ID

12136

Beskrivning

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

Nyckelord

  1. 2015-09-30 2015-09-30 -
  2. 2015-09-30 2015-09-30 -
  3. 2015-10-28 2015-10-28 -
  4. 2021-09-27 2021-09-27 -
Uppladdad den

30 september 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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CLL Cycle 1 FCR vs FC NCT00090051 BO17072

Chemotherapy Cycle 1 of Chronic Lymphocytic Leukemia NCT00090051 BO17072

Randomization
Beskrivning

Randomization

Alias
UMLS CUI-1
C0034656
Date of visit
Beskrivning

Date of visit

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C1320303
dd/mm/yy
Date of Randomization
Beskrivning

Date of Randomization

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0011008
dd/mm/yy
Randomization number
Beskrivning

Randomization number

Datatyp

text

Alias
UMLS CUI-1
C0237753
UMLS CUI-2
C0034656
Treatment arm
Beskrivning

Treatment arm

Datatyp

integer

Alias
UMLS CUI-1
C1522541
Reason why randomized but not treated
Beskrivning

Reason why randomized but not treated

Datatyp

text

Alias
UMLS CUI-1
C0746919
Pharmacokinetic assessments
Beskrivning

Pharmacokinetic assessments

Participation in pharmacokinetic sampling
Beskrivning

Participation in pharmacokinetic sampling

Datatyp

boolean

Alias
UMLS CUI-1
C0679823
UMLS CUI-2
C0870078
UMLS CUI-3
C0031328
Vital signs and physical measurements
Beskrivning

Vital signs and physical measurements

Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI-1
C0005910
kg
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI-1
C0005890
cm
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI-1
C0005903
°C
after al least 5 minutes rest
Beskrivning

after al least 5 minutes rest

systolic
Beskrivning

systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI-1
C0871470
mmHg
diastolic
Beskrivning

diastolic

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI-1
C0428883
kg
Pulse rate
Beskrivning

Pulse rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI-1
C0232117
bpm
"B" symptoms
Beskrivning

"B" symptoms

Fever
Beskrivning

Fever

Datatyp

boolean

Alias
UMLS CUI-1
C0015967
Night sweats
Beskrivning

Night sweats

Datatyp

boolean

Alias
UMLS CUI-1
C0028081
Weight loss
Beskrivning

Weight loss

Datatyp

boolean

Alias
UMLS CUI-1
C0043096
General physical examination
Beskrivning

General physical examination

Perform a standard physical examination but specify only abnormalities not related to CLL.
Beskrivning

General physical examination

Datatyp

text

Alias
UMLS CUI-1
C0031809
ECG
Beskrivning

ECG

Alias
UMLS CUI-1
C1623258
Date ECG performed
Beskrivning

Date ECG performed

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0011008
dd/mm/yy
Are there any abnormalities noted in the ECG?
Beskrivning

Abnormalities in the ECG

Datatyp

boolean

Alias
UMLS CUI-1
C1623258
Specification of abnormalities
Beskrivning

Specification of abnormalities

Datatyp

text

Was ECG performed?
Beskrivning

ECG

Datatyp

boolean

Alias
UMLS CUI [1]
C1623258
Laboratory analysis
Beskrivning

Laboratory analysis

Sample collection date
Beskrivning

Sample collection date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0011008
dd/mm/yy
Lab ID number
Beskrivning

Lab ID number

Datatyp

integer

Hematology
Beskrivning

Hematology

Alias
UMLS CUI-1
C0474523
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

text

Alias
UMLS CUI-1
C0019046
Hematocrit
Beskrivning

Hematocrit

Datatyp

text

Alias
UMLS CUI-1
C0518014
Red Blood Cells
Beskrivning

Red Blood Cells

Datatyp

text

Alias
UMLS CUI-1
C0362910
Leukocytes (total)
Beskrivning

Leukocytes (total)

