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ID
10119
Descripción
An open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) versus fludarabine and cyclophosphamide alone (FC) in previously treated patients with CD20 positive B-cell chronic lymphocytic leukemia (CLL). NCT00090051 Roche BO17072 FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
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Versiones (8)
- 31/3/15 31/3/15 - Martin Dugas
- 2/4/15 2/4/15 - Martin Dugas
- 9/4/15 9/4/15 -
- 8/6/15 8/6/15 -
- 27/10/15 27/10/15 -
- 3/11/15 3/11/15 - Julian Varghese
- 3/11/15 3/11/15 - Julian Varghese
- 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Subido en
2 de abril de 2015
DOI
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Licencia
Creative Commons BY-NC 3.0 Legacy
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CLL Demographics and Medical History NCT00090051 BO17072
Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051
Similar models
Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI-1)
Patient initials
Item
text
C2986440 (UMLS CUI-1)
Birth Date
Item
Birth Date
date
C0421451 (UMLS CUI-1)
CL Item
male (m)
CL Item
female (f)
CL Item
childbearing potential without contraceptive protection (-> exclusion) (1)
C3831118 (UMLS CUI-1)
C0700589 (UMLS CUI-2)
C0700589 (UMLS CUI-2)
CL Item
childbearing potential with contraceptive protection (-> specify) (2)
C3831118 (UMLS CUI-1)
C0742784 (UMLS CUI-2)
C0742784 (UMLS CUI-2)
CL Item
surgically sterilized (3)
C0015787 (UMLS CUI-1)
CL Item
postmenopausal (4)
C0232970 (UMLS CUI-1)
contraceptive protection, specify
Item
text
CL Item
caucasian/white (1)
CL Item
black (2)
CL Item
oriental (3)
CL Item
other (specify) (4)
Other race
Item
Specify race
text
Item Group
Serum pregnancy test (only females of childbearing potential)
C0032976 (UMLS CUI-1)
pregnancy test date
Item
Date of pregnancy test
date
C0032976 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
CL Item
negative (0)
CL Item
positive (-> patient must be excluded from study) (1)
Item
Are there any diseases (including allergies) that are clinically significant or for which the patient is under treatment (list treatments on treatment form) other than CLL?
integer
C0012634 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
C2985739 (UMLS CUI-2)
Code List
Are there any diseases (including allergies) that are clinically significant or for which the patient is under treatment (list treatments on treatment form) other than CLL?
CL Item
yes -> specify (1)
CL Item
no (0)
Disease
Item
Disease
text
C0012634 (UMLS CUI-1)
active
Item
boolean
C0205177 (UMLS CUI-1)
Item
Have there been any previous drug treatments (or medical procedures) not associated with CLL completed in the last month?
integer
C0814462 (UMLS CUI-1)
Code List
Have there been any previous drug treatments (or medical procedures) not associated with CLL completed in the last month?
CL Item
yes (->specify) (1)
CL Item
no (0)
Treatment
Item
Name of treatment (or medical procedure)
text
C0087111 (UMLS CUI-1)
Item Group
Previous treatments/medical procedures/chemotherapy related to CLL
C0814462 (UMLS CUI-1)
treatment name
Item
Name of treatment
text
C2826702 (UMLS CUI-1)
Start date
Item
Start date
date
C0808070 (UMLS CUI-1)
End date
Item
End date
date
C0806020 (UMLS CUI-1)
CL Item
CR (1)
C0677874 (UMLS CUI-1)
CL Item
PR (2)
C1521726 (UMLS CUI-1)
CL Item
SD (3)
C0677946 (UMLS CUI-1)
CL Item
PD (4)
C1335499 (UMLS CUI-1)
CL Item
NK/NA (5)
C0439673 (UMLS CUI-1)
site of radiotherapy
Item
site of radiotherapy
text
Total dose
Item
Total dose
float
Start date
Item
Start date
date
End date
Item
End date
date