Eligibility Non-Hodgkin's Lymphoma NCT00794638

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StudyEvent: Eligibility
1. Eligibility Non-Hodgkin's Lymphoma NCT00794638

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Aggressive Non-Hodgkin Lymphoma | Prior Therapy

Item

aggressive b-cell non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.

boolean

C1332225 (UMLS CUI [1])
C1514463 (UMLS CUI [2])

B-Cell Lymphoma CD20 positive

Item

patients with the following histologically confirmed cd20(+) b-cell non-hodgkin's lymphoma:

boolean

C0079731 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])

Diffuse Large B-Cell Lymphoma

Item

1. diffuse large b-cell lymphoma

boolean

C0079744 (UMLS CUI [1])

Mantle cell lymphoma

Item

2. mantle cell lymphoma

boolean

C0334634 (UMLS CUI [1])

Transformation Lymphoma

Item

3. transformed lymphoma

boolean

C0040682 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])

Follicular Lymphoma Ann Arbor lymphoma staging system

Item

4. follicular lymphoma (grade 3)

boolean

C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])

Complete remission failed Prior Chemotherapy | Recurrent disease Post Complete remission | Recurrent disease Post Partial response

Item

fail to cr in prior chemotherapy, or relapse following cr or recurrence following pr.

boolean

C0677874 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0677874 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1521726 (UMLS CUI [3,3])

Absence Effect Due to Prior Therapy | Chemotherapy | Antibody therapy | Therapeutic radiology procedure

Item

patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.

boolean

C0332197 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2])
C0281176 (UMLS CUI [3])
C1522449 (UMLS CUI [4])

Age

Item

patients aged from 20 to 75 years at the time informed consent is obtained

boolean

C0001779 (UMLS CUI [1])

Item

patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)

boolean

C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232164 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C0232804 (UMLS CUI [6])

Hospitalization Possible

Item

patients who can be hospitalized during the first cycle

boolean

C0019993 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])

Informed Consent

Item

patients capable of personally giving voluntary informed consent in writing to participate in the study

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Criteria Fulfill

Item

patients who meet any of the following criteria will be excluded.

boolean

C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])

Complications Serious | Liver Failure | Kidney Failure

Item

patients with serious complications (hepatic or renal failure)

boolean

C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2])
C0035078 (UMLS CUI [3])

Complications Heart Disease Serious | Heart Disease Serious | Myocardial Infarction | Myocardial Ischemia

Item

patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)

boolean

C0009566 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0151744 (UMLS CUI [4])

Gastrointestinal symptom Serious | Nausea Severe | Vomiting Severe | Severe diarrhea

Item

patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)

boolean

C0426576 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0042963 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1443924 (UMLS CUI [4])

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive

Item

patients positive for hbs antigen, hcv antibody, or hiv antibody

boolean

C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])

Investigational New Drugs | Drugs, Non-Prescription

Item

patients who received other investigational drug or unapproved medication within 3 months before registration in this study

boolean

C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])

Hematopoietic stem cell transplantation | Radioimmunotherapy

Item

patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy

boolean

C0472699 (UMLS CUI [1])
C0085101 (UMLS CUI [2])

Pregnancy | Childbearing Potential | Breast Feeding

Item

patients who are pregnant, of childbearing potential, or lactating

boolean

C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])

Contraceptive methods Unwilling

Item

patients, whether male or female, who do not agree to contraception

boolean

C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])

Study Subject Participation Status Inappropriate

Item

patients otherwise judged by investigator or sub investigator to be unsuitable

boolean

C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])

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Eligibility Non-Hodgkin's Lymphoma NCT00794638