ID

22100

Descrição

A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-Cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00389051

Link

https://clinicaltrials.gov/show/NCT00389051

Palavras-chave

Versões (1)
  1. 19/05/2017 19/05/2017 -
Transferido a

19 de maio de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Non-Hodgkin's Lymphoma NCT00389051

Inglês

Eligibility Non-Hodgkin's Lymphoma NCT00389051

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
indolent b cell non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.
Descrição

B-Cell Lymphoma indolent | Prior Therapy | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C0234227
UMLS CUI [2]
C1514463
UMLS CUI [3]
C0079399
patients with histologically or cytologically confirmed indolent b cell non-hodgkin's lymphoma.
Descrição

B-Cell Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079731
patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
Descrição

Therapeutic procedure Absent | Chemotherapy | antibody therapy | Therapeutic radiology procedure | Prior Therapy Effects of Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0281176
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C1704420
UMLS CUI [5,3]
C0332268
patients aged from 20 to less than 75 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients who had agreed in-patient during first course therapy.
Descrição

First line treatment Inpatient Agree

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0021562
UMLS CUI [1,3]
C3641827
patients from whom written consent to participate in this study has been obtained.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria:patients who meet any of the following criteria will be excluded.
Descrição

Exclusion Criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
patients with apparent infections.
Descrição

Communicable Diseases apparent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0750489
patients with serious complications (hepatic failure or renal failure).
Descrição

Complication Serious | Liver Failure | Kidney Failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0035078
patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
Descrição

Heart failure Serious Complication | Heart failure Serious | Myocardial Infarction | Myocardial Ischemia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0009566
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0151744
patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
Descrição

Digestive symptom Serious | Nausea | Vomiting | Diarrhea

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0476288
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0027497
UMLS CUI [3]
C0042963
UMLS CUI [4]
C0011991
patients who are known to be positive for hbv, hcv or hic.
Descrição

Hepatitis B positive | Hepatitis C positive | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
patients receiving other investigational drugs within 3 months before registration in the study.
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
patients with allogenic transplant.
Descrição

Transplantation, Homologous

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040739
women who are pregnant, of childbearing potential, or lactating.
Descrição

Pregnancy | Childbearing Potential | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
patients who do not agree to contraception.
Descrição

Contraceptive methods Disagree

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641828
otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
Voltar ao início da página

Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00389051

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphoma indolent | Prior Therapy | Gender
Item
indolent b cell non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.
boolean
C0079731 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
B-Cell Lymphoma
Item
patients with histologically or cytologically confirmed indolent b cell non-hodgkin's lymphoma.
boolean
C0079731 (UMLS CUI [1])
Therapeutic procedure Absent | Chemotherapy | antibody therapy | Therapeutic radiology procedure | Prior Therapy Effects of Lacking
Item
patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
boolean
C0087111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0281176 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1514463 (UMLS CUI [5,1])
C1704420 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Age
Item
patients aged from 20 to less than 75 years.
boolean
C0001779 (UMLS CUI [1])
First line treatment Inpatient Agree
Item
patients who had agreed in-patient during first course therapy.
boolean
C1708063 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
Informed Consent
Item
patients from whom written consent to participate in this study has been obtained.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria:patients who meet any of the following criteria will be excluded.
boolean
C0680251 (UMLS CUI [1])
Communicable Diseases apparent
Item
patients with apparent infections.
boolean
C0009450 (UMLS CUI [1,1])
C0750489 (UMLS CUI [1,2])
Complication Serious | Liver Failure | Kidney Failure
Item
patients with serious complications (hepatic failure or renal failure).
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
Heart failure Serious Complication | Heart failure Serious | Myocardial Infarction | Myocardial Ischemia
Item
patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
boolean
C0018801 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
Digestive symptom Serious | Nausea | Vomiting | Diarrhea
Item
patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
boolean
C0476288 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
C0011991 (UMLS CUI [4])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity
Item
patients who are known to be positive for hbv, hcv or hic.
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Investigational New Drugs
Item
patients receiving other investigational drugs within 3 months before registration in the study.
boolean
C0013230 (UMLS CUI [1])
Transplantation, Homologous
Item
patients with allogenic transplant.
boolean
C0040739 (UMLS CUI [1])
Pregnancy | Childbearing Potential | Breast Feeding
Item
women who are pregnant, of childbearing potential, or lactating.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Contraceptive methods Disagree
Item
patients who do not agree to contraception.
boolean
C0700589 (UMLS CUI [1,1])
C3641828 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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