ID

12293

Description

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

Keywords

Versions (8)
  1. 3/31/15 3/31/15 - Martin Dugas
  2. 4/2/15 4/2/15 - Martin Dugas
  3. 4/9/15 4/9/15 -
  4. 6/8/15 6/8/15 -
  5. 10/27/15 10/27/15 -
  6. 11/3/15 11/3/15 - Julian Varghese
  7. 11/3/15 11/3/15 - Julian Varghese
  8. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

November 3, 2015

DOI

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License

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

English

Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051

1 forms  
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1698647
Date of visit
Description

Date of visit

Data type

date

Measurement units
  • ddmmyy
Alias
UMLS CUI-1
C1320303
ddmmyy
Patient initials
Description

Patient initials

Data type

text

Measurement units
  • FML
Alias
UMLS CUI-1
C2986440
FML
Birth Date
Description

Birth Date

Data type

date

Measurement units
  • ddmmyy
Alias
UMLS CUI-1
C0421451
ddmmyy
Sex
Description

Sex

Data type

text

Alias
UMLS CUI-1
C0079399
Female reproductive status
Description

Female reproductive status

Data type

integer

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

contraceptive protection, specify

Data type

text

Alias
UMLS CUI [1]
C0700589
Race
Description

Race

Data type

integer

Alias
UMLS CUI-1
C0034510
Specify race
Description

Specify race

Data type

text

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

Serum pregnancy test (only females of childbearing potential)

Alias
UMLS CUI-1
C0430060
Date of pregnancy test
Description

Date of pregnancy test

Data type

date

Measurement units
  • ddmmyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0430060
ddmmyy
Pregnancy Test
Description

Pregnancy Test

Data type

integer

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

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?
Description

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?

Data type

integer

Alias
UMLS CUI [1]
C2985739
Disease
Description

Disease

Data type

text

Alias
UMLS CUI-1
C0012634
active
Description

active

Data type

boolean

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

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?
Description

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

Data type

integer

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

Name of treatment (or medical procedure)

Data type

text

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

Previous treatments/medical procedures/chemotherapy related to CLL

Alias
UMLS CUI-1
C0814462
Name of treatment
Description

Name of treatment

Data type

text

Alias
UMLS CUI [1]
C3665472
Start date
Description

Start date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI-1
C0808070
dd/mm/yy
End date
Description

End date

Data type

date

Alias
UMLS CUI-1
C0806020
Best response
Description

Best response

Data type

integer

Alias
UMLS CUI-1
C2986560
Previous treatments radiotherapy
Description

Previous treatments radiotherapy

site of radiotherapy
Description

site of radiotherapy

Data type

integer

Alias
UMLS CUI [1]
C1997599
Total dose
Description

Total dose

Data type

float

Measurement units
  • Gy
Alias
UMLS CUI [1]
C2986497
Gy
Start date
Description

Start date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Description

End date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Surgery
Description

Surgery

Alias
UMLS CUI-1
C0543467
Surgical procedure
Description

Surgical procedure

Data type

text

Alias
UMLS CUI-1
C0543467
Date of Surgery
Description

Date of Surgery

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C1628561
dd/mm/yy
Other treatment
Description

Other treatment

Name of treatment
Description

Name of treatment

Data type

text

Alias
UMLS CUI-1
C0087111
Start date
Description

Start date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI-1
C0808070
dd/mm/yy
End date
Description

End date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI-1
C0806020
dd/mm/yy
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Similar models

Demographics and Medical History Chronic Lymphocytic Leukemia NCT00090051

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demographics
C1698647 (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
C0011008 (UMLS CUI [1,1])
C0430060 (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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