ID

41984

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

15. März 2021

DOI

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Lizenz

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

Englisch

Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051

1 Formulare  
Demographics
Beschreibung

Demographics

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

Alias
UMLS CUI [1]
C0700589
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI-1
C0034510
Specify race
Beschreibung

Specify race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Serum pregnancy test (only females of childbearing potential)
Beschreibung

Serum pregnancy test (only females of childbearing potential)

Alias
UMLS CUI-1
C0430060
Date of pregnancy test
Beschreibung

Date of pregnancy test

Datentyp

date

Maßeinheiten
  • ddmmyy
Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C0011008
ddmmyy
Pregnancy Test
Beschreibung

Pregnancy Test

Datentyp

integer

Alias
UMLS CUI-1
C0430060
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]
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
Previous treatments/medical procedures/chemotherapy related to CLL
Beschreibung

Previous treatments/medical procedures/chemotherapy related to CLL

Alias
UMLS CUI-1
C0814462
Name of treatment
Beschreibung

Name of treatment

Datentyp

text

Alias
UMLS CUI [1]
C3665472
Start date
Beschreibung

Start date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI-1
C0808070
dd/mm/yy
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI-1
C0806020
Best response
Beschreibung

Best response

Datentyp

integer

Alias
UMLS CUI-1
C2986560
Previous treatments radiotherapy
Beschreibung

Previous treatments radiotherapy

site of radiotherapy
Beschreibung

site of radiotherapy

Datentyp

integer

Alias
UMLS CUI [1]
C1997599
Total dose
Beschreibung

Total dose

Datentyp

float

Maßeinheiten
  • Gy
Alias
UMLS CUI [1]
C2986497
Gy
Start date
Beschreibung

Start date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Beschreibung

End date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Surgery
Beschreibung

Surgery

Alias
UMLS CUI-1
C0543467
Surgical procedure
Beschreibung

Surgical procedure

Datentyp

text

Alias
UMLS CUI-1
C0543467
Date of Surgery
Beschreibung

Date of Surgery

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C1628561
dd/mm/yy
Other treatment
Beschreibung

Other treatment

Name of treatment
Beschreibung

Name of treatment

Datentyp

text

Alias
UMLS CUI-1
C0087111
Start date
Beschreibung

Start date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI-1
C0808070
dd/mm/yy
End date
Beschreibung

End date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI-1
C0806020
dd/mm/yy
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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
Demographics
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
contraceptive protection, specify
text
C0700589 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI-1)
Race
Code List
Race
CL Item
caucasian/white (1)
C0007457 (UMLS CUI-1)
CL Item
black (2)
C0005680 (UMLS CUI-1)
CL Item
oriental (3)
C0078988 (UMLS CUI-1)
CL Item
other (specify) (4)
C0205394 (UMLS CUI-1)
Other race
Item
Specify race
text
C0034510 (UMLS CUI [1])
Item Group
Serum pregnancy test (only females of childbearing potential)
C0430060 (UMLS CUI-1)
pregnancy test date
Item
Date of pregnancy test
date
C0430060 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy Test
integer
C0430060 (UMLS CUI-1)
Pregnancy Test
Code List
Pregnancy Test
CL Item
negative (0)
C0205160 (UMLS CUI-1)
CL Item
positive (-> patient must be excluded from study) (1)
C1446409 (UMLS CUI-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
C2985739 (UMLS CUI [1])
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)
C1705108 (UMLS CUI-1)
CL Item
no (0)
C1298908 (UMLS CUI-1)
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
C3665472 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI-1)
End date
Item
End date
date
C0806020 (UMLS CUI-1)
Item
Best response
integer
C2986560 (UMLS CUI-1)
Best response
Code List
Best response
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)
Item Group
Previous treatments radiotherapy
site of radiotherapy
Item
site of radiotherapy
integer
C1997599 (UMLS CUI [1])
Total dose
Item
Total dose
float
C2986497 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item Group
Surgery
C0543467 (UMLS CUI-1)
Surgical procedure
Item
Surgical procedure
text
C0543467 (UMLS CUI-1)
Date
Item
Date of Surgery
date
C1628561 (UMLS CUI [1])
Item Group
Other treatment
Name of treatment
Item
Name of treatment
text
C0087111 (UMLS CUI-1)
Start date
Item
Start date
date
C0808070 (UMLS CUI-1)
End date
Item
End date
date
C0806020 (UMLS CUI-1)
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