ID

12239

Beschreibung

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

Stichworte

Versionen (2)
  1. 30.09.15 30.09.15 -
  2. 28.10.15 28.10.15 -
Hochgeladen am

28. Oktober 2015

DOI

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Creative Commons BY-NC 3.0
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CLL Cycle 3-6 FCR vs FC BO17072 NCT00090051

Englisch

Chemotherapy Cycle 3-6 of Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulare  
Administration of Rituximab
Beschreibung

Administration of Rituximab

Rituximab should be administered on the same day as Fludarabine and Cyclophosphamide administration.
Beschreibung

Info

Datentyp

text

Was administration of Rituximab delayed?
Beschreibung

Delay of Rituximab medication

Datentyp

boolean

Alias
UMLS CUI [1]
C3693346
Reason for delay
Beschreibung

Reason for delay

Datentyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

Alias
UMLS CUI [1]
C3840932
Date of first dose
Beschreibung

Date of first dose

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C3173309
dd/mm/yy
Start time of first dose
Beschreibung

Start time of first dose

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time of first dose
Beschreibung

End time of first dose

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual Dose of Rituximab
Beschreibung

Actual Dose of Rituximab

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C0393022
mg
Interrupted infusion
Beschreibung

Interrupted infusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0443239
Reason of interruption
Beschreibung

Reason of interruption

Datentyp

text

Alias
UMLS CUI [1]
C3538832
Decrease of infusion rate
Beschreibung

Decrease of infusion rate

Datentyp

boolean

Alias
UMLS CUI [1]
C2964135
Reason of decrease
Beschreibung

Reason of decrease

Datentyp

text

Alias
UMLS CUI [1]
C0547047
Completion of infusion
Beschreibung

Completion of infusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0205197
Reason of incomplete infusion
Beschreibung

Reason of incomplete infusion

Datentyp

text

Alias
UMLS CUI [1]
C0205257
Administration of Rituximab
Beschreibung

Administration of Rituximab

Rituximab should be administered on the same day as Fludarabine and Cyclophosphamide
Beschreibung

Rituximab should be administered on the same day as Fludarabine and Cyclophosphamide

Datentyp

text

Does the patient have a lymphocyte count of > 25x10e9/L?
Beschreibung

Lymphocyte count

Datentyp

boolean

Alias
UMLS CUI [1]
C0200635
Is the Rituximab dose being split over 2 days?
Beschreibung

Dosage splitting

Datentyp

boolean

Alias
UMLS CUI [1]
C0178602
Day 1
Beschreibung

Day 1

Delay of Rituximab medication
Beschreibung

Delay of Rituximab medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0393022
Reason for delay
Beschreibung

Reason for delay

Datentyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Date
Beschreibung

Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Start time
Beschreibung

Start time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Beschreibung

End time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual Dose
Beschreibung

Medication Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Infusion interrupted
Beschreibung

Infusion interrupted

Datentyp

boolean

Alias
UMLS CUI [1]
C1512900
Specify reason
Beschreibung

If Yes, Specify reason

Datentyp

text

Alias
UMLS CUI [1]
C0566251
Decrease of infusion rate
Beschreibung

Decrease of infusion rate

Datentyp

boolean

Alias
UMLS CUI [1]
C2964135
Specify reason
Beschreibung

If Yes, Specify reason for decrease without interruption

Datentyp

text

Alias
UMLS CUI [1]
C0566251
Infusion completed
Beschreibung

Infusion completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0205197
Specify Reason
Beschreibung

If No, Specify Reason for Incomplete Infusion

Datentyp

text

Alias
UMLS CUI [1]
C0566251
Day 2
Beschreibung

Day 2

Delay of Rituximab medication
Beschreibung

Delay of Rituximab medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0393022
Reason for delay
Beschreibung

Reason for delay

Datentyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Date
Beschreibung

Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Start time
Beschreibung

Start time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Beschreibung

End time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual Dose
Beschreibung

Actual Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Infusion interrupted
Beschreibung

Infusion interrupted

Datentyp

boolean

Alias
UMLS CUI [1]
C1512900
Specify reason
Beschreibung

Specify reason

Datentyp

text

Alias
UMLS CUI [1]
C0566251
Decrease of infusion rate
Beschreibung

Decrease of infusion rate

Datentyp

boolean

Alias
UMLS CUI [1]
C2964135
Specify reason
Beschreibung

Specify reason

Datentyp

text

Alias
UMLS CUI [1]
C0566251
Infusion completed
Beschreibung

Infusion completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0205197
Specify Reason
Beschreibung

Specify Reason

Datentyp

text

Alias
UMLS CUI [1]
C0566251
Administration of Fludarabine
Beschreibung

Administration of Fludarabine

Alias
UMLS CUI-1
C0059985
Delay of Fludarabine medication
Beschreibung

Delay of Fludarabine medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0059985
Reason for delay
Beschreibung

Reason for delay

Datentyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Fludarabine Medication
Beschreibung

Fludarabine Medication

Date
Beschreibung

Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Start time
Beschreibung

Start time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Beschreibung

End time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual dose
Beschreibung

Medication Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose adjustment
Beschreibung

Dose adjustment

Datentyp

boolean

Alias
UMLS CUI [1]
C2826232
Reason for dose adjustment
Beschreibung

Reason for dose adjustment

Datentyp

integer

Alias
UMLS CUI [1]
C2826286
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Administration of Cyclophosphamide
Beschreibung