Datatyp

text

Alias
UMLS CUI-1
C0023508
Neutrophils
Beskrivning

Neutrophils

Datatyp

text

Alias
UMLS CUI-1
C0948762
Basophils
Beskrivning

Basophils

Datatyp

text

Alias
UMLS CUI-1
C0200641
Eosinophils
Beskrivning

Eosinophils

Datatyp

text

Alias
UMLS CUI-1
C0362902
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

text

Alias
UMLS CUI-1
C0024264
Monocytes
Beskrivning

Monocytes

Datatyp

text

Alias
UMLS CUI-1
C0026473
Other cells
Beskrivning

Other cells

Datatyp

text

Platelets
Beskrivning

Platelets

Datatyp

text

Alias
UMLS CUI-1
C0005821
Prothrombin time
Beskrivning

Prothrombin time

Datatyp

text

Alias
UMLS CUI-1
C1274040
UMLS CUI-2
C0033707
UMLS CUI-3
C0022885
UMLS CUI-4
C1522609
Please comment on any abnormal other cells and specify white cell morphology
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI-1
C0947611
Blood chemistry
Beskrivning

Blood chemistry

Alias
UMLS CUI-1
C0005774
Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
Beskrivning

Aspartate transaminase (Serum glutamic oxaloacetic transaminase)

Datatyp

text

Alias
UMLS CUI-1
C0205054
UMLS CUI-2
C0242192
UMLS CUI-3
C0022877
UMLS CUI-4
C0205370
UMLS CUI-5
C1522609
Alanine transaminase (Serum glutamate-pyruvate transaminase)
Beskrivning

Alanine transaminase (Serum glutamate-pyruvate transaminase)

Datatyp

text

Alk. phosphatase
Beskrivning

Alk. phosphatase

Datatyp

text

Bilirubin total
Beskrivning

Bilirubin total

Datatyp

text

Alias
UMLS CUI-1
C0201913
Urea (BUN)
Beskrivning

Urea (BUN)

Datatyp

text

Serum creatinine
Beskrivning

Serum creatinine

Datatyp

text

Alias
UMLS CUI-1
C0201976
Lactate dehydrogenase
Beskrivning

Lactate dehydrogenase

Datatyp

text

Alias
UMLS CUI-1
C0202113
Total protein
Beskrivning

Total protein

Datatyp

text

Alias
UMLS CUI-1
C0555903
Albumin
Beskrivning

Albumin

Datatyp

text

Alias
UMLS CUI-1
C0201838
Blood glucose (random)
Beskrivning

Blood glucose (random)

Datatyp

text

Alias
UMLS CUI-1
C0202042
beta-2-microglobulin
Beskrivning

beta-2-microglobulin

Datatyp

text

Electrocytes
Beskrivning

Electrocytes

Sodium
Beskrivning

Sodium

Datatyp

text

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1274040
UMLS CUI-3
C0037473
UMLS CUI-4
C0013832
UMLS CUI-5
C1522609
Calcium
Beskrivning

Calcium

Datatyp

text

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0006675
UMLS CUI-3
C1274040
UMLS CUI-4
C0013832
UMLS CUI-5
C1522609
Potassium
Beskrivning

Potassium

Datatyp

text

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1274040
UMLS CUI-3
C0013832
UMLS CUI-4
C0032821
UMLS CUI-5
C1522609
Phosphate
Beskrivning

Phosphate

Datatyp

text

Alias
UMLS CUI-1
C0523826
Administration of Rituximab
Beskrivning

Administration of Rituximab

Date of first dose
Beskrivning

Date of first dose

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C3173309
dd/mm/yy
Start time of first dose
Beskrivning

Start time of first dose

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI-1
C1301880
hh:mm
End time of first dose
Beskrivning

End time of first dose

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI-1
C1522314
hh:mm
Actual Dose of Rituximab
Beskrivning

Actual Dose of Rituximab

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C0732355
mg
Interrupted infusion
Beskrivning

