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ID
12246
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
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Versies (3)
- 01-10-15 01-10-15 -
- 28-10-15 28-10-15 -
- 28-10-15 28-10-15 -
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28 oktober 2015
DOI
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Licentie
Creative Commons BY-NC 3.0
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CLL Pharmacokinetics BO17072 NCT00090051
Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051
Similar models
Pharmacokinetics Cycle 1 and 3 of Chronic lymphocytic leukemia NCT0090051
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Blood sampling for pharmacokinetics (Rituximab)
Scheduled sampling time
Item
Scheduled sampling time
time
C0040223 (UMLS CUI [1])
Scheduled sampling date
Item
Scheduled sampling date
date
C0011008 (UMLS CUI [1])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1])
Sample collection date
Item
Sample collection date
date
C1549498 (UMLS CUI [1])
Sample collection time
Item
Sample collection time
time
C0427352 (UMLS CUI [1])
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
C0040223 (UMLS CUI [1])
Sampling number
Item
Sampling number
integer
C1299222 (UMLS CUI [1])
Sample collection date
Item
Sample collection date
date
C1549498 (UMLS CUI [1])
Sample collection time
Item
Sample collection time
time
C0427352 (UMLS CUI [1])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])