Administration of Cyclophosphamide

Delay of Cyclophosphamide
Beschreibung

Delay of Cyclophosphamide

Datentyp

boolean

Alias
UMLS CUI [1]
C0010583
Reson for delay
Beschreibung

Reson for delay

Datentyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Cyclophosphamide Medication
Beschreibung

Cyclophosphamide Medication

Date
Beschreibung

Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Start time
Beschreibung

Start time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Beschreibung

End time

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual dose
Beschreibung

Medication Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose adjustment
Beschreibung

Dose adjustment

Datentyp

boolean

Alias
UMLS CUI [1]
C2826232
Reason for dose adjustment
Beschreibung

Reason for dose adjustment

Datentyp

integer

Alias
UMLS CUI [1]
C2826286
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

Alias
UMLS CUI [1]
C2826696
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Ähnliche Modelle

Chemotherapy Cycle 3-6 of Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration of Rituximab
Info
Item
Rituximab should be administered on the same day as Fludarabine and Cyclophosphamide administration.
text
Delay of Rituximab medication
Item
Was administration of Rituximab delayed?
boolean
C3693346 (UMLS CUI [1])
Item
integer
C1298642 (UMLS CUI [1])
Reason for delay
Code List
Reason for delay
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C3840932 (UMLS CUI [1])
Date of first dose
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Start time of first dose
Item
Start time of first dose
time
C1301880 (UMLS CUI [1])
End time of first dose
Item
End time of first dose
time
C1522314 (UMLS CUI [1])
Actual Dose of Rituximab
Item
Actual Dose of Rituximab
float
C0393022 (UMLS CUI [1])
Interrupted infusion
Item
Interrupted infusion
boolean
C0443239 (UMLS CUI [1])
Reason of interruption
Item
Reason of interruption
text
C3538832 (UMLS CUI [1])
Decrease of infusion rate
Item
Decrease of infusion rate
boolean
C2964135 (UMLS CUI [1])
Reason of decrease
Item
Reason of decrease
text
C0547047 (UMLS CUI [1])
Completion of infusion
Item
Completion of infusion
boolean
C0205197 (UMLS CUI [1])
Reason of incomplete infusion
Item
Reason of incomplete infusion
text
C0205257 (UMLS CUI [1])
Info
Item
Rituximab should be administered on the same day as Fludarabine and Cyclophosphamide
text
Lymphocyte count
Item
Does the patient have a lymphocyte count of > 25x10e9/L?
boolean
C0200635 (UMLS CUI [1])
Dosage splitting
Item
Is the Rituximab dose being split over 2 days?
boolean
C0178602 (UMLS CUI [1])
Item Group
Day 1
Delay of Rituximab medication
Item
Delay of Rituximab medication
boolean
C0393022 (UMLS CUI [1])
Item
Reason for delay
integer
C1298642 (UMLS CUI [1])
Reason for delay
Code List
Reason for delay
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual Dose
float
C3174092 (UMLS CUI [1])
Infusion interrupted
Item
Infusion interrupted
boolean
C1512900 (UMLS CUI [1])
Specify reason
Item
Specify reason
text
C0566251 (UMLS CUI [1])
Decrease of infusion rate
Item
boolean
C2964135 (UMLS CUI [1])
Specify reason
Item
Specify reason
text
C0566251 (UMLS CUI [1])
Infusion completed
Item
Infusion completed
boolean
C0574032 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Specify Reason
Item
Specify Reason
text
C0566251 (UMLS CUI [1])
Item Group
Day 2
Delay of Rituximab medication
Item
Delay of Rituximab medication
boolean
C0393022 (UMLS CUI [1])
Item
Reason for delay
integer
C1298642 (UMLS CUI [1])
Reason for delay
Code List
Reason for delay
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual Dose
float
C3174092 (UMLS CUI [1])
Infusion interrupted
Item
boolean
C1512900 (UMLS CUI [1])
Specify reason
Item
text
C0566251 (UMLS CUI [1])
Decrease of infusion rate
Item
boolean
C2964135 (UMLS CUI [1])
Specify reason
Item
text
C0566251 (UMLS CUI [1])
Infusion completed
Item
boolean
C0574032 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Specify Reason
Item
text
C0566251 (UMLS CUI [1])
Item Group
Administration of Fludarabine
C0059985 (UMLS CUI-1)
Delay of Fludarabine medication
Item
boolean
C0059985 (UMLS CUI [1])
Item
Reason for delay
integer
C1298642 (UMLS CUI [1])
Reason for delay
Code List
Reason for delay
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Item Group
Fludarabine Medication
Date
Item
date
C0011008 (UMLS CUI [1])
Start time
Item
time
C1301880 (UMLS CUI [1])
End time
Item
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual dose
float
C3174092 (UMLS CUI [1])
Dose adjustment
Item
boolean
C2826232 (UMLS CUI [1])
Item
Reason for dose adjustment
integer
C2826286 (UMLS CUI [1])
Reason for delay
Code List
Reason for dose adjustment
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Item Group
Administration of Cyclophosphamide
Delay of Cyclophosphamide
Item
Delay of Cyclophosphamide
boolean
C0010583 (UMLS CUI [1])
Item
Reson for delay
integer
C1298642 (UMLS CUI [1])
Reason for delay
Code List
Reson for delay
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Item Group
Cyclophosphamide Medication
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual dose
float
C3174092 (UMLS CUI [1])
Dose adjustment
Item
Dose adjustment
boolean
C2826232 (UMLS CUI [1])
Item
Reason for dose adjustment
integer
C2826286 (UMLS CUI [1])
Reason for delay
Code List
Reason for dose adjustment
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
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