ID

41984

Beskrivning

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

Nyckelord

Versioner (8)
  1. 2015-03-31 2015-03-31 - Martin Dugas
  2. 2015-04-02 2015-04-02 - Martin Dugas
  3. 2015-04-09 2015-04-09 -
  4. 2015-06-08 2015-06-08 -
  5. 2015-10-27 2015-10-27 -
  6. 2015-11-03 2015-11-03 - Julian Varghese
  7. 2015-11-03 2015-11-03 - Julian Varghese
  8. 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Uppladdad den

15 mars 2021

DOI

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Licens

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

Engelsk

Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051

1 Formulär  
Demographics
Beskrivning

Demographics

Alias
UMLS CUI-1
C1704791
Date of visit
Beskrivning

Date of visit

Datatyp

date

Måttenheter
  • ddmmyy
Alias
UMLS CUI-1
C1320303
ddmmyy
Patient initials
Beskrivning

Patient initials

Datatyp

text

Måttenheter
  • FML
Alias
UMLS CUI-1
C2986440
FML
Birth Date
Beskrivning

Birth Date

Datatyp

date

Måttenheter
  • ddmmyy
Alias
UMLS CUI-1
C0421451
ddmmyy
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI-1
C0079399
Female reproductive status
Beskrivning

Female reproductive status

Datatyp

integer

Alias
UMLS CUI [1]
C1831019
contraceptive protection, specify
Beskrivning

contraceptive protection, specify

Datatyp

text

Alias
UMLS CUI [1]
C0700589
Race
Beskrivning

Race

Datatyp

integer

Alias
UMLS CUI-1
C0034510
Specify race
Beskrivning

Specify race

Datatyp

text

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

Serum pregnancy test (only females of childbearing potential)

Alias
UMLS CUI-1
C0430060
Date of pregnancy test
Beskrivning

Date of pregnancy test

Datatyp

date

Måttenheter
  • ddmmyy
Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C0011008
ddmmyy
Pregnancy Test
Beskrivning

Pregnancy Test

Datatyp

integer

Alias
UMLS CUI-1
C0430060
Previous or current diseases other than CLL
Beskrivning

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?
Beskrivning

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?

Datatyp

integer

Alias
UMLS CUI [1]
C2985739
Disease
Beskrivning

Disease

Datatyp

text

Alias
UMLS CUI-1
C0012634
active
Beskrivning

active

Datatyp

boolean

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

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?
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1]
C0814462
Name of treatment (or medical procedure)
Beskrivning

Name of treatment (or medical procedure)

Datatyp

text

Alias
UMLS CUI-1
C0087111
Previous treatments/medical procedures/chemotherapy related to CLL
Beskrivning

Previous treatments/medical procedures/chemotherapy related to CLL

Alias
UMLS CUI-1
C0814462
Name of treatment
Beskrivning

Name of treatment

Datatyp

text

Alias
UMLS CUI [1]
C3665472
Start date
Beskrivning

Start date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0808070
dd/mm/yy
End date
Beskrivning

End date

Datatyp

date

Alias
UMLS CUI-1
C0806020
Best response
Beskrivning

Best response

Datatyp

integer

Alias
UMLS CUI-1
C2986560
Previous treatments radiotherapy
Beskrivning

Previous treatments radiotherapy

site of radiotherapy
Beskrivning

site of radiotherapy

Datatyp

integer

Alias
UMLS CUI [1]
C1997599
Total dose
Beskrivning

Total dose

Datatyp

float

Måttenheter
  • Gy
Alias
UMLS CUI [1]
C2986497
Gy
Start date
Beskrivning

Start date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Beskrivning

End date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Surgery
Beskrivning

Surgery

Alias
UMLS CUI-1
C0543467
Surgical procedure
Beskrivning

Surgical procedure

Datatyp

text

Alias
UMLS CUI-1
C0543467
Date of Surgery
Beskrivning

Date of Surgery

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C1628561
dd/mm/yy
Other treatment
Beskrivning

Other treatment

Name of treatment
Beskrivning

Name of treatment

Datatyp

text

Alias
UMLS CUI-1
C0087111
Start date
Beskrivning

Start date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0808070
dd/mm/yy
End date
Beskrivning

End date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0806020
dd/mm/yy
Tillbaka till toppen

Similar models

Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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