ID

12252

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 Treatments given for an adverse event should be recorded on the appropriate “Adverse event” page. Treatments given for prophylaxis or treatment of abnormal laboratory values (e.g. blood cells, potassium supplements, etc.) should be recorded on this page. List any treatments continuing at screen or that have begun since screen (or medical procedures performed) that are not recorded on Adverse event pages.

Keywords

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

October 28, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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CLL Concomitant Treatments BO17072 NCT00090051

Concomitant Treatmants Chronic Lymphocytic Leukemia BO17072 NCT00090051

Concomitant treatments (or medical procedures) other than for CLL
Description

Concomitant treatments (or medical procedures) other than for CLL

Treatments given for an adverse event should be recorded on the appropriate “Adverse event” page. Treatments given for prophylaxis or treatment of abnormal laboratory values (e.g. blood cells, potassium supplements, etc.) should be recorded on this page. List any treatments continuing at screen or that have begun since screen (or medical procedures performed) that are not recorded on Adverse event pages.
Description

Info

Data type

text

Name of concomitant treatment
Description

Name of treatment

Data type

text

Alias
UMLS CUI [1]
C1707479
Total Daily Dose of Agent (or Drug)
Description

Concomitant Medication Daily Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C2826638
mg
Start date
Description

Concomitant Medication Start Date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2826734
dd/mm/yy
End Date
Description

Concomitant Medication End Date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2826744
dd/mm/yy
Ongoing
Description

Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Concomitant Medication Use Reason
Description

Concomitant Medication Use Reason

Data type

text

Alias
UMLS CUI [1]
C2347852

Similar models

Concomitant Treatmants Chronic Lymphocytic Leukemia BO17072 NCT00090051

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant treatments (or medical procedures) other than for CLL
Info
Item
Treatments given for an adverse event should be recorded on the appropriate “Adverse event” page. Treatments given for prophylaxis or treatment of abnormal laboratory values (e.g. blood cells, potassium supplements, etc.) should be recorded on this page. List any treatments continuing at screen or that have begun since screen (or medical procedures performed) that are not recorded on Adverse event pages.
text
Name of treatment
Item
Name of concomitant treatment
text
C1707479 (UMLS CUI [1])
Concomitant Medication Daily Dose
Item
Total Daily Dose of Agent (or Drug)
float
C2826638 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication Use Reason
Item
Concomitant Medication Use Reason
text
C2347852 (UMLS CUI [1])

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