Interrupted infusion

Datatyp

boolean

Alias
UMLS CUI-1
C0443239
Reason of interruption
Beskrivning

Reason of interruption

Datatyp

text

Alias
UMLS CUI-1
C102703
Decrease of infusion rate
Beskrivning

Decrease of infusion rate without interruption

Datatyp

boolean

Alias
UMLS CUI [1]
C2964135
Reason of decrease
Beskrivning

Reason of decrease

Datatyp

text

Alias
UMLS CUI [1]
C0547047
Completion of infusion
Beskrivning

Completion of infusion

Datatyp

boolean

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

Reason of incomplete infusion

Datatyp

text

Alias
UMLS CUI [1]
C0205257
Administration of Fludarabine
Beskrivning

Administration of Fludarabine

Delay of Fludarabine medication
Beskrivning

Delay of Fludarabine medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0059985
Reason for delay
Beskrivning

Reason for delay

Datatyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Beskrivning

Specify other reason

Datatyp

text

Alias
UMLS CUI [1]
C2826696
Fludarabine Medication
Beskrivning

Fludarabine Medication

Date
Beskrivning

Date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Start time
Beskrivning

Start time

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Beskrivning

End time

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual dose
Beskrivning

Medication Dose

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose adjustment
Beskrivning

Dose adjustment

Datatyp

boolean

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

Reason for dose adjustment

Datatyp

integer

Alias
UMLS CUI [1]
C2826286
Specify other reason
Beskrivning

Specify other reason

Datatyp

text

Alias
UMLS CUI [1]
C2826696
Administration of Cyclophosphamide
Beskrivning

Administration of Cyclophosphamide

Delay of Cyclophosphamide
Beskrivning

Delay of Cyclophosphamide

Datatyp

boolean

Alias
UMLS CUI [1]
C0010583
Reson for delay
Beskrivning

Reson for delay

Datatyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Beskrivning

Specify other reason

Datatyp

text

Alias
UMLS CUI [1]
C2826696
Cyclophosphamide Medication
Beskrivning

Cyclophosphamide Medication

Date
Beskrivning

Date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Start time
Beskrivning

Start time

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Beskrivning

End time

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual dose
Beskrivning

Medication Dose

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose adjustment
Beskrivning

Dose adjustment

Datatyp

boolean

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

Reason for dose adjustment

Datatyp

integer

Alias
UMLS CUI [1]
C2826286
Specify other reason
Beskrivning

Specify other reason

Datatyp

text

Alias
UMLS CUI [1]
C2826696

Similar models

Chemotherapy Cycle 1 of Chronic Lymphocytic Leukemia NCT00090051 BO17072

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Randomization
C0034656 (UMLS CUI-1)
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI-1)
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Randomization number
Item
Randomization number
text
C0237753 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Item
Treatment arm
integer
C1522541 (UMLS CUI-1)
Code List
Treatment arm
CL Item
FCR (1)
C1880650 (UMLS CUI-1)
CL Item
FC (2)
C0280920 (UMLS CUI-1)
No treatment
Item
Reason why randomized but not treated
text
C0746919 (UMLS CUI-1)
Participation in pharmacokinetic sampling
Item
Participation in pharmacokinetic sampling
boolean
C0679823 (UMLS CUI-1)
C0870078 (UMLS CUI-2)
C0031328 (UMLS CUI-3)
Item Group
Vital signs and physical measurements
Weight
Item
Weight
float
C0005910 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI-1)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI-1)
Item Group
after al least 5 minutes rest
Blood pressure
Item
systolic
integer
C0871470 (UMLS CUI-1)
Blood pressure
Item
diastolic
integer
C0428883 (UMLS CUI-1)
