ID

12241

Beschrijving

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

Trefwoorden

Versies (2)
  1. 30-09-15 30-09-15 -
  2. 28-10-15 28-10-15 -
Geüploaded op

28 oktober 2015

DOI

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Licentie

Creative Commons BY-NC 3.0
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CLL Adverse Event BO17072 NCT00090051

Engels

Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulieren  
Adverse event
Beschrijving

Adverse event

Name adverse event
Beschrijving

Name adverse event

Datatype

integer

Alias
UMLS CUI [1]
C0877248
Date of Onset
Beschrijving

Adverse Event Onset Date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985916
dd/mm/yy
Serious Adverse Event
Beschrijving

Serious Adverse Event

Datatype

boolean

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

Adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C1314901
Did this event start within 24 hours of finishing a MabThera® infusion?
Beschrijving

Adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
CTCAE grade
Beschrijving

Initial intensity

Datatype

integer

Alias
UMLS CUI [1]
C1517874
Test drug adjustment
Beschrijving

Test drug adjustment

Datatype

integer

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

Adverse event treatment

Datatype

boolean

Alias
UMLS CUI [1]
C2981656
Most extreme intensity CTCAE grade
Beschrijving

Most extreme intensity CTCAE grade

Datatype

integer

Alias
UMLS CUI [1]
C1517874
Adverse event
Beschrijving

Relationship to study drugs

Datatype

integer

Adverse Event Outcome
Beschrijving

Adverse Event Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586
Resolved Date
Beschrijving

Resolved Date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Adverse Event Comment
Beschrijving

Adverse Event Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Adverse event treatments
Beschrijving

Adverse event treatments

Name of treatment
Beschrijving

Name of treatment

Datatype

integer

Alias
UMLS CUI [1]
C2826274
Treatment Start Date
Beschrijving

Treatment Start Date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C3173309
dd/mm/yy
Treatment End Date
Beschrijving

Treatment End Date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C1531784
dd/mm/yy
Treatment Ongoing
Beschrijving

Treatment Ongoing at final contact

Datatype

boolean

Alias
UMLS CUI [1]
C2091305
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Similar models

Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adverse event
Name adverse event
Item
Name adverse event
integer
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
C1314901 (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
C1517874 (UMLS CUI [1])
Initial intensity
Code List
CTCAE grade
CL Item
CTCAE grade 1 (1)
C1556202 (UMLS CUI-1)
CL Item
CTCAE grade 2 (2)
C1556203 (UMLS CUI-1)
CL Item
CTCAE grade 3 (3)
C1556204 (UMLS CUI-1)
CL Item
CTCAE grade 4 (4)
C1556205 (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
Most extreme intensity CTCAE grade
integer
C1517874 (UMLS CUI [1])
Initial intensity
Code List
Most extreme intensity CTCAE grade
CL Item
CTCAE grade 1 (1)
C1556202 (UMLS CUI-1)
CL Item
CTCAE grade 2 (2)
C1556203 (UMLS CUI-1)
CL Item
CTCAE grade 3 (3)
C1556204 (UMLS CUI-1)
CL Item
CTCAE grade 4 (4)
C1556205 (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
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event Outcome
CL Item
resolved, no sequelae (1)
CL Item
resolved, with sequelae (2)
CL Item
unresoved (3)
CL Item
death (4)
Resolved Date
Item
Resolved Date
date
C0011008 (UMLS CUI [1])
Adverse Event Comment
Item
Adverse Event Comment
text
C0947611 (UMLS CUI [1])
Item Group
Adverse event treatments
Name of treatment
Item
Name of treatment
integer
C2826274 (UMLS CUI [1])
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
Treatment Ongoing
boolean
C2091305 (UMLS CUI [1])
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