ID

12156

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

Keywords

  1. 10/1/15 10/1/15 -
  2. 10/28/15 10/28/15 -
  3. 10/28/15 10/28/15 -
Uploaded on

October 1, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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CLL Pharmacokinetics NCT00090051 BO17072

Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051

Blood sampling for pharmacokinetics (Rituximab)
Description

Blood sampling for pharmacokinetics (Rituximab)

Scheduled sampling time
Description

Scheduled sampling time

Data type

time

Measurement units
  • hh
hh
Scheduled sampling time
Description

Scheduled sampling time

Data type

date

Sample number
Description

Sample number

Data type

integer

Sample collection date
Description

Sample collection date

Data type

date

Measurement units
  • dd/mm/yy
dd/mm/yy
Sample collection time
Description

Sample collection time

Data type

time

Measurement units
  • hh:mm
hh:mm
Remarks
Description

Remarks

Data type

text

Alias
UMLS CUI [1]
C0947611
If patient takes Rituximab on day 1, then start of Fludarabine and Cyclophosphamide pharmacokinetic sampling starts on day 2, immediately prior the infusion.
Description

If patient takes Rituximab on day 1, then start of Fludarabine and Cyclophosphamide pharmacokinetic sampling starts on day 2, immediately prior the infusion.

Scheduled sampling time
Description

After the end of infusion

Data type

time

Measurement units
  • h
h
Sampling number
Description

Sampling number

Data type

integer

Sample collection date
Description

Sample collection date

Data type

date

Measurement units
  • dd/mm/yy
dd/mm/yy
Sample collection time
Description

Sample collection time

Data type

time

Measurement units
  • hh:mm
hh:mm
Remarks
Description

Remarks

Data type

text

Alias
UMLS CUI [1]
C0947611

Similar models

Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Blood sampling for pharmacokinetics (Rituximab)
Scheduled sampling time
Item
Scheduled sampling time
time
Scheduled sampling time
Item
Scheduled sampling time
date
Sample number
Item
Sample number
integer
Sample collection date
Item
Sample collection date
date
Sample collection time
Item
Sample collection time
time
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
Item Group
If patient takes Rituximab on day 1, then start of Fludarabine and Cyclophosphamide pharmacokinetic sampling starts on day 2, immediately prior the infusion.
Scheduled sampling time
Item
Scheduled sampling time
time
Sampling number
Item
Sampling number
integer
Sample collection date
Item
Sample collection date
date
Sample collection time
Item
Sample collection time
time
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])

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