Pulse rate
Item
Pulse rate
integer
C0232117 (UMLS CUI-1)
Item Group
"B" symptoms
Fever
Item
Fever
boolean
C0015967 (UMLS CUI-1)
Night sweats
Item
Night sweats
boolean
C0028081 (UMLS CUI-1)
Weight loss
Item
Weight loss
boolean
C0043096 (UMLS CUI-1)
Item Group
General physical examination
General physical examination
Item
Perform a standard physical examination but specify only abnormalities not related to CLL.
text
C0031809 (UMLS CUI-1)
Item Group
ECG
C1623258 (UMLS CUI-1)
Date
Item
Date ECG performed
date
C0011008 (UMLS CUI-1)
Abnormalities in the ECG
Item
Are there any abnormalities noted in the ECG?
boolean
C1623258 (UMLS CUI-1)
Abnormalities
Item
Specification of abnormalities
text
ECG
Item
Was ECG performed?
boolean
C1623258 (UMLS CUI [1])
Item Group
Laboratory analysis
Date
Item
Sample collection date
date
C0022885 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Lab ID number
Item
Lab ID number
integer
Item Group
Hematology
C0474523 (UMLS CUI-1)
Hemoglobin
Item
Hemoglobin
text
C0019046 (UMLS CUI-1)
Hematocrit
Item
Hematocrit
text
C0518014 (UMLS CUI-1)
RBC
Item
Red Blood Cells
text
C0362910 (UMLS CUI-1)
Leukocytes
Item
Leukocytes (total)
text
C0023508 (UMLS CUI-1)
Neutrophils
Item
Neutrophils
text
C0948762 (UMLS CUI-1)
Basophils
Item
Basophils
text
C0200641 (UMLS CUI-1)
Eosinophils
Item
Eosinophils
text
C0362902 (UMLS CUI-1)
Lymphocytes
Item
Lymphocytes
text
C0024264 (UMLS CUI-1)
Monocytes
Item
Monocytes
text
C0026473 (UMLS CUI-1)
Other cells
Item
Other cells
text
Platelets
Item
Platelets
text
C0005821 (UMLS CUI-1)
Prothrombin time
Item
Prothrombin time
text
C1274040 (UMLS CUI-1)
C0033707 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C1522609 (UMLS CUI-4)
Comment
Item
Please comment on any abnormal other cells and specify white cell morphology
text
C0947611 (UMLS CUI-1)
Item Group
Blood chemistry
C0005774 (UMLS CUI-1)
AST (SGOT)
Item
Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
text
C0205054 (UMLS CUI-1)
C0242192 (UMLS CUI-2)
C0022877 (UMLS CUI-3)
C0205370 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
ALT (SGPT)
Item
Alanine transaminase (Serum glutamate-pyruvate transaminase)
text
Alk. phosphatase
Item
Alk. phosphatase
text
Bilirubin total
Item
Bilirubin total
text
C0201913 (UMLS CUI-1)
Urea (BUN)
Item
Urea (BUN)
text
Serum creatinine
Item
Serum creatinine
text
C0201976 (UMLS CUI-1)
LDH
Item
Lactate dehydrogenase
text
C0202113 (UMLS CUI-1)
Total protein
Item
Total protein
text
C0555903 (UMLS CUI-1)
Albumin
Item
Albumin
text
C0201838 (UMLS CUI-1)
Blood glucose
Item
Blood glucose (random)
text
C0202042 (UMLS CUI-1)
beta-2-microglobulin
Item
beta-2-microglobulin
text
Item Group
Electrocytes
Sodium
Item
Sodium
text
C0022885 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0037473 (UMLS CUI-3)
C0013832 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
Calcium
Item
Calcium
text
C0022885 (UMLS CUI-1)
C0006675 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0013832 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
Potassium
Item
Potassium
text
C0022885 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0032821 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
Phosphate
Item
Phosphate
text
C0523826 (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
C0178602 (UMLS CUI-1)
C0732355 (UMLS CUI-2)
Interrupted infusion
Item
Interrupted infusion
boolean
C0443239 (UMLS CUI-1)
Reason of interruption
Item
Reason of interruption
text
C102703 (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])
Delay of Fludarabine medication
Item
boolean
C0059985 (UMLS CUI [1])
Item
Reason for delay
integer
C1298642 (UMLS CUI [1])
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])
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])
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])
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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