
prior chemotherapy for the applicable malignancy within 30 days of enrollment.
Description

Chemotherapy Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
neurosurgery or cranial radiation therapy within one year of enrollment.
Description

Neurosurgical Procedures | Therapeutic radiology procedure cranial

Data type

boolean

Alias
UMLS CUI [1]
C0524850
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0037303
clinically significant renal, hepatic or heart disease.
Description

Kidney Disease | Liver disease | Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018799
Back to the top of the page

Similar models

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Recurrent multiple myeloma | Refractory multiple myeloma
Item
relapsing or refractory b cll or mm
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2])
C1370446 (UMLS CUI [3])
C0278620 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
anticipated survival of greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity
Item
female patients of childbearing potential must agree to use two forms of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Standard Indication Cancer treatment
Item
patients must have a standard indication for treatment of their malignancy
boolean
C1442989 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Informed Consent
Item
is willing and able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1000 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 50,000 x 109/l
boolean
C0032181 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hemolysis Autoimmune Treatment required for
Item
prior history of autoimmune hemolysis requiring therapy.
boolean
C0019054 (UMLS CUI [1,1])
C0443146 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Autoimmune thrombocytopenia
Item
prior history of immune thrombocytopenia.
boolean
C0242584 (UMLS CUI [1])
Autoimmune Disease Requirement Therapeutic immunosuppression
Item
active autoimmune disease requiring immunosuppressive therapy.
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Direct Coombs test positive | Indirect Coombs test positive
Item
positive coombs' test (neither direct or indirect)
boolean
C0151569 (UMLS CUI [1])
C0151570 (UMLS CUI [2])
Adrenal Cortex Hormones | Equivalent Mineralocorticoid Effect Prednisone U/day
Item
ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
boolean
C0001617 (UMLS CUI [1])
C0205163 (UMLS CUI [2,1])
C3179191 (UMLS CUI [2,2])
C0032952 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Stem cell transplantation
Item
prior stem cell transplantation within 4 weeks prior to enrollment.
boolean
C1504389 (UMLS CUI [1])
Chemotherapy Malignant Neoplasms
Item
prior chemotherapy for the applicable malignancy within 30 days of enrollment.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Neurosurgical Procedures | Therapeutic radiology procedure cranial
Item
neurosurgery or cranial radiation therapy within one year of enrollment.
boolean
C0524850 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0037303 (UMLS CUI [2,2])
Kidney Disease | Liver disease | Heart Disease
Item
clinically significant renal, hepatic or heart disease.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018799 (UMLS CUI [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