ID

31398

Beschrijving

A Pharmacokinetic Study of Subcutaneous and Intravenous MabThera (Rituximab) in Patients With Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00930514

Link

https://clinicaltrials.gov/show/NCT00930514

Trefwoorden

  1. 19-08-18 19-08-18 -
Houder van rechten

see clinicaltrials.gov

Geüploaded op

19 augustus 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Lymphoma, Follicular NCT00930514

Eligibility Lymphoma, Follicular NCT00930514

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >=18 years of age;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
cd20-positive follicular non-hodgkin's lymphoma (nhl);
Beschrijving

Lymphoma, Non-Hodgkin; Lymphoma, Follicular; CD20 antigen positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0024301
UMLS CUI [1,3]
C3888518
partial or complete response a the end of induction treatment with mabthera;
Beschrijving

partial response | Complete therapeutic response | Induction Chemotherapy; Mabthera

Datatype

boolean

Alias
UMLS CUI [1]
C1521726
UMLS CUI [2]
C1275810
UMLS CUI [3,1]
C3179010
UMLS CUI [3,2]
C1314901
must have completed induction treatment, and received >= 1 dose of iv mabthera maintenance treatment;
Beschrijving

Induction Chemotherapy; Complete | Maintenance therapy; Mabthera; Intravenous

Datatype

boolean

Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0677908
UMLS CUI [2,2]
C1314901
UMLS CUI [2,3]
C0348016
ecog performance status of <=2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
histological evidence of transformation of nhl, or types of nhl other than follicular lymphoma;
Beschrijving

Lymphoma, Non-Hodgkin; cell transformation | Lymphoma, Follicular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0040682
UMLS CUI [2]
C0024301
presence or history of cns disease;
Beschrijving

CNS disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0007682
history of malignancy other than follicular nhl which could affect compliance with protocol or interpretation of results;
Beschrijving

Malignant Neoplasms | Lymphoma, Non-Hodgkin; Lymphoma, Follicular | Protocol Compliance | Interpretation of results

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C0024301
UMLS CUI [3]
C0525058
UMLS CUI [4]
C3526596
recent major surgery (within 4 weeks prior to screening, excluding lymph node biopsy).
Beschrijving

major surgery; Time | Biopsy of lymph node; Exclude

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0193842
UMLS CUI [2,2]
C0332196

Similar models

Eligibility Lymphoma, Follicular NCT00930514

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
adult patients, >=18 years of age;
boolean
C0001779 (UMLS CUI [1])
Lymphoma, Non-Hodgkin; Lymphoma, Follicular; CD20 antigen positive
Item
cd20-positive follicular non-hodgkin's lymphoma (nhl);
boolean
C0024305 (UMLS CUI [1,1])
C0024301 (UMLS CUI [1,2])
C3888518 (UMLS CUI [1,3])
partial response | Complete therapeutic response | Induction Chemotherapy; Mabthera
Item
partial or complete response a the end of induction treatment with mabthera;
boolean
C1521726 (UMLS CUI [1])
C1275810 (UMLS CUI [2])
C3179010 (UMLS CUI [3,1])
C1314901 (UMLS CUI [3,2])
Induction Chemotherapy; Complete | Maintenance therapy; Mabthera; Intravenous
Item
must have completed induction treatment, and received >= 1 dose of iv mabthera maintenance treatment;
boolean
C3179010 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0677908 (UMLS CUI [2,1])
C1314901 (UMLS CUI [2,2])
C0348016 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status of <=2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma, Non-Hodgkin; cell transformation | Lymphoma, Follicular
Item
histological evidence of transformation of nhl, or types of nhl other than follicular lymphoma;
boolean
C0024305 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2])
CNS disorder
Item
presence or history of cns disease;
boolean
C0007682 (UMLS CUI [1])
Malignant Neoplasms | Lymphoma, Non-Hodgkin; Lymphoma, Follicular | Protocol Compliance | Interpretation of results
Item
history of malignancy other than follicular nhl which could affect compliance with protocol or interpretation of results;
boolean
C0006826 (UMLS CUI [1])
C0024305 (UMLS CUI [2,1])
C0024301 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
C3526596 (UMLS CUI [4])
major surgery; Time | Biopsy of lymph node; Exclude
Item
recent major surgery (within 4 weeks prior to screening, excluding lymph node biopsy).
boolean
C0679637 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0193842 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])

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