Informações:
Falhas:
ID
21521
Descrição
Rituximab and CVP Plus Interferon for Follicular Non Hodgkins Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00842114
Link
https://clinicaltrials.gov/show/NCT00842114
Palavras-chave
Versões (1)
- 25/04/2017 25/04/2017 -
Transferido a
25 de abril de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00842114
Eligibility Non-Hodgkin's Lymphoma NCT00842114
- StudyEvent: Eligibility
Similar models
Eligibility Non-Hodgkin's Lymphoma NCT00842114
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
age 18 years-75 years
boolean
C0001779 (UMLS CUI [1])
Lymphoma
Item
pathologically confirmed low grade, follicular b cell lymphoma (who classification follicular grades 1 and 2) , marginal zone lymphoma or lymphocytic lymphoma (excluding cll and mcl)
boolean
C0024299 (UMLS CUI [1])
Follicular Lymphoma International Prognostic Index
Item
flipi score ≥ 2
boolean
C4040298 (UMLS CUI [1])
Prior chemotherapy or radiation
Item
chemotherapy-naïve patients. previous radiation therapy is allowed, but should have been limited.
boolean
C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
C1514457 (UMLS CUI [2])
Liver and Kidney Function
Item
adequate hepatic (bilirubin or alt/ast < 2,5 times unl) and renal function, except for those directly disease-related
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232804 (UMLS CUI [2])
Performance Status
Item
performance status grade 0 to 3
boolean
C1518965 (UMLS CUI [1])
Biopsy Material for Pathology and Molecular Biology Studies
Item
frozen biopsy material obtained at relapse or disease progression should be available for central pathology review and molecular biology studies
boolean
C1292533 (UMLS CUI [1,1])
C0030664 (UMLS CUI [1,2])
C1292533 (UMLS CUI [2,1])
C0026376 (UMLS CUI [2,2])
C0030664 (UMLS CUI [1,2])
C1292533 (UMLS CUI [2,1])
C0026376 (UMLS CUI [2,2])
Informed Consent
Item
patient information and written informed consent
boolean
C0021430 (UMLS CUI [1])
Prior Malignancy
Item
previous evolutive malignancy within 5 years of study entry
boolean
C2735088 (UMLS CUI [1])
Prior Chemotherapy
Item
prior chemotherapy treatment
boolean
C1514457 (UMLS CUI [1])
Cardiac Disease
Item
clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months of study entry
boolean
C0018799 (UMLS CUI [1])
HIV, HBV, HCV
Item
known positivity for hiv, vhb or vhc
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Gynaecological Status
Item
pregnant or lactating women. women of childbearing potential, and all men, unwilling to take appropriate contraceptive measures during and for at least 12 months after cessation of therapy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Comorbidity
Item
any uncontrolled serious non malignant condition or infection which would likely compromise the study objectives
boolean
C0009488 (UMLS CUI [1])
Thyroid dysfunction
Item
non controlled thyroid disfunction
boolean
C0348024 (UMLS CUI [1])
Autoimmune disease
Item
severe autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Neuropsychiatric disease
Item
patients with history of severe neuropsychiatric disease
boolean
C3203509 (UMLS CUI [1])