ID

17998

Description

Rituximab and Combination Chemotherapy Followed By Thalidomide in Treating Patients With Previously Untreated Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00450801

Link

https://clinicaltrials.gov/show/NCT00450801

Keywords

  1. 10/13/16 10/13/16 -
Uploaded on

October 13, 2016

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.

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 Lymphoma NCT00450801

Eligibility Lymphoma NCT00450801

  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00450801
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease characteristics:
Description

disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
histologically confirmed mantle cell lymphoma
Description

Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0334634
all stages allowed
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
previously untreated disease
Description

Disease untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
measurable or evaluable disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
no cns involvement
Description

Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1]
C4050309
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
bilirubin < 3 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
sgot and/or sgpt < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Lymphomatous nodal involvement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0441949
creatinine < 1.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
not pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide)
Description

Fertility Contraceptive methods | Fertility Contraception, Barrier | Thalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0015895
UMLS CUI [2,2]
C0004764
UMLS CUI [3]
C0039736
no other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin
Description

Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
UMLS CUI [3]
C0007117
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
grade 3-4 cardiac failure
Description

Heart failure | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
lvef that is less than ≥ 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
psychological, familial, sociological, or geographical conditions that would preclude study compliance
Description

Condition Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
known history of hiv or aids
Description

HIV | Acquired Immunodeficiency Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0001175
hepatitis or hepatitis b virus infection
Description

Hepatitis | Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0019163
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
Description

Prior Chemotherapy Mantle cell lymphoma | Prior Immunotherapy Mantle cell lymphoma | prior radiation therapy Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0334634
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0334634
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0334634

Similar models

Eligibility Lymphoma NCT00450801

  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00450801
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
disease characteristic
Item
disease characteristics:
boolean
C0599878 (UMLS CUI [1])
Mantle cell lymphoma
Item
histologically confirmed mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
TNM clinical staging
Item
all stages allowed
boolean
C3258246 (UMLS CUI [1])
Disease untreated
Item
previously untreated disease
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Central Nervous System Involvement
Item
no cns involvement
boolean
C4050309 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Lymphomatous nodal involvement
Item
sgot and/or sgpt < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0441949 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine < 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods | Fertility Contraception, Barrier | Thalidomide
Item
fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide)
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015895 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0039736 (UMLS CUI [3])
Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma
Item
no other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Heart failure | New York Heart Association Classification
Item
grade 3-4 cardiac failure
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Left ventricular ejection fraction
Item
lvef that is less than ≥ 50%
boolean
C0428772 (UMLS CUI [1])
Condition Excludes Protocol Compliance
Item
psychological, familial, sociological, or geographical conditions that would preclude study compliance
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
HIV | Acquired Immunodeficiency Syndrome
Item
known history of hiv or aids
boolean
C0019682 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Hepatitis | Hepatitis B
Item
hepatitis or hepatitis b virus infection
boolean
C0019158 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Prior Chemotherapy Mantle cell lymphoma | Prior Immunotherapy Mantle cell lymphoma | prior radiation therapy Mantle cell lymphoma
Item
any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
boolean
C1514457 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
C1514461 (UMLS CUI [2,1])
C0334634 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0334634 (UMLS CUI [3,2])

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

Fields marked with * are required.

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