ID

12144

Descripción

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

Palabras clave

Versiones (2)
  1. 30/9/15 30/9/15 -
  2. 28/10/15 28/10/15 -
Subido en

30 de septiembre de 2015

DOI

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Licencia

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

Inglés

Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 formularios  
Adverse event
Descripción

Adverse event

Alias
UMLS CUI-1
C0877248
Name adverse event
Descripción

Name adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Date of Onset
Descripción

Adverse Event Onset Date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985916
dd/mm/yy
Serious Adverse Event
Descripción

Serious Adverse Event

Tipo de datos

boolean

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

Adverse event

Tipo de datos

boolean

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

Adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
CTCAE grade
Descripción

Initial intensity

Tipo de datos

integer

Test drug adjustment
Descripción

Test drug adjustment

Tipo de datos

integer

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

Adverse event treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2981656
CTCAE grade
Descripción

Most extreme intensity

Tipo de datos

integer

Adverse event
Descripción

Relationship to study drugs

Tipo de datos

integer

Outcome
Descripción

Adverse Event Outcome

Tipo de datos

text

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

ResolvedDate

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2699488
dd/mm/yy
Adverse Event Comment
Descripción

Adverse Event Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Adverse event treatments
Descripción

Adverse event treatments

Alias
UMLS CUI-1
C2981656
Name of treatment
Descripción

treatment name

Tipo de datos

text

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

Treatment Start Date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C3173309
dd/mm/yy
Treatment End Date
Descripción

Treatment End Date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C1531784
dd/mm/yy
Treatment Ongoing
Descripción

Treatment Ongoing at final contact

Tipo de datos

boolean

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Similar models

Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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