ID

12144

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). FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients NCT00090051 Roche BO17072

Keywords

Versions (2)
  1. 9/30/15 9/30/15 -
  2. 10/28/15 10/28/15 -
Uploaded on

September 30, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CLL Adverse Event NCT00090051 BO17072

English

Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 forms  
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Name adverse event
Description

Name adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Date of Onset
Description

Adverse Event Onset Date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985916
dd/mm/yy
Serious Adverse Event
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Did this event start during a MabThera® infusion?
Description

Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Did this event start within 24 hours of finishing a MabThera® infusion?
Description

Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
CTCAE grade
Description

Initial intensity

Data type

integer

Test drug adjustment
Description

Test drug adjustment

Data type

integer

Alias
UMLS CUI [1]
C0376209
Was treatment given for this event
Description

Adverse event treatment

Data type

boolean

Alias
UMLS CUI [1]
C2981656
CTCAE grade
Description

Most extreme intensity

Data type

integer

Adverse event
Description

Relationship to study drugs

Data type

integer

Outcome
Description

Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1274040
Resolved Date
Description

ResolvedDate

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2699488
dd/mm/yy
Adverse Event Comment
Description

Adverse Event Comment

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse event treatments
Description

Adverse event treatments

Alias
UMLS CUI-1
C2981656
Name of treatment
Description

treatment name

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0027365
Treatment Start Date
Description

Treatment Start Date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C3173309
dd/mm/yy
Treatment End Date
Description

Treatment End Date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C1531784
dd/mm/yy
Treatment Ongoing
Description

Treatment Ongoing at final contact

Data type

boolean

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Similar models

Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Name adverse event
Item
text
C0877248 (UMLS CUI [1])
Adverse Event Onset Date
Item
Date of Onset
date
C2985916 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1])
Adverse Event
Item
Did this event start during a MabThera® infusion?
boolean
C0877248 (UMLS CUI [1])
Adverse event
Item
Did this event start within 24 hours of finishing a MabThera® infusion?
boolean
C0877248 (UMLS CUI [1])
Item
CTCAE grade
integer
Initial intensity
Code List
CTCAE grade
CL Item
CTCAE grade 1 (1)
C1513302 (UMLS CUI-1)
CL Item
CTCAE grade 2 (2)
C1513374 (UMLS CUI-1)
CL Item
CTCAE grade 3 (3)
C1519275 (UMLS CUI-1)
CL Item
CTCAE grade 4 (4)
C1517874 (UMLS CUI-1)
Item
Test drug adjustment
integer
C0376209 (UMLS CUI [1])
Test drug adjustment
Code List
Test drug adjustment
CL Item
none (1)
C0549184 (UMLS CUI-1)
CL Item
dosage modified/interrupted (2)
C0392747 (UMLS CUI-1)
CL Item
discontinued (3)
C1444662 (UMLS CUI-1)
Adverse event treatment
Item
Was treatment given for this event
boolean
C2981656 (UMLS CUI [1])
Item
CTCAE grade
integer
Initial intensity
Code List
CTCAE grade
CL Item
CTCAE grade 1 (1)
C1513302 (UMLS CUI-1)
CL Item
CTCAE grade 2 (2)
C1513374 (UMLS CUI-1)
CL Item
CTCAE grade 3 (3)
C1519275 (UMLS CUI-1)
CL Item
CTCAE grade 4 (4)
C1517874 (UMLS CUI-1)
Item
Adverse event
integer
Adverse event
Code List
Adverse event
CL Item
unrelated (1)
C0445356 (UMLS CUI-1)
CL Item
remote (2)
C0205157 (UMLS CUI-1)
CL Item
possible (3)
C0332149 (UMLS CUI-1)
CL Item
probable (4)
C1709683 (UMLS CUI-1)
Item
Outcome
text
C0877248 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Adverse Event Outcome
Code List
Outcome
CL Item
resolved, no sequelae (1)
CL Item
resolved, with sequelae (2)
CL Item
unresoved (3)
CL Item
death (4)
ResolvedDate
Item
Resolved Date
date
C0877248 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Adverse Event Comment
Item
Adverse Event Comment
text
C0877248 (UMLS CUI [1])
Item Group
C2981656 (UMLS CUI-1)
treatment name
Item
Name of treatment
text
C0087111 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Treatment Start Date
Item
Treatment Start Date
date
C3173309 (UMLS CUI [1])
Treatment End Date
Item
Treatment End Date
date
C1531784 (UMLS CUI [1])
Treatment Ongoing
Item
boolean
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