ID

10109

Beschreibung

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

Stichworte

Versionen (8)
  1. 31.03.15 31.03.15 - Martin Dugas
  2. 02.04.15 02.04.15 - Martin Dugas
  3. 09.04.15 09.04.15 -
  4. 08.06.15 08.06.15 -
  5. 27.10.15 27.10.15 -
  6. 03.11.15 03.11.15 - Julian Varghese
  7. 03.11.15 03.11.15 - Julian Varghese
  8. 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Hochgeladen am

31. März 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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CLL Demographics and Medical History NCT00090051 BO17072

Englisch

Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051

1 Formulare  
Personal data
Beschreibung

Personal data

Alias
UMLS CUI-1
C1704791
Date of visit
Beschreibung

Date of visit

Datentyp

date

Maßeinheiten
  • ddmmyy
Alias
UMLS CUI-1
C1320303
ddmmyy
Patient initials
Beschreibung

Patient initials

Datentyp

text

Maßeinheiten
  • FML
Alias
UMLS CUI-1
C2986440
FML
Birth Date
Beschreibung

Birth Date

Datentyp

date

Maßeinheiten
  • ddmmyy
Alias
UMLS CUI-1
C0421451
ddmmyy
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI-1
C0079399
Female reproductive status
Beschreibung

Female reproductive status

Datentyp

integer

Alias
UMLS CUI-1
C1831019
contraceptive protection, specify
Beschreibung

contraceptive protection, specify

Datentyp

text

Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI-1
C0034510
Specify race
Beschreibung

Specify race

Datentyp

text

Serum pregnancy test (only females of childbearing potential)
Beschreibung

Serum pregnancy test (only females of childbearing potential)

Alias
UMLS CUI-1
C0032976
Date of pregnancy test
Beschreibung

Date of pregnancy test

Datentyp

date

Maßeinheiten
  • ddmmyy
Alias
UMLS CUI-1
C0032976
UMLS CUI-2
C0011008
ddmmyy
Pregnancy Test
Beschreibung

Pregnancy Test

Datentyp

integer

Alias
UMLS CUI-1
C0032976
Previous or current diseases other than CLL
Beschreibung

Previous or current diseases other than CLL

Alias
UMLS CUI-1
C0262926
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?
Beschreibung

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?

Datentyp

integer

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C2985739
Disease
Beschreibung

Disease

Datentyp

text

Alias
UMLS CUI-1
C0012634
active
Beschreibung

active

Datentyp

boolean

Alias
UMLS CUI-1
C0205177
Previous treatments not associated with CLL
Beschreibung

Previous treatments not associated with CLL

Alias
UMLS CUI-1
C0814462
Have there been any previous drug treatments (or medical procedures) not associated with CLL completed in the last month?
Beschreibung

Have there been any previous drug treatments (or medical procedures) not associated with CLL completed in the last month?

Datentyp

integer

Alias
UMLS CUI-1
C0814462
Name of treatment (or medical procedure)
Beschreibung

Name of treatment (or medical procedure)

Datentyp

text

Alias
UMLS CUI-1
C0087111
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Ähnliche Modelle

Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Personal data
C1704791 (UMLS CUI-1)
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)
Item
Sex
text
C0079399 (UMLS CUI-1)
Sex
Code List
Sex
CL Item
male (m)
CL Item
female (f)
Item
Female reproductive status
integer
C1831019 (UMLS CUI-1)
Female reproductive status
Code List
Female reproductive status
CL Item
childbearing potential without contraceptive protection (-> exclusion) (1)
C3831118 (UMLS CUI-1)
C0700589 (UMLS CUI-2)
CL Item
childbearing potential with contraceptive protection (-> specify) (2)
C3831118 (UMLS CUI-1)
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
Item
Race
integer
C0034510 (UMLS CUI-1)
Race
Code List
Race
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)
Item
Pregnancy Test
integer
C0032976 (UMLS CUI-1)
Pregnancy Test
Code List
Pregnancy Test
CL Item
negative (0)
CL Item
positive (-> patient must be excluded from study) (1)
Item Group
Previous or current diseases other than CLL
C0262926 (UMLS CUI-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)
Disease, clinically significant
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 Group
Previous treatments not associated with CLL
C0814462 (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)
Previous treatments
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